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BILIARY TRACT: METASTATIC: 1st Line: SWOG S1815

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

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Malignancy

Biliary Tract, cholangiocarcinoma, gallbladder cancer, bile duct cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

nab-paclitaxel

Drug Class

taxane

PI

Axel Grothey, MD

Sponsor

Southwest Oncology Group (SWOG)

Path

biliary carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer
  • Must have metastatic or unresectable disease and no prior therapy for metastatic disease
  • Does not need to be measurable disease
  • No ampullary cancer
  • No adjuvant therapy within 6 months prior to registration
  • ECOG PS 0-1
  • No other prior malignancy within 2 years
BILIARY TRACT: METASTATIC: 2nd Line: LEAP-005-Biliary

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Biliary Tract Cancer, Cholangiocarcinoma; Gallbladder cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Biliary Tract Cancer with 1 prior line of therapy
  • Adjuvant therapy only counts as prior line if recurrence within 6 months of completing tx
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
BLADDER: Metastatic: 1st line: Cisplatin Ineligible: HCRN GU15-215

A Randomized Phase II Trial of Atezolizumab With or Without Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer: Hoosier Cancer Research Network GU15-215

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Malignancy

Bladder, Transitional Cell, Ureter, Urethral, Renal Pelvis, Urothelial

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Atezolizumab and Bevacizumab

Drug Class

PD-L1 Antibody; VEGFR Antibody

PI

Dan Vaena, MD

Sponsor

Hoosier Cancer Research Network

Path

Transitional Cell Carcinoma

Key Eligibility Criteria Details
  • ECOG PS 0-2
  • Histological or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra
  • Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
  • Evaluable untreated tumor tissue for biomarker analysis.
  • Willing to undergo a core needle or excisional biopsy on-treatment.
  • Measurable disease
  • No prior chemotherapy for locally advanced or metastatic urothelial cancer
    • Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted
  • Ineligible for cisplatin as defined by presence of one or more of the following:
    • Impaired renal function [GFR ≥ 30 but ≤ 60 cc/min].
    • Grade ≥ 2 Hearing Loss (hearing loss measured by audiometry of 25 dB at two contiguous frequencies)
    • Grade ≥ 2 peripheral neuropathy
    • ECOG Performance Status of 2
    • Solitary Kidney
  • No Active or untreated central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
    • Evaluable or measurable disease outside the CNS
    • No metastases to midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
    • No history of intracranial or spinal cord hemorrhage
    • No evidence of significant vasogenic edema
    • No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose allowed
    • No stereotactic radiation, whole-brain radiation within 4 weeks prior to Cycle 1 Day 1
    • Patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy within 3 months prior to Cycle 1 Day 1 will be excluded
  • No malignancies other than urothelial cancer within 5 years prior
  • No history of autoimmune disease
  • Known HIV, HBV, or HCV
  • No inadequately controlled hypertension (defined as persistent systolic blood pressure (SBP) > 150 and/or diastolic blood pressure (DBP) > 100 mmHg)
BLADDER: METASTATIC: FIRST LINE: IMMUNOCHEMO COMB: NILE

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

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Malignancy

Bladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma, Ureter, Renal Pelvis

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Durvalumab, Tremelimumab

Drug Class

PD-L1 antibody, CTLA-4 antibody

PI

Dan Vaena, MD

Sponsor

AstraZeneca

Path

Transitional cell carcinoma

Key Eligibility Criteria Details
  • Unresectable or metastatic transitional cell carcinoma or the urothelium (renal pelvis, ureters, urinary bladder, or urethra)
    • Both transitional cell and mixed transitional/non-transitional cell histologies are permitted
  • No prior 1st line therapy for metastatic disease
    • Prior adjuvant therapy allowed if it has been >12 months since last therapy
    • Prior local intervesical chemo or immune therapy is allowed if at least 28 days before study treatment
  • Either cisplatin-eligible or cisplatin-ineligible but carboplatin eligible patients are allowed
  • Measurable disease
  • ECOG PS 0-1
  • No prior immunotherapy with exception of BCG or antitumor vaccines
  • No autoimmune disease requiring immunosuppression
  • No untreated CNS disease
  • No contraindications to platinum-based doublet chemotherapy
BREAST: NEOADJUVANT: ER+: Post-menopausal: DOD 16-1042

Randomized phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/HER2- breast cancer

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Malignancy

Breast cancer, Hormone receptor positive breast cancer, locally advanced BC

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Enzalutamide and fulvestrant

Drug Class

Androgen receptor inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

University of Colorado, Department of Defense

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • ER positive breast cancer
  • Tumor stage at least T2
  • Plan to receive local surgery
  • Post-menopausal or if premenopausal will need to have concurrent ovarian suppression
  • ECOG PS 0-2
  • No history of seizures
  • Not on full dose anticoagulation
  • No prior treatment with anti-androgen agents
  • No history of CNS metastases
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)

