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BLADDER: METASTATIC; 1st LINE: HER2 positive: SGNDV-001

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

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Malignancy

Urothelial, Transitional cell carcinoma, Bladder cancer, ureter, urethra

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st

Investigational Agent

Disitimab Vedotic

Drug Class

Anti-body drug conjugate against HER2

PI

Dan Vaena, MD

Sponsor

Seagen Inc.

Path

urothelial carcinoma

Key Eligibility Criteria Details

Inclusion Criteria:

  • Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
  • Measurable disease by investigator assessment per RECIST v1.1.
  • Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.
  • Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
  • Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to treatment initiation. If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.
  • HER2 expression of 1+ or greater on immunohistochemistry (IHC).
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.

Exclusion Criteria:

  • Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
  • History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.
  • Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.

    • CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
    • Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.
  • History of or active autoimmune disease that has required systemic treatment in the past 2 years.
  • Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).
  • Prior solid organ or bone marrow transplantation.
  • Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
  • Estimated life expectancy <12 week
  • Prior treatment with an MMAE agent or anti-HER2 therapy
BLADDER: METASTATIC: PHASE 1: ASPEN-07

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

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Malignancy

Bladder cancer, urothelial carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Evorpacept

Drug Class

Fusion protein blocking CD47-SIRPalpha

PI

Dan Vaena, MD

Sponsor

ALX Oncology

Path

Urothelial carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma. Subjects with urothelial carcinoma with squamous differentiation or mixed cell types are eligible provided that urothelial is the dominant histology.  Any element of neuroendocrine or small cell histology are excluded
  • Must have received prior treatment with a immune checkpoint inhibitor in the locally advanced or metastatic setting
  • Must have received prior treatment with platinum containing chemotherapy defined as received in the adjuvant/neoadjuvant setting with recurrent or progressive disease within 12 months of completion OR received treatment with platinum in the locally advanced or metastatic setting
  • Must have had progression or recurrence during or following recept of most recent therapy
  • ECOG PS 0-1
  • Dose escalation cohorts must have available archival or fresh biopsy sample prior to study entry.  Others must have tumor accfessible for sequential biopsy and be willing to provide fresh pre-treatment and on-study tumor tissue biopsies
  • No pre-existing sensory or motor neuropathy Grade >/= 2
  • No symptomatic or unctrolled CNS metastases
  • No prior treatment with enfortumab vedotin
  • No prior treatment with any anti-CD47 or anti-SIRPa agent
  • No known uncontrolled HBV/HCV/HIV
  • No other malignancy within 3 years
  • No active autoimmune disease requiring treatment in last year
BREAST: EARLY STAGE: HER2 POSITIVE: POST-NEOADJUVANT: RESIDUAL CANCER: ASTEFANIA

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

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Malignancy

Breast cancer, HER2 positive

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Roche/Genentech

Path

HER2 positive early breast cancer

Key Eligibility Criteria Details
  • HER2 positive invasive breast cancer
  • Stage at disease presentation: any cT2-4, any cN1-3, M0
    • Patients with cT1-3N0-1/M0 at presentation must have pathologic evidence of residual cancer in the axilla at time of surgery
    • Patients with T4 or N2-3 disease must have pathologic evidence of residual cancer in either the breast and/or the axilla
  • Completion of at least 6 cycles and 16 weeks of pre-operative systemic chemotherapy including 9 weeks of a taxane and 9 weeks of trastuzumab
  • Cannot have had a best response to neoadjuvant therapy of progressive disease
  • < or = 12 weeks since primary surgery and randomization
  • ECOG PS 0-1
  • LVEF >or = 50%
  • No prior T-DM1 or immune checkpoint inhibitors
  • Documentation of PD-L1 status
BREAST: ADJUVANT: ER+:HER2-:PREMENOPAUSAL: ONCOTYPE <25: OFSET

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

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Malignancy

Breast cancer, ER positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

chemotherapy, ovarian suppression, and endocrine therapy

Drug Class

chemotherapy, ovarian suppression, and endocrine therapy

PI

Greg Vidal, MD, PhD

Sponsor

NRG Oncology

Path

adenocarcinoma

Key Eligibility Criteria Details
  • Premenopausal
    • Age 40 years or under with spontaneous menses within 12 months
    • Age 50-60 years with spontaneous menses within 12 months plus FSH and estrodiol measurements within premenopausal range
    • Amenorrhea due to IUD or uterine ablation or hysterectomy must have FSH and estrodiol ranges in premenopausal range
  • ECOG PS 0-2
  • Multicentric or multifocal breast cancer is allowed
  • Must have had definitive breast surgery (+radiation if indicated)
  • Primary tumor must be T1-3
  • Nodes must be N0 or N1
  • Oncotype score must be,
    • if node negative: 21-25 or high clinical risk (with oncotype 16-20)
    • If 1-3 nodes, must be <26
  • Must be ER/PR positive
  • Must be HER2 negative
  • No metastatic disease
BREAST: ADJUVANT: TNBC: POST-NEOADJUVANT: TROPION-Breast03

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

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Malignancy

Breast, Triple negative breast cancer, TNBC

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

datopotamab deruxtecan (Dato-DXd)

Drug Class

ADC, Trop2 with Topo1 inhibitor payload

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

Triple negative, ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Histologically confirmed TNBC, Stage I-III
  • Residual invasive disease in the breasat and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy
  • Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab
  • No evidence of locoregional or distant relapse
  • Surgical removal of all clinically evident disease
  • ECOG PS 0-1
  • No adjuvant systemic therapy
  • LVEF > 50%
  • No known germline BRCA mutation
  • No Stage IV disease
  • No history of prior invasive breast cancer
  • No persistent toxicities from prior anticancer therapies
  • No prior autoimmune or inflammatory disorders
  • No known HIV
BREAST: METASTATIC: ER+: PRIOR CDK4/6: evERA trial

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

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Malignancy

Breast Cancer, MBC, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line endocrine

Investigational Agent

Giredestrant

Drug Class

SERD

PI

Greg Vidal, MD, PhD

Sponsor

Genentech, Inc.

