Receive monthly emails about the latest oncology research and technology, new patient services, resources and more!

Please select an option below to help us tailor your newsletter to best suit your content interests!

No thanks
Stage
Phase
Status
Reset Filter
BREAST: EARLY STAGE Breast Conservation Selene Margin status

A prospective, multi-center, randomized, double-arm trial to determine the impact of the SELENE system on positive margin rates in breast conservation surgery

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

First line

Investigational Agent

Selene

Drug Class

Optical Coherence Tomography (OCT)

PI

Richard Fine, MD

Sponsor

PERIMETER

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
  • May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Male
  • Metastatic cancer (Stage IV)
  • Lobular carcinoma as primary diagnosis
  • Previous ipsilateral breast surgery for benign or malignant disease (this includes implants and breast augmentation)
  • Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
  • Subjects with bilateral disease (diagnosed cancer in both breasts)
  • Participating in any other investigational margin assessment study which can influence collection of valid data under this study
  • Use of cryo-assisted localization
  • Currently lactating
  • Current pregnancy
  • Subjects undergoing breast conserving surgery whose resected specimen will be evaluated with intraoperative pathology, frozen section, or imprint cytology
BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Neratinib

Drug Class

HER2 targeted small molecule

PI

Greg Vidal, MD, PhD

Sponsor

West Cancer Center, Puma Biotechnology, Celcuity

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
  • ER/PR <10%, HER2 negative
  • ECOG PS 0-1
  • ANC >1200, Hgb >10, Plt >100,000
  • Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
  • No T3 or T4 tumors
  • No definitive surgical treatment performed yet
  • No evidence of metastatic disease
  • No prior history of ipsilateral DCIS or breast cancer
  • No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
  • No other malignancies within 2 years prior
  • No active cardiac disease
  • No uncontrolled hypertension
  • No known HIV/HBV/HCV
  • No neuropathy grade >=2
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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: Metastatic: ER+, HER2neg, 1st line: persevERA

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line (pre-chemo)

Investigational Agent

GDC-9545

Drug Class

Selective estrogen receptor degrader (SERD)

PI

Greg Vidal, MD, PhD

Sponsor

Hoffmann-LaRoche

Path

ER+ (positive), HER2 - (negative)

Key Eligibility Criteria Details
  • Postmenopausal or pre-menopausal but treated with LHRH agonist therapy for the duration of study treatment
  • Locally advanced or metastatic adenocarcinoma of the breast not curable
  • Documented ER-positive and HER2-negative
  • No prior systemic anti-cancer therapy for metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No disease recurrence within 12 months of treatment with an AI or a CDK4/6 inhibitor in adjuvant/neoadjuvant setting
  • No prior SERD
  • No active CNS disease
BREAST: METASTATIC: HER2+:1ST LINE: DESTINY BREAST-09

Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Trastuzumab Deruxtecan

Drug Class

Anti-body drug conjugate against HER2

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

HER2+ (IHC 3+ or FISH+)

Key Eligibility Criteria Details
  • Advanced or metastatic breast cancer that is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) with known horme receptor status
  • No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.
  • No more than 1 previous line of endorcrine therapy in the metastatic setting
  • Adjuvant/neo-adjuvant therapy allowed if >6 months from treatment to metastatic diagnosis
  • ECOG PS 0-1
  • No clinically active CNS disease
  • No active ILD/pneumonitis
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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-03

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

VIEW TRIAL ON CLINICALTRIALS.GOV
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: HER2 low (IHC 1+, 2+): DESTINY-BREAST08

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, IDC, ILC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st, 2nd, or 3rd depending on bucket

Investigational Agent

trastuzumab deruxtecan (T-DXd). Various arms contain durvalumab, paclitaxel, capivasertib, anastrozole, fulvestrant, and capectabine