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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: Post-Mastectomy: Hypofractionated Radiotherapy: RT CHARM

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

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Malignancy

Breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Hypofractionated radiotherapy

Drug Class

Radiation

PI

Noam VanderWalde, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Invasive ductal, invasive lobular, tubular

Key Eligibility Criteria Details
  • Invasive breast cancer (ductal, lobular, tubular, mammary, medullary)
  • If received neoadjuvant therapy, pre treatment staging must have N1 or N2 disease pre-chemo or are T3N0
  • If did not receive neoadjuvant, must be T0N1-2a, T1N1-2a, T2N1-2a, or T3N0-2a.
  • No prior therapeutic radiation to the chest, neck, or axilla
  • No prior history of ipsilateral breast cancer
    • DCIS or LCIS are allowed
  • Negative margins following mastectomy
  • No significant post mastectomy complications in the ipsilateral breast requiring unplanned re-operation or admission for IV antibiotics.
    • Reoperation for margins or lymph node dissection is allowed
  • Radiation oncologist is NOT planning to use a chest wall/scar boost
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • No co-existing medical conditions with a life expectancy <5 years
  • ECOG PS 0-1
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; axillary dissection vs XRT; “Alliance-011202”

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

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Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

N/A

Drug Class

N/A

PI

Richard Fine, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Node-positive any histology

Key Eligibility Criteria Details
  • Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
  • No inflammatory breast cancer
  • No other malignancy within 5 years
  • Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
  • Must have documented ER/PR/HER2 status before neoadjuvant therapy
  • Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
  • Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
  • HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
  • Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
  • No neoadjuvant endocrine or radiation therapy
  • No history of prior breast cancer
  • ECOG PS 0-1
  • Must complete surgery within 56 days of finish of neoadjuvant therapy
  • At least 1 sentinel lymph node identified intra-operatively with at least micromets
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; standard vs comprehensive XRT; “NSABP B-51"
A randomized phase III clinical trial evaluating post-mastectomy chestwall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

regional nodal irradiation

Drug Class

N/A

PI

Noam VanderWalde, MD

Sponsor

NSABP Foundation

Path

Node positive prior to surgery, pathologically node negative at surgery

Key Eligibility Criteria Details
  • Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).  Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)

  • Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.

  • HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)

  • Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen

  • For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization

  • Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.

  • At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer

  • ECOG PS 0-1

BREAST: Metastatic: ER+, HER2neg, 1st line: BO41843

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

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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: TNBC: 2nd-3rd Line: LEAP-005-TNBC

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or 3rd line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

TNBC

Key Eligibility Criteria Details
  • Have received one or 2 prior lines of therapy
  • Must have been treated with taxane and antrhacycline in the past
  • Adjuvant/neoadjuvant tx not considered line of therapy unless progressed within 6 months
  • LDH <2.0 ULN
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
BREAST: METASTATIC: TNBC: PHASE 1: 2nd/3rd LINE: MK-5890-01-ARM2A

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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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 or 3rd line

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Must have measurable disease by RECIST 1.1
  • Diagnosis of TNBC
  • Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
  • Prior therapy should have included anthracycline and/or taxane
  • LDH must be <2x ULN at screening
  • May be PD-L1 treatment refractory (number capped)
  • ECOG PS 0-1
  • No 2nd malignancy within 2 years
  • No active CNS involvement
  • No history of interstitial lung disease
  • No active pneumonitis or history of non-infectious pneumonitis that required steroids
  • No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
  • No known HIV, HBV, HCV
  • No need for steroids at dose of greater than 10mg prednisone or equivalent daily
  • No recent history of substance abuse
BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: ESR1 mutant: SMX 18001

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation

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Malignancy

Breast cancer, invasive breast cancer, BC, hormone receptor positive BC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line or later endocrine tx

Investigational Agent

Lasofoxifene

Drug Class

SERM

PI

Lee Schwartzberg, MD

Sponsor

Sermonix Pharmaceuticals LLC

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • Postmenopausal women with locally advanced or metastatic breast cancer
  • Progression on an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor
  • Demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in metastatic setting)
  • Measurable or non-measurable disease allowed
  • One of the following ESR point mutations in cell-free DNA:
    • Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N
  • May have received up to one chemothearpy regimen in adjuvant or neoadjuvant setting
  • ECOG PS 0-1
  • No prior use of any SERM with following exception
    • OK if tamoxifen previously used in adjuvant setting with relapse at least 1 year after stopping tamoxifen
  • No prior everolimus or PI3K inhibitors
  • No presence of CNS disease
  • No immediate need for chemotherapy
  • No HIV, HBV, HCV
  • No prior malignancy in last 5 years except non-melanoma skin cancer or early stage cervical cancer
  • No uncontrolled HTN
  •  
BREAST: METASTATIC: TNBC: 1st Line: CONTESSA TRIO