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • Metastatic or locally advanced breast cancer not amenable to treatment with curative intent
  • ER+, HER2-
  • Prior endocrine therapy in combination with CDK 4/6 in either metastatic setting with disease progression after 6 months or in the adjuvant setting with relapsed disease within 12 months of exposure. (patients must have taken at least 12 months of adjuvant endocrine therapy, of which 6 months were in combination with a CDK4/6 inhibitor)
  • Measurable disease or evaluable bone mets
  • ECOG PS 0-1
  • For premenopausal or perimenopausal women or men must have treatment with LHRH agonist therapy for duration of study
  • No prior treatment with oral SERD, SERM, or everolimus. Fulvestrant is allowed if tx stopped at least 28 days prior to randomization
  • No more than 2 prior lines of systemic endocrine therapy in metastatic setting
  • No prior chemotherapy in metasatic setting
  • No other malignancy within 5 years except nonmelanoma skin cancer, papillary thyroid cancer, or very low risk of recurrence cancers
  • No known active CNS mets
BREAST: METASTATIC: HER2+: ER+: 1st Line: heredERA

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st

Investigational Agent

Giredestrant, Phesgo, taxane

Drug Class

SERD, anti-HER2

PI

Saradasri Wellikoff, MD

Sponsor

Roche

Path

HER2 positive, ER positive

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
  • Evaluable disease (measurable not required)
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months
  • ECOG PS 0-1
  • LVEF of at least (≥)50%
  • No previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
  • No prior treatment with a selective estrogen receptor degrader (SERD)
  • No previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting
  • No disease progression within 6 months of receiving trastuzumab, with or without pertuzumab, or ado-trastuzumab emtansine in the adjuvant setting
  • No history of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2.
  • No known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  • No current chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent)
  • No history of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
BREAST: METASTATIC: TNBC: 1st Line: ASCENT-03

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st or 2nd line

Investigational Agent

Sacituzumab govitecan-hziy

Drug Class

Trop-2 antibody drug conjugate

PI

Greg Vidal, MD, PhD

Sponsor

Gilead Sciences

Path

Triple negative; TNBC

Key Eligibility Criteria Details
  • Previously untreated locally advanced, inoperable, or metastatic TNBC (centrally confirmed)
    • Must be PD-L1 negative (centrally confirmed) unless treated in the adjuvant or neoadjuvant setting with PD-1 inhibitors, in which case they can be PD-L1 positive
  • Must have had at least 6 months between completion of treatment for curative intent and first documented local or distant disease recurrence (if treated for curative intent in the past)
  • Measurable disease
  • ECOG PS 0-1
  • No HIV
  • No active HBV/HCV
  • No previous topoisomerase inhibitors
BREAST: METASTATIC: TNBC: PD-L1+: 1st Line: ASCENT-04

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line

Investigational Agent

Sacituzumab govitecan, pembrolizumab

Drug Class

Trop-2 antibody drug conjugate, PD-1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Gilead Sciences

Path

TNBC, PD-L1 positive

Key Eligibility Criteria Details
  • Locally advanced, inoperable, or metastatic TNBC (centrally confirmed) without prior therapy for advanced disease
  • PD-L1 positive (centrally confirmed)
  • If patient received treatment for early disease, must have completed treatment at least 6 months prior to development of metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No prior topoisomerase inhibitors
  • No active autoimmune disease
  • If HIV positive may not have had Kaposi's sarcoma or Castleman's disease
  • No active HBV/HCV
BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 1st Line: MORPHEUS

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo

Drug Class

PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

ER- (negative), PR- (negative), HER2- (negative)

Key Eligibility Criteria Details
  • Triple negative metastatic breast cancer
  • 2nd line
  • ECOG PS 0-2
  • No prior treatment with any study agents
  • No history of autoimmune disease
  • Presence of measurable disease
  • No symptomatic or untreated CNS disease
Breast: metastatic ER+, Her2 negative first or second line MORPHEUS-BREAST

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

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Malignancy

breast cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

first or second

Investigational Agent

Giredestrant, Abemaciclib, Ipatasertib, Inavolisib, Ribociclib, Everolimus

Drug Class

multiple

PI

Gregory Vidal, MD

Sponsor

Hoffmann-La Roche

Path

ER+

Key Eligibility Criteria Details
  • ER+, Her2 negative breast cancer
  • Endocrine therapy recommended, cytotoxic chemotherapy not recommended
  • Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)
  • Postmenopausal status 
  • ECOG 0-1
  • Available tumor specimen
  • Prior fulvestrant therapy is allowed
  • Measurable disease
  • No prior cytotoxic chemotherapy for metastatic disease
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
CERVICAL: SURGICAL: ROBOTIC VERSUS OPEN HYSTERECTOMY: GOG 3043

A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)

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Malignancy

Cervical cancer, cervix

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Robotic hysterecomty

Drug Class

N/A

PI

Michael Ulm, MD

Sponsor

GOG (Gynecologic Oncology Group)

Path

Adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma (including glassy cell)

Key Eligibility Criteria Details

Inclusion Criteria:

  1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
  2. Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.
  3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
  4. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard.
  5. Patient must be age 18 years or older.
  6. Patient must have ECOG performance status 0-1.
  7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
  8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria:

  1. Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation)
  2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
  3. Patient with inability to receive an MRI.
  4. Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension).
  5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
  6. Patients with a history of prior pelvic or abdominal radiotherapy.
  7. Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer.
  8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
  9. Patient compliance and geographic proximity that do not allow adequate follow-up.
  10. Patients with poorly controlled HIV with CD4 counts <500.
COLON: ADJUVANT: Treatment based on MRD: NRG-GI008