Drug Class

HER2 antibody drug conjugate

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

HER2 IHC 1+ or IHC2+ with negative ISH

Key Eligibility Criteria Details
  • Breast cancer with history of HER2-low expression, defined as IHC2+/ISH negative or IHC1+ with a validated assay
  • May be either hormone receptor positive or negative
  • ECOG PS 0-1
  • If hormone receptor positive disease
    • Part 1: Must have had at least 1 prior treatment line of endocrine therapy with or without a targeted therapy (CDK4/6, mTOR, or PI3K) and at least one prior line of chemotherapy, all for metastatic disease
    • Part 2: Only 1 prior treatment line of ET with or without a targeted therapy. No prior chemothearpy for MBC
  • If hormone receptor negative disease
    • Part 1: At least 1 prior line of chemotherapy for MBC
    • Part 2: For Module 2, no prior lines of thearpy for MBC. For Modules 1 and 3, only 1 prior line fo chemotherapy for MBC
  • No significant cardiovascular disease
  • No history of pneumonitis requiring steroids
    • No clinically active CNS metastatses or spinal cord compression
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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
COLON: ADJUVANT: Treatment based on MRD: NRG-GI008

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

VIEW TRIAL ON CLINICALTRIALS.GOV
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
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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: Oropharynx: HPV+: Early Stage: XRT: HN 005

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Head and Neck, Oropharyx, Oropharyngeal cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Reduced dose radiation with chemo or IO

Drug Class

XRT

PI

Noam VanderWalde, MD

Sponsor

NRG Oncology

Path

HPV positive (+)

Key Eligibility Criteria Details
  • Squamous cell carcinoma of the oropharynx
  • Measurable disease either in primary or lymph node
  • P16 posotive locally
  • T1-2N1M0 or T3N0-1M0
  • No more than 10 pack years of smoking history
  • ECOG PS 0-1
  • No T4 or N2
  • No recurrent disease
  • No supraclavicular nodes
  • No prior malignancy unless disease free for at least 3 years
  • No allergy to cisplatin
Head and neck: Metastatic: 2nd line: Buparlasib: BURAN

The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Head and Neck cancer, oropharynx, hypopharynx, larynx, oral cavity, hypopharyngeal, oropharyngeal, laryngeal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line

Investigational Agent

Buparlisib

Drug Class

PI3K inhibitor

PI

Gary Tian, MD

Sponsor

Adlai Nortye Biopharma Co.

Path

Head and neck cancer

Key Eligibility Criteria Details
  • Must have one of the following
    • Disease progression after platinum based chemotherapy (with or without PD-1 therapy) for recurrent or metastatic disease
    • Refractory disease defined as progression or recurrence within six months after the last dose of platinum based chemoradiation for locally advanced disease
  • No more than two prior lines of treatment
  • ECOG PS 0-1
  • Able to swallow and retain oral medications
  • No prior taxane
  • No symptomatic CNS disease
  • No known HIV
  • No symptomatic CHF or LVEF <50%
  • No active psychiatric illness
Head And Neck: 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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Head and neck cancer (SCCHN), laryngeal, hypopharyngeal, oropharyngeal, oral cavity, oropharynx, hypopharynx, larynx

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

squamous cell carcinoma

Key Eligibility Criteria Details
  • 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
DLBCL: MorphoSys AG: Tafasitamab plus lenalidomide

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the
efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus
R-CHOP in previously untreated, high-intermediate and high-risk patients with newlydiagnosed
diffuse large B-cell lymphoma (DLBCL) [frontMIND]

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lymphoma

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

First line

Investigational Agent

Tafasitamab plus lenalidomide

Drug Class

Anti-CD19 humanized monoclonal antibody

PI

Jason Chandler, MD

Sponsor

MorphoSys AG

Path

Diffuse Large B cell Lymphoma

Key Eligibility Criteria Details

Major Inclusion Criteria:

  • Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:

    1. DLBCL, NOS including GCB type, ABC type
    2. T-cell rich large BCL
    3. Epstein-Barr virus-positive DLBCL, NOS
    4. Anaplastic lymphoma kinase (ALK)-positive large BCL
    5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
    6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study
    7. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
    8. FL grade 3b
  • Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review
  • IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age)
  • Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing lymphoma according to the local pathology report) and the start of treatment (C1D1) ≤ 28 days
  • ECOG performance status of 0, 1, or 2
  • Left ventricular ejection fraction equal to or greater than lower limit of institutional normal range, assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
  • Adequate hematologic function
  •  

Major Exclusion Criteria:

  • Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma
  • History of prior non-hematologic malignancy except for the following:

    1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
    2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
    3. Adequately treated carcinoma in situ without current evidence of disease
  • Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
  • Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
  • Known CNS lymphoma involvement
  • Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
  • History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent
LUNG CANCER: Brain metastases: XRT Device: \\\"METIS\\\"

Pivotal, open-label, randomized study of radiosurgery with or without tumor treating fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung Cancer; NSCLC, non-small cell lung cancer; brain metastases

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

NovoCure TTFields

Drug Class

Device administering alternating electrical fields

PI

Matt Ballo, M.D.