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

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Malignancy

Colon

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

FOLFOX vs FOLFIRINOX vs active surveillance

Drug Class

chemo

PI

Noam VanderWalde, MD

Sponsor

NRG

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B.
  • No radiographic evidence of overt metastatic disease
  • Distal extent of tumor must be greater than or equal to 12cm from the anal verge
  • Must have had curative resection (en bloc)
  • Resected tumor specimen and blood must have central testing for ctDNA useing the Signatera assay
  • Must be microsatellite stable or have intact mismatch proteins
  • No more than 60 days post surgery to study entry
  • No other invasive malignancy within 5 years
  • No known active cardiac disease
COLORECTAL: METASTATIC: 1ST LINE: BRAF MT: BREAKWATER

An open-label, multicenter, randomized Phase 3 study of first-line encorafenib plus cetuximab with or without chemotherapy versus standard of care therapy with a safety lead-in of encorafenib and cetuximab plus chemotherapy in participants with metastatic BRAF V600E-mutant colorectal cancer

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Malignancy

Colon, Rectum, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Encorafenib, cetuximab

Drug Class

BRAF inhibitor, EGFR antibody

PI

Sponsor

Pfizer

Path

Key Eligibility Criteria Details
  • Age 16 or greater
  • Histologically or cytologically confirmed Stage IV CRC
  • Must contain a BRAF V600E mutation on local (FMI or Caris) or central testing
  • No prior systemic treatment in metastatic setting
  • Prior adjuvant or neoadjuvant therapy is OK only if relapse/metastasis is 6 months or greater from the end of the neo/adjuvant treatment
  • No history of acute or chronic pancreatitis
  • No symptomatic brain mets
  • Must have measurable disease
COLON: METASTATIC: BRAFmt: MSI-h: 1st Line: SEAMARK

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

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Malignancy

Colon cancer, rectal cancer, colorectal cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

encorafenib, cetuximab, pembrolizumab

Drug Class

BRAF inhibitor, EGFR mAb, PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Pfizer

Path

BRAF V600 mutant, MSI-h, dMMR

Key Eligibility Criteria Details
  • Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
  • Locally confirmed BRAF V600E mutation in tumor tissue or blood
  • ECOG PS 0 or 1
  • Have not received prior systemic regimens for metastatic disease.
  • Measurable disease
  • RAS wt
  • No known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
  • No immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
  • No presence of acute or chronic pancreatitis
  • No previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
  • No previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
COLORECTAL: METASTATIC: MSI-h: MK-1308A-008

A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

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Malignancy

Colon cancer, rectal cancer, colorectal cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

pembrolizumab/quavonlimab, pembrolizumab/favezelimab, pembrolizumab/vibostolimab, pembrolizumab+MK-4830

Drug Class

Various immunotherapy combinations

PI

Brad Somer, MD

Sponsor

Merck Sharp and Dohme

Path

Adenocarcinoma, MSI-h, dMMR

Key Eligibility Criteria Details
  • HIstologically confirmed diagnosis of Stage IV CRC
  • Locally confirmed dMMR/MSI-H
  • Life expectancy of at least 3 months
  • Measurable disease
  • Cohort A:
    • Previously treated with 5-FU, oxaliplatin, irinotecan (and anti-EGFR if KRASwt and left-sided tumor)
  • Cohort B:
    • No prior thearpy for stage IV disease
  • No prior T-cell directed therapy
  • No concurrent use of high dose steroids
  • No known CNS mets
  • No active autoimmune disease
  • No known HIV or active HBV/HCV
  • No clinically significant cardiac disease
ENDOMETRIAL: ANY STAGE: ADJUVANT: CHEMO-NAIVE: HER2+: NRG-GY026
VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Endometrial, uterine

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Trastuzumab or trastuzumab/pertuzumab

Drug Class

HER2 antibody

PI

Todd Tillmanns, MD

Sponsor

NRG Oncology

Path

Serous carcinoma or carcinosarcoma

Key Eligibility Criteria Details
  • FIGO 2009 stage IA-IVB non-recurrent, chemo-naive, HER2-positive endometrial serous carcinoma or carcinosarcoma
  • Measurable or no-measurable disease allowed
  • ECOG PS 0-2
  • No prior chemo, biologic therapy, or targeted thearpy for treatment of endometrial cancer
  • No prior radiation therapy for endometrial cancer
  • No planned radiation
  • No significant cardiac, lung, or intercurrent illness
  • Patients with prior treatment with hormonal therapy are allowed
ENDOMETRIAL: ADVANCED: MAINTENANCE: p53 WT: XPORT-EC-042

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

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Malignancy

Endometrial

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Maintenance

Investigational Agent

Selinexor

Drug Class

Selective inhibitor of nuclear export (SINE)

PI

Todd Tillmanns, MD

Sponsor

Karyopharm Therapeutics, Inc

Path

Endometrioid, serous, undifferentiated, or carcinosarcoma

Key Eligibility Criteria Details
  • Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinomsarcoma
  • TP53 WT assessed by NGS via central vendor
  • Completed a single line, at least 12 weeks, of platinum-based therapy (not including adjuvant or neoadjuvant tx for Stage 1-II disease) adn achieved confirmed PR or CR by RECIST.
  • If Primary Stage IV, may have had surgery or not. If surgery, must have had R0 or R1 resection
  • Must be able to initiate study drug 3-8 weeks following completion of final dose of chemo
  • ECOG PS 0-1
  • No uterine sarcoma
  • No concurrent systemic steroid therapy above 10mg prednisone or equivalent
  • No previous treatment with an XPO1 inhibitor
  • No active brain mets
GASTRIC: 1st Line: FGFR2b overexpression: FORTITUDE-102

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

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Malignancy

Gastric, Gastroesophageal, esophageal, stomach, esophagus

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Bemarituzumab, nivolumab

Drug Class

FGFR2b antibody, PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Amgen

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Unresectable, locally advanced, or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive by centrally performed IHC testing
  • No prior therapy for metastatic or unresectable disease except for up to 1 dose FOLFOX with or withouy nivolumab. Prior adjuvant therapy allowed as long as completed longer than 6 months prior
  • ECOG PS 0-1
  • Measurable or non-measurable disease allowed
  • No symptomatic CNS mets
  • No corneal abnormalities
  • No known HER2 positive status
  • No peripheral sensory neuropathy grade 2 or higher
GBM: Tumor Treating Fields: Post-Debulking: TRIDENT

EF-32 (TRIDENT): Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

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Malignancy

Glioblastoma multiforme, brain cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Following debulking surgery

Investigational Agent

Optune Tumor Treating Fields

Drug Class

Electric field generation

PI

Manjari Pandey, MD

Sponsor

NovoCure GmbH

Path

GBM

Key Eligibility Criteria Details
  • Histologic confirmed diagnosis of GBM per WHO classification criteria
  • Age >or= 22
  • Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
  • Planned treatment with RT-TMZ followed by TTFields and maintenance TMZ
  • KPS >or= 70%
  • Must have stable or decreasing steroid use
  • Concomitant RT with TMZ planned to start no later than 8 weeks post surgery
  • Able to undergo MRI with contrast of brain
  • No infratentorial or leptomeningeal disease
  • No plts <100, ANC <1.5, AST/ALT > 3xULN, Tbili >1.5x ULN, creatinine >1.7
  • No institutionalized patients
  • No active implanted medical devices, bullet fragments, or other skull defects
HEAD AND NECK: OROPHARYNGEAL: EARLY STAGE: HPV+ : De-intensified XRT +nivo : NRG-HN005

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

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Malignancy

Head and Neck cancer, oropharyngeal cancer, papillary squamous cell cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Definitive chemoradiation

Investigational Agent

De-instensified XRT, nivolumab

Drug Class

PI

Noam VanderWalde, MD

Sponsor

NRG Cooperative Group

Path

Squamous cell, HPV positive

Key Eligibility Criteria Details
  • Squamous cell cancer (including papillary squamous cell and basaloid, but not neuroendocrine) of the oropharynx.
  • Measurable disease at primary site or nodal stations
  • P16-positive based on local IHC staining
    • If p16 equivocal, HPV DNA is acceptable
  • Clinical stage T1-2N1M0 or T3N0-1M0. Diagnostic w/u negative for mets
  • Lifetime cumulative history of smoking cannot exceed 10 years
  • ECOG PS 0-1
  • No oral cavity, hypopharynx, or larynx cancer
  • No supraclavicular nodes
  • No prior XRT for H+N CA, no prior PD-1 therapy
  •  
LUNG: NSCLC: 1st Line: KRAS G12C mt: KRYSTAL-7

A Phase 2 Trial of MRTX849 in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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Malignancy

Non small cell lung cancer (NSCLC)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

MRTX849 (adagrasib), Pembrolizumab

Drug Class

KRAS G12C inhibitor, PD-1 inhibitor

PI

Jason Porter, MD

Sponsor

Mirati Therapeutics Inc.

Path

Non-small cell lung cancer, KRAS G12C mutation

Key Eligibility Criteria Details
  • Histologically confirmed diagnosis of metastatic or unresectable NSCLC (squamous or nonsquamous) not a candidate for definitive therapy
  • KRAS G12C mutation
  • Known PD-L1 status (can enroll regardless of level)
  • 1st line- no prior treatment for metastatic NSCLC
    • OK to have had radiosensitizing chemo >1 year prior
  • ECOG PS 0-1
  • Measurable disease
  • No active CNS mets
  • No XRT to the lungs within 6 months prior to first dose of study treatment
  • No known autimmune disease
LYMPHOMA: Follicular or DLBCL: Relapsed/refractory: Abbvie M23-362

A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting

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Malignancy

Diffuse large B-cell lymphoma, follicular lymphoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line

Investigational Agent

Epcoritamab

Drug Class

CD3 and CD20 bispecific Ab

PI

Jason Chandler, MD

Sponsor

Abbvie

Path

DLBCL, follicular lymphoma

Key Eligibility Criteria Details
  • Diagnosis of relpased or regractory diffuse large B-Cell lymphoma or R/R follicular lymphoma with documented CD20+ mature B-cell neoplasm according to WHO classification 2016 or 2008
    • Can include pts with double-hit or triple-hit DLBCL
    • Must have been previously treated wioth at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy
    • Measurable disease
    • ECOG PS 0-2
    • No CNS involvement 
MELANOMA: NEOADJUVANT: STAGE III: KEYNOTE U02-C

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02C

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab, MK-7684, V937

Drug Class

Anti-PD-1, Anti-TIGIT, Oncolytic virus

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed melanoma
  • Clinically detectable and resectable Stage IIIB, IIIC, or IIID melanoma
  • Has been untreated for the melanoma with the exception that primary lesion may have been resected or irradiated
  • No known CNS mets
  • No ocular or mucosal melanoma
  • No known HIV/HBV/HCV
  • No active autoimmune disease requiring therapy in past 2 years
  • Must not have received prior oncolytic viruses
MELANOMA: ADJUVANT: STAGE III: PD1+/- LAG3: RELATIVITY-098

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

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Malignancy

Melanoma

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Relatlimab, Nivolumab

Drug Class

LAG3 inhibitor, PD-1 inhibitor

PI

David Portnoy

Sponsor

Bristol Myers Squibb

Path

Key Eligibility Criteria Details
  • Must have been diagnosed with either Stage IIIA (>1mm tumor in lymph node), Stage IIIB, Stage IIIC, Stage IIID, or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected with negative margins
  • ECOG PS 0-1
  • Resection must have been performed within 12 weeks prior to randomization
  • Tumor tissue available
  • No history of uveal melanoma
  • No untreated CNS metastases
MELANOMA: ADJUVANT: Pembro+anti-TIGIT: KEYVIBE-010

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

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Malignancy

Cutaneous Melanoma

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

pembrolizumab and vibostolimab

Drug Class

anti-PD1, anti-TIGIT

PI

David Portnoy, MD

Sponsor

Merck Sharp and Dohme

Path

Melanoma

Key Eligibility Criteria Details
  • Surgically resected and histologically or pathologically confirmed melanoma
  • Must be Stage IIB, IIC, III, or IV cutaneous melanoma
  • No prior systemic therapy for melanoma
  • No more than 12 weeks between final surgical resection and randomization
  • HBV/HCV/HIV are allowed if well controlled
  • No ocular, conjunctival, or mucosal melanoma
  • No diagnosis of immunodeficiency or receiving chronic systemic steroids >10mg prednisone or equivalent
  • No active autoimmune disease
  • No active CNS disease
  • No other malignancy that required active treatment in last 3 years
MELANOMA:Metastatic: 1st Line: KEYNOTE-U02-B

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02B.