Sponsor

NovoCure Ltd.

Path

Non-small cell lung cancer. EGFR wt, ALK/ROS normal

Key Eligibility Criteria Details
  • New diagnosis of brain mets from a histologically or cytological confirmed primary or metastatic NSCLC tumor. If original histologic proof of malignancy is >5 years, new pathologic confirmation is needed
  • KPS >70
  • 1 inoperable brain mets or 2-10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to following criteria
    • Largest tumor volume < 10cc
    • Longest tumor diameter < 3cm
    • Cumulative volume of all tumors < 15cc
  • At least one measurable lesion per RANO-BM
  • May continue on systemic therapy during trial. Should be receiving optimal systemic therapy.
  • Patient must be able to operate NovoTTF-100M device independently or with caregiver
  • No ALK/ROS-1 alterations. No BRAF, EGFR mutations
  • No significant edema with risk of brain herniation
  • No midline shift > 10mm
  • No intractable seizures
  • No infratentorial or leptomeningeal mets
  • No recurrent brain mets or brain mets previously treated with surgery/XRT/radiosurgery
  • No implantable electronic medical devices in the brain
  • No other concurrent brain directed 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

VIEW TRIAL ON CLINICALTRIALS.GOV
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
SCLC: EXTENSIVE STAGE: 1st Line: Atezo +/- lurbinectidin: IMforte

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Small cell lung cancer, SCLC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line maintenance

Investigational Agent

lurbinectidin

Drug Class

alkylating agent

PI

Jason Porter, MD

Sponsor

Hoffmann La Roche

Path

small cell lung carcinoma

Key Eligibility Criteria Details
  • Eligibility for induction phase (Carbo etoposide)
    • Histologically or cytologically confirmed extensive stage SCLC
    • ECOG PS 0-1
    • No prior therapy for extensive stage disease
    • At least 6 monmths since chemo or XRT for earlier stage disease
    • Measurable disease
    • Negative for HIV and no known HBV/HCV
    • No CNS mets
    • No other malignancies within 5 years
  • Eligibilty for maintenance phase (atezolizumab +/- lurbinectidin)
    • Ongoing response or stable disease after 4 cycles of induction therapy
    • All toxicities attributed to prior induction therapy resolved to Grade
    • Not receiving consolidative chest radiation
    • Not receiving antibiotics at the time of randomization
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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: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.

VIEW TRIAL ON CLINICALTRIALS.GOV
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.

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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.
OVARIAN: METASTATIC: Plat Resistant: Chemo+/-Pembro: KEYNOTE-B96

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovary, Ovarian, Primary peritoneal, fallopian tube

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Michael Ulm

Sponsor

Merck Sharp and Dohme

Path

Epithelial Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • Has received 1 or 2 prior lines of systemic therapy, including at least 1 prior platinum-based therapy. 
  • Patients may have received prior PARPi, anti-PD-1/L1 or bevacizumab and these are not considered prior line of therapy
  • Radiographic evidence of disease progression within 6 months after the lat dose of platinum-based chemo
  • ECOG PS 0-1
  • Radiographically evaluable disease (measurable or non-measurable)
  • Cannot have primary platinum-refractory disease (defined as PD while actively receiving firstline platinum therapy)
  • Cannot have uncontrolled hypertenstion, clinically relevant bowel obstruction, or rectosigmoid involvement of cancer
  • Cannot have received more than 2 lines prior lines of systemic therapy
  • No known active CNS metastases
  • No known HIV/HBV/HCV
PROSTATE: 1st Line Chemo: Nivo+Taxotere: Checkmate 7DX