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line, PD-1 naive

Investigational Agent

Multiple

Drug Class

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has been untreated for advanced disease
  • No ocular or mucosal melanoma
  • No known additional malignancy that is progressing or requires active treatment within the past two years
  • No known CNS metastatses
  • No active autoimmune disease requiring systemic treatment in the past two years
  • No known HIV/HBV/HCV
  • Adequate organ function
MELANOMA: Metastatic: PD-1 refractory: KEYNOTE-U02-A

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02A.

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Malignancy

Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line (post PD-1)

Investigational Agent

Multiple

Drug Class

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma not amenable to curative therapy
  • Has progressed on treatment with an anti-PD1/L1 monoclonal antibody administered either as monotherapy or in combination with other therapies
  • Hsa not received more than 3 lines of therapy
  • No known additional malignancy with past 2 years
  • No known CNS metastases
  • No active autoimmune disease requiring systemic treatment in the last 2 years
  • No known HIV/HBV/HCV
MELANOMA: 2nd line: PD-1 + HSV-virus: RPL-001-16

An open-label, multicenter, Phase 1/2 study of RP1 as a single agent and in combination with PD1 blockade in patients with solid tumors

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Malignancy

Melanoma, Skin Cancer, ocular melanoma, mucosal melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd

Investigational Agent

RP1 + nivolumab

Drug Class

Oncolytic virus

PI

Ari VanderWalde, MD

Sponsor

Replimune Inc.

Path

Melanoma

Key Eligibility Criteria Details
  • Stage IIIB-IV melanoma, following progression on PD-1 containing regimen
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measruable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
MYELOMA: Relapsed/Refractory: 1-3 prior therapies: SUCCESSOR-1

A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

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Malignancy

Multiple myeloma

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line through 4th line

Investigational Agent

CC-92480, bortezomib, dexamethadose (480Vd)

Drug Class

CRBN-E3 ligase modulating drug

PI

Jason Chandler, MD

Sponsor

Bristol Myers Squibb

Path

Multiple myeloma

Key Eligibility Criteria Details
  • Subject has documented diagnosis of MM and measurable disease, defined as any of the following:
    • M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or 
    • M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or
    • For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
  • Subject has received 1 to 3 prior lines of antimyeloma therapy. (Note: One line can contain several phases [eg, induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and/or (with or without) maintenance therapy
  • Must have received prior treatment with a lenalidomide-containing regimen
  • Must have achieved minimal response or better to at least 1 prior antimyeloma therapy
  • Must have documented disease progression during or after their last antimyeloma therapy
  • ECOG PS 0-2
  • May not have had progression during treatment or within 60 days of the last dose of a proteasome inhibitor
  • If prior treatment with a bortezomib containing regimen, must have had a best response of minimal response or better and the subject could not have discontinued bortezomib due to toxicity
  • No prior allo transplant
  • No plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or clinically significant light-chain amyloidosis
  • No known CNS involvement of myeloma
  • No grade 2 or higher peripheral neuropathy
  • No other malignancy within 5 years
  •  
OVARIAN: RECURRENT: PLATINUM SENSITIVE: 3rd LINE: FOLATE-RECEPTOR+: GLORIOSA

Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)

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Malignancy

Ovarian, Fallopian Tube, Primary Peritoneal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd Line

Investigational Agent

Mirvetuximab soravtansine plus bevacizumab

Drug Class

Ab drug conjugate against folate receptor alpha + VEG-F inhibitor

PI

Todd Tillmanns, MD

Sponsor

Immunogen, Inc.

Path

High grade serous ovarian/primary peritoneal/fallopean tube cancer

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • If patients are BRCA positive, must have received treatment with PARP inhibitors
  • Must be folate receptor alpha positive as defined by FRa positivity of >75% of tumor membrane staining at 2+ intensity or higher.
  • Disease must have relapsed after 1 line of platinum-based therapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy
  • Must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line. Must have received no less than 4 and no greater than 8 cycles in the second line
  • Must have receirved, be currently be receiving, or be planned to receive paclitaxel, gemcitabine, pegylated lipsomal doxorubicin as the partner drug to platinum based therapy
  • After completion of platinum based triple therapy and before randomization, patient must have achieved a CR, pR, or SD
  • Before randomization must have either a) measurable disease, b) persistently elevated CA-125 or c) no evidence of disease and normalization of CA-125
  • No endometrioid, clear cell, mucinous, or sarcomatous histology
  • No more than 1 line of prior chemotherapy before planned triplet therapy
  • No PD while on triple therapy
  • No cirrhotic liver disease
  • No severe cardiac disease
  • No history of bowel obstruction, abdominal fistula, or GI perforation
  • No folate deficiency
  • No other malignancy within 3 years
OVARIAN: METASTATIC: Plat Resistant: HIGH GRADE: 2nd Line: ROSELLA

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

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Malignancy

Ovary, Ovarian, Primary peritoneal, fallopian tube

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Relacorilant

Drug Class

Glucocoricoid receptor antagonist

PI

Todd Tillmanns, MD

Sponsor

Corcept Therapeutics

Path

High risk epithelial

Key Eligibility Criteria Details
  • High grade (grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma
  • Platinum resistant disease (defined progression <6 monhths from completion of a platinum containing therapy)
  • Measurable disease
  • ECOG PS 0-1
  • Received at least 1 but < or = 3 lines of prior systemic anticancer therapy.
  • Prior treatment with bevacizumab is required
  • No low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies
  • No primary platinnum refractory disease
  • No requirement of treatment with chronic or frequent use of oral steroids
  • No concurrent treatment with mifepristone or other GR modulators
  • No peripheral neuropathy
  • No symptomatic CNS disease
PANCREATIC: METASTATIC: FIRST-LINE: Actuate 1801

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors (pancreatic cohort)

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Malignancy

Pancreatic cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

9-ING-41

Drug Class

GSK-3beta inhibitor

PI

Brad Somer, MD

Sponsor

Actuate Therapeutics Inc.

Path

Pancreatic adenocarcinoma

Key Eligibility Criteria Details
  • Pathologically or cytologically confirmed metastatic pancreatic cancer
  • Previously untreated with systemic agents in recurrent/metastatic setting
  • Measurable disease
  • May have received adjuvant therapy if given at least 6 months before study enrollment
  • No significant cardiovascular impairment
  • No other malignancy
  •  
PROSTATE: METASTATIC: Pembro+Lenvatinib: 2nd or 3rd line chemo: KEYNOTE-365 ARM E

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

> or - 2nd line

Investigational Agent

Pembrolizumab, Lenvatinib

Drug Class

PD-1 inhibitor, VEG-F TKI

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate Adenocarcinoma without small cell histology

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
  • Must provide a core or excisional biopsy from soft tissue or bone biopsy from soft tissue within 1 year of screening and after developing mCRPC
  • Has prostate cancer progression within 6 months prior to screening by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
  • Ongoing androgen deprivation with serum testoterone <50ng/dL
  • Stable doses of bone resorptive therapy
  • ECOG PS 0-1
  • Has previously received docetaxel for mCRPC. Prior treatment with one other chemotherapy is allowed. Up to 2 second-generation hormonal agents (eg. abiraterone, enzalutimide, etc.) are allowed. Prior ketoconazole is allowed. Docetaxel used more than once is considered as 1 therapy.
  • No diagnosis of immunodeficiency or systemic steroid therapy
  • No autoimmune disease within last 2 years
  • No known HBV/HCV/HIV
  • No known active CNS mets
  • No superscan bone scan
  • No active cardiovascular disease
  • No gastrointestinal malabsortion
  • No active hemoptysis
PROSTATE: METASTATIC: NEUROENDOCRINE >/= 1st Line: Pembro+Lenvatinib: KEYNOTE-365 ARM F

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

Pemrbolizumab and Lenvatinib

Drug Class

PD-1 inhibitor, VEGF TKI

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Neuroendocrine castration resistant prostate cancer

Key Eligibility Criteria Details
  • Has treated or de novo neuroendocrine  metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
  • Must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
  • Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL
  • Patients receiving bone resorptive therapy must be on stable doses
  • ECOG PS 0-1
  • Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, etc.) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. A limited number of de novo patients may enroll after consultation with the sponsor.
  • No prior treatment with Radium or Lutitium
  • No immunodeficiency or systemic steroids
  • No autoimmune disease within the last 2 years
  • No known HIV/HBV/HCV
  • No known CNS mets
  • No superscan bone scan
  • No active cardiovascular disease
  • No active hemoptysis
PROSTATE: METASTATIC: 2nd line or greater: Pembro/Vibostolimab: KEYNOTE-365 ARM G

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

Pembrolizumab Vibostolimab coformulation

Drug Class

PD-1 inhibitor + Anti-TIGIT

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC. Participants with bone metastasis only must provide an archival tumor tissue specimen.
  • Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. 
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
  • Patients receiving bone resorptive therapy must be on stable doses
  • ECOG PS 0-1
  • Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed. Participants who received prior ketoconazole for metastatic disease may be enrolled. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. Prior docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1
  • No immunodeficiency or systemic steroid use
  • No active autoimmune disease within 2 years
  • No known HIV/HBV/HCV
  • No known CNS mets
  • No superscan bone scan
  • No symptomatic ascites or pleural effusion
PROSTATE: METASTATIC: NEUROENDOCRINE: treated or de novo: Pembro/Carbo/Etop: KEYNOTE-365 ARM I

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Treated or de novo

Investigational Agent

Pembrolizumab, Carboplatin, Etoposide or Carbo/Etoposide alone

Drug Class

PD-1 inhibitor, chemo

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate cancer with neuroendocrine features

Key Eligibility Criteria Details
  • Has  treated or de novo metastatic neuroendocrine prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
  • Must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
  • Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL 
  • Patients receiving bone resorptive therapy must be on stable doses
  • ECOG PS 0-1
  • Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, darolutamide, enzalutamide, or other NHA) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. A limited number of de novo patients will be allowed to enroll based on consultation with the study team.
  • No immunodeficiency or systemic steroid use
  • No autoimmune disease within last 2 years
  • No known HIV/HBV/HCV
  • No known active CNS mets
  • No superscan bone scan
  • No symptomatic ascited or pleural effusion
  • No prior treatment with platinum containing compounds for prostate cancer
PROSTATE: METASTATIC: NEUROENDOCRINE >/= 1st Line: Pembro/Vibostolimab: KEYNOTE-365 ARM H

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line chemo or later

Investigational Agent

Pembrolizumab/Vibostolimab

Drug Class

PD-1/anti-TIGIT coformulation

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate Adenocarcinoma without small cell histology

Key Eligibility Criteria Details
  • Has treated or de novo neuroendocreine metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
  • Must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
  • Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL
  • Patients receiving bone resorptive therapy must be on stable doses
  • ECOG PS 0-1
  • Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, darolutamide, enzalutamide, or other NHA) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. A limited number of de novo neuroendrcine CRPC patients will be allowed to enroll with consultation with the study team.
  • No immunodeficiency or systemic steroid use
  • No autoimmune disease within last 2 years
  • No known HIV/HBV/HCV
  • No known CNS mets
  • No superscan bone scan
  • No symptomatic ascites or pleural effusion
RECTAL: ADJUVANT: POST RT: FOLFIRINOX: JANUS