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate Cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Histologic confirmation of adenocarcinoma of the prostate without small cell features
  • Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue lesions on CT/MRI
  • ECOG PS 0-1
  • Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or bilateral orchiectomy
  • Documented disease progression per PCWG3 criteria within 6 months prior to screening
  • Only one prior 2nd generation hormonal therapy in the metastatic setting
    • Patients may have received two prior 2nd gen HT (abi + enza or apalutamide or darolutamide) if and only if the first drug had been used in the non-metastatic setting
  • Chemotherapy naive for metastatic CRPC
  • Must have progressed during or after 2nd gen hormonal therapy or have documented intolerance to 2nd gen HT
  • No active brain mets
  • No known or suspected autoimmune disease
  • No condition requiring systemic corticosteroids (>10 mg prednisone or equivalent)
  • No prior treatment with PD-1 or PD-L1 antibodies
  •  
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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.
SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

PI

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Path

Any

Key Eligibility Criteria Details
  • Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
    • CDK4/6 inhibitors (abemaciclib), 
    • PI3 kinase blockers (alpelisib),
    • anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib) 
    • anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
    • anti ALK TKIs (ceritinib, crizotinib)
    • MEK inhibitor (cobimetinib) 
    • Anti HER2 TKIs (lapatinib, tucatinib)
  • ECOG PS 0-2
  • Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
  • No diarrhea before enrolling on the study (or starting TKI)
  • No ongoing IBS or colitis
  • Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
  • No laxative use within 7 days prior to randomization
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

 

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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: 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: RCC, Breast, Prostate, Bladder, CRC: STELLAR-001

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Renal cell carcinoma, hormone receptor positive breast cancer, castration-resistant prostate cancer, urothelial cancer, colorectal cancer (HR+ BC, RCC, CRPC, Bladder, CRC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Generally at least 1 prior line. Some exceptions

Investigational Agent

XL092

Drug Class

VEGF/MET kinase inhibitor

PI

Dan Vaena, MD

Sponsor

Exelixis

Path

Key Eligibility Criteria Details
  • Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
  • Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum who received prior fluoropyrimidine-containing chemotherapy with oxaliplatin and irinotecan.
    • KRAS/NRAS wild type
    • Must have received all of the following: fluropyridmidine, irinotecan,  oxaliplatin,  EGFR monoclonal antibody, and, for those with BRAF mutation, BRAF inhibitor in combination with cetuximab
    • Must have progression during or within 3 months following the last dose of the most recent regimen
    • Prior therapy with regorafenib or TAS-102 are NOT allowed
  • Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who received first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin.
  • Expansion Cohort J (UC, ICI-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after PD-1/PD-L1 targeting ICI therapy.
  • Expansion Cohort K (UC, platinum-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after first-line platinum-based combination therapy.
  •  Locally advanced, recurrent, or metastatic
  • No known untreated CNS mets
  • ECOG PS 0-1
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: LATE LINE: GLOBO-H POSITIVE: OBI-999-001

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Pancreatic, Esophageal, Gastric, Colorectal, Breast, Lung, Prostate, Melanoma, Head and Neck, Sarcoma, Bladder, Renal Cell, Ovarian, Endometrial, Cervical

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-999

Drug Class

Globo H targeting agent

PI

Dan Vaena, MD

Sponsor

OBI Pharma

Path

Any solid tumor

Key Eligibility Criteria Details
  • Histologically or cytologicall confirmed patients with advanced solid tumors
  • Must have documented Globo H score of at least 100 from a qualified laboratory IHC assay
  • Must have been treated with established standard-f-care therapy or physicians have determined that such established therapy is not sufficiently efficacious or patients have declined to received standard-of-care therapy
  • ECOG PS 0-1
  • Measurable disease
  • Adequate organ function
  • No known untreated CNS mets
  • No significant clinical cardiac abnormality
ADVANCED SOLID TUMORS: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

PI

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
  • Must not be eligible for curative resection
  • Must be positive for at least 1 of the following human leukocyte antigens:
    • HLA-A*02:01
    • HLA-A*02:06
    • HLA-A*24:02
    • HLA-A*03:01
    • HLA-B*15:01
  • ECOG PS 0-1
  • No known CNS mets
  • No known HIV/HBV/HCV
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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
METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, metastatic solid malignancy
  • Has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior PD-1/PD-L1 allowed
  • No other malignancy within 2 years prior
  • No active autoimmune disease requiring systemic therapy within last 2 years
  • No chronic steroids or immunosuppressants.
X