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

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Malignancy

Rectal cancer, CRC

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

FOLFIRINOX

Drug Class

Chemotherapy

PI

Noam VanderWalde, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Clinical stage II or III rectal adenoCA defined as T4N0 or any T with node positive disease. T3N0 requiring APR or coloanal astamosis is also allowed
  • No prior systemic non-surgical treatment for rectal cancer within last 5 years
  • ECOG PS 0-2
  • No upper rectal tumors (>12 cm above anal verge)
  • No recurrent rectal cancer
  • No known MMR deficient cancer
RENAL CELL: CLEAR CELL: ADJUVANT: PEMBRO+/- Belzutifan: MK-6482-022

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the
Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus
Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

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Malignancy

Renal Cell Carcinoma, Kidney cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Belzutifan

Drug Class

HIF-2a inhibitor

PI

Brad Somer, MD

Sponsor

Merck Sharp and Dohme LLC

Path

clear cell

Key Eligibility Criteria Details

Inclusion Criteria:

  • Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
  • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:

    1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
    2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
    3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
  • Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
  • Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
  • ECOG PS 0-1
  • Must not have a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
  • No clinically significant cardiovascular disease within 6 months from first dose of study intervention
  • No preexisting brain or bone metastatic lesions
  • No prior systemic therapy for RCC
  • No prior radiotherapy for RCC
  • No diagnosis of immunodeficiency or receiving chronic systemic steroid therapy
  • No known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
  • No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
  • No history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • No known HIV/HBV/HCV
SARCOMA: LIPOSARCOMA: METASTATIC: MDM2+: BRIGHTLINE-4

Brightline-4: A Phase III Open-label, Single-arm, Multi-center Study to Assess the Safety and Efficacy of Brigimadlin (BI 907828) Treatment in Patients With Treatment-naïve or Pre-treated Advanced Dedifferentiated Liposarcoma

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Malignancy

Liposarcoma, sarcoma

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Birmigadlin (BI 907828)

Drug Class

MDM2 inhibitor

PI

David Portnoy, MD

Sponsor

Boeringer Ingelheim

Path

Dedifferentiated liposarcoma

Key Eligibility Criteria Details
  1. Histologically documented locally advanced or metastatic, unresectable (i.e. surgery morbidity would outweigh potential benefits), progressive or recurrent Dedifferentiated liposarcoma (DDLPS), meeting the criteria for an open study cohort:

    • Cohort A: patient has not received prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
    • Cohort B: patient has received any prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
  2. Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS)
  3. Measureable disease
  4. ECOG PS 0-1
  5. No known mutation in TP53
  6. No prior MDM2 inhibitor
  7. No prior or concomittant cancers within 2 years except non-melanoma skin cancers, or other treatment curative by local therapy only
SKIN SQUAMOUS CELL: Recurrent: Intratumoral XRT: Alpha DaRT224-03

A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

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Malignancy

Squamous cell skin cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line

Investigational Agent

DaRT224

Drug Class

Intratumoral encapsulated radium-224

PI

Noam VanderWalde, MD

Sponsor

Alpha Tau Medical

Path

Squamous cell carcinoma

Key Eligibility Criteria Details
  • Patients with recurrent cutaneous SCC histologically confirmed who have failed at least first line standard of care therapy who are not indicated for surgery and standard radiation therapy, or non alpha radiation brachytherapy technologies, and for whom no curative systemic treatment is available
  • Histopathological confirmation following previous treatment
  • Measurable disease
  • One single lesion
  • Tumor size </= 7cm
  • Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye)
  • ECOG PS 0-2
  • No distant or nodal metastatic disease
  • No T4 disease or perineural spread
  • No previously untreated disease indicated for surgery or radiation
  • No mucosal, vulvar, anal, or penile SCC
  • No systemic immunosuppresive therapy
  • No keratoacanthoma histology
  • No clinically significant cardiovascular disease
SKIN CANCER: Non-melanoma: PD-1 eligible: PD-1 and oncolytic virus: RP-001-16

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

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Malignancy

Non-melanoma skin cancer, basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

No prior PD-1

Investigational Agent

RP1, nivolumab

Drug Class

oncolytic virus (HSV), PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Replimune, Inc.

Path

Basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, basosquamous carcinoma, high-grade dermatofibroma protuberans, angiosarcoma of the skin, non-HIV-related Kaposi sarcoma, sebaceous gland carcinome, eccrine carcinomas

Key Eligibility Criteria Details
  • Diagnosis of locally advanced or metastatic non-melanoma skin cancer not considered treatable by surgery. Could include;
    • Basal cell carcinoma,
    • Cutaneous squamous cell carcinoma,
    • Merkel cell carcinoma
    • Angiosarcoma of the skin
    • Eccrine carcinoma
    • high grade dermatofibroma protuberans
    • CTCL is NOT allowed
  • Must have exhausted or refused currently available therapy
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measurable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
MOLECULARY TARGETED: ROS1 FUSION (TAPISTRY ARM A)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort A: Entrectinib in patients with ROS1 fusion-positive tumors

 

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Malignancy

Solid Tumors except for NSCLC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Entrectinib

Drug Class

selective tyrosine kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • ROS1 fusion positive solid malignancies (except for NSCLC)
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: NTRK1/2/3 FUSION (TAPISTRY ARM B)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort B: Entrectinib in patients with NTRK1/2/3 fusion-positive tumors

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Malignancy

any solid tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Entrectinib

Drug Class

selective tyrosine kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Any Solid Malignancy with NTRK1/2/3 Fusion Positivity
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: ALK FUSION (TAPISTRY ARM C)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort C: Alectinib in patients with ALK fusion-positive tumors

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Malignancy

any solid tumors except for NSCLC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Alectinib

Drug Class

selective tyrosine kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with any ALK fusion positive solid malignancy except NSCLC
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: PIK3CA Multiple Mutant Tumors (TAPISTRY ARM H)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort H: Inavolisib (GDC-0077) in patients with PIK3CA multiple mutant-positive tumors

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Malignancy

Solid Tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Inavolisib (GDC-0077)

Drug Class

PI3K-p110α (PIK3CA) inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with at metastatic or advanced solid tumors with at least 2 PIK3CA mutations
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: BRAF II Mutant or Fusion/BRAF III Tumors (TAPISTRY ARM I/J)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohorts I/J: Belvarafenib in patients with BRAF class II mutant/fusion-positive tumors (I) BRAF class III mutant positive tumors (J)

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Malignancy

Solid Tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Belvarafenib

Drug Class

Type II pan-RAF kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with advanced or solid malignancy with BRAF class II mutation or fusion (ARM I)
  • Patients with advanced or solid malignancy with BRAF class III mutation (ARM J)
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: RET Fusion Positive Tumors (TAPISTRY ARM K)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort K: Pralsetinib in patients with RET fusion-positive tumors

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Malignancy

Solid Tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Pralsetinib

Drug Class

RET tyrosine kinase inhibitor

PI

Sponsor

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with advanced or malignant solid cancers with RET-fusion positive tumors.
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
ADVANCED SOLID TUMORS: METASTATIC: TSC1/TSC2 alterations: last line: PRECISION 1

A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.

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Malignancy

Breast, lung, colon, prostate, bladder, RCC, kidney, skin, melanoma, gastric, pancreatic, HCC, rectal, sarcoma, head and neck, esophagus, biliary tract

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

nab-sirolimus

Drug Class

MTOR inhibitor

PI

Dan Vaena, MD

Sponsor

Aadi Bioscience, Inc.

Path

TSC1 or TSC2 alterations

Key Eligibility Criteria Details
  • Malignant solid tumor with pathogenic inactivating TSC1 or TSC2 alterations. GEnetic alterations should be identified using NGS in tumor tissue or liquid biopsy
  • Metastatic or locally advanced solid tumors
  • Must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the investigator, the patient would b e unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
  • Measurable disease
  • ECOG PS 0-1
  • Fasting tryglecerid must be < or = 300; fast serus cholesterol must be < or = to 350
  • No prior treatment with MTOR inhibitor
  • No primary brain tumors
  • No known HIV
Advanced Solid Tumors: Niraparib and Dostarlimab in HRD Solid Tumors

A Phase II Trial of Niraparib and Dostarlimab Combination Therapy in Patients
with Somatic Homologous Recombination Deficient Advanced or Metastatic
Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

solid tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Niraparib and Dostarlimab

Drug Class

PARP inhibitor + IgG4 humanized monoclonal antibody resulting in PDL1/2 inhibition.

PI

Gregory Vidal, MD

Sponsor

West Cancer Center

Path

somatic HRD deficiency

Key Eligibility Criteria Details
  1. Metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic mutation of one of the following homologous recombination deficiency (HRD) gene mutations:  BRCA1, BRCA2, ATM, RAD51B, RAD51C, RAD54L, RAD51D, FANC/BRIP1, FANCI, FANCL, FANCN(PALB2), BARD1, CHEK1, CHEK2, CDK12, or PPP2R2A.

  2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  3. Participant must be ≥ 18 years of age
  4. Participant must have adequate organ function, defined as follows:

    • Absolute neutrophil count ≥ 1,500/µL
    • Platelets ≥ 100,000/µL
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min using the Cockcroft-Gault equation
    • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
    • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
    • International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  5. Female participant has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to use a highly effective method of contraception from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
    • ≥45 years of age and has not had menses for >1 year
    • Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
    • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use an adequate barrier method throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 5.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

h. Male participant agrees to use a highly effective method of contraception (see Section 5.4 for a list of acceptable birth control methods) starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

j. If an appropriate archival tumor tissue sample is not available, patient is willing to undergo a pre-treatment tumor biopsy.

Exclusion Criteria:

  1. Patients with the following malignancies will be excluded:

    • Prostate cancer
    • Ovarian, breast, and pancreatic patients with known germline BRCA1 or BRCA2 mutation
    • Platinum sensitive ovarian cancer (defined as recurrence > 6 months from last platinum agent), unless platinum intolerant.
ADVANCED SOLID TUMORS: PHASE 1: TOLL-LIKE RECEPTOR AGONIST AB CONJUGATE: INCLINE-101

A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Lung, Colon, Prostate, Bladder, Kidney (renal cell), Ovarian, Endometrial (uterine), Cervical, Head and Neck, Melanoma, GBM, Stomach, Liver (HCC), Pancreatic, Gastric, Esophageal, Sarcoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

TAC-001

Drug Class

T-cell receptor agonist antibody drug conjugate

PI

Dan Vaena, MD

Sponsor

Tallac Pharmaceuticals

Path

Histologic documentation

Key Eligibility Criteria Details

Inclusion Criteria:

  1. Histologically or cytologically-documented solid tumors.
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  3. Demonstrate adequate organ function.

Exclusion Criteria:

  1. Prior history of or active malignant disease other than that being treated in this study.
  2. Known brain metastases or cranial epidural disease.
  3. A known hypersensitivity to the components of the study therapy or its' analogs.
ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
  • Must have tumor specimen available
  • Measurable disease
  • ECOG PS 0-1
  • Life expectancy at least 12 weeks
  • Phase 1a- must have exhausted all standard therapies for their disease
  • Phase 1b- must have disease that has progressed after at least one available standard therapy
  • Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
  • No active HBV/HCV or chronic or acute EBV
  • No history of autoimmune disease
  • No symptomatic or actively progressing CNS mets
ADVANCED SOLID TUMORS: PHASE 1: NKG2A inhibitor: CA047004

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination with Nivolumab or
Cetuximab in Participants with Advanced Solid Tumors

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Malignancy

Advanced Solid Tumors, renal cell, head and neck cancer (SCCHN), non-small cell lung cancer (NSCLC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

> or = 2nd line

Investigational Agent

BMS-986315 with either nivolumab or cetuximab

Drug Class

NKG2A inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

Key Eligibility Criteria Details
  • Renal cell, NSCLC, or SCCHN
  • Must have received prior PD-1 or PD-L1 inhibitor
  • ECOG PS 0-1
  • No known autoimmune disease
  • No need for steroids or other immunsuppressive medicine
  • No interstitual lung disease or pulmonary fibrosis
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