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast cancer, triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Tesetaxel, nivolumab, pembrolizumab, atezolizumab

Drug Class

oral taxane, PD-1 or PD-L1 inhibitors

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • ER -, PR-, HER2 - biopsy proven breast cancer
  • Locally advanced (not curable by surgery or radiation) or metastatic
  • No prior chemotherapy for metastatic disease
  • (Neo)Adjuvant therapy allowed if disease free interval of at least 12 months after completion
  • No prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors
  • Tissue available for PD-1 level determination
  • ECOG PS 0-2
  • No known HIV/HBV/HCV
  • No history of active autoimmune disease
  • No Grade 2 or higher neuropathy
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
COLORECTAL: Metastatic: 1st Line Maintenance: LYNK-003

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

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Malignancy

Colon, Rectal, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Maintenance (after 1st Line)

Investigational Agent

Olaparib + Bevacizumab

Drug Class

PARP inhibitor

PI

Axel Grothey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Metastatic or unresectable colorectal adenocarcinoma
  • Has not progressed after first-line induction of at least 6 cycles of FOLFOX with bevacizumab
    • May have received prior adjuvant/neoadjuvant chemo for CRC as long as it was completed at least 6 months prior to initiation of metastatic FOLFOX-bev
  • Has experienced unacceptable toxicity to oxaliplatin that required the discontinuation of oxaliplatin (such as neurotoxicity)
  • Must be randomized within a minimum of 2 weeks and a maximum of 6 weeks after their last dose of FOLFOX+bev
  • ECOG PS 0-1
  • No known CNS disease
  • No known HIV/HBV/HCV
  • No clinically significant bleeding within 28 days
  • No uncontrolled hypertension, nephrotic syndrome, GI perforation
  • No prior tx with olaparib or other PARP inhibitor
COLORECTAL: Metastatic: 3rd Line: Post FOLFOX and FOLFIRI: LEAP 005-CRC

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Colon cancer, rectal cancer, colorectal cancer, CRC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Colorectal cancer that has received 2 prior lines of therapy
  • Participants must have received 5-FU (or capecitabine), oxaliplatin and irinotecan (FOLFOX and FOLFIRI)
  • Adjuvant therapy is considered prior line only if progression within 6 months following completion
  • Not MSI-h or dMMR
  • No prior FOLFOXIRI or FOLFIRINOX
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
Colorectal: Metastatic: 3rd Line or Later: U3-1402-A202

A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

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Malignancy

Colon cancer, Rectal Cancer, Colorectal Cancer, CRC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line or later

Investigational Agent

U3-1402

Drug Class

HER-3 directed ADC

PI

Axel Grothey, MD

Sponsor

Daiichi Sankyo, Inc.

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Pathological/histological confirmation of advanced or metastatic colon or rectal adenocarcinoma
  • Must be resistant, refractory, or intolerant to at least 2 prior lines of tx, that must include all of the following agents:
    • Fluoropyrimidine
    • Irinotecan
    • Platinum agents (oxaliplatin)
    • Anti EGFR agent if clinically indicated (RAS/BRAF wt)
    • Anti-VEGF agent (bevacizumab) unless contraindicated
    • IO therapy if clinically indicated (MSI-h)
  • MEasurable disease
  • ECOG PS 0-1
  • No history of interstitial lung disease
  • No severe pulmonary compromise
  • No steroids at >10mg prednisone daily or equivalent
  • No clinically active CNS disease
  • No prior treatment with anti-HER3 antibody or ADC containing topoisomerase I inhibitor
  • No other cancers within 3 years unless curatively treated
  • No known HBV/HCV
ENDOMETRIAL: METASTATIC: PHASE 1: 2nd/3rd LINE: MK-5890-001-ARM2B/C

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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Malignancy

Uterine, Endometrial

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd line

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Key Eligibility Criteria Details
  • Must have diagnosis of endometrial cancer
  • Must have received or been intolerant to no more than 2 prior lines of treatment
  • Prior treatment should have included platinum containing regimen
  • May be PD1 refractory (number capped)
  • ECOG PS 0-1
  • No 2nd malignancy within 2 years
  • No active CNS involvement
  • No history of interstitial lung disease
  • No active pneumonitis or history of non-infectious pneumonitis that required steroids
  • No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
  • No known HIV, HBV, HCV
  • No need for steroids at dose of greater than 10mg prednisone or equivalent daily
  • No recent history of substance abuse
ENDOMETRIAL: METASTATIC: 1st Line: DUO-E

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)

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Malignancy

Endometrial cancer, uterine cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line + maintenance

Investigational Agent

Durvalumab + olaparib

Drug Class

PD-L1 inhibitor, PARP inhibitor

PI

Adam ElNaggar, MD

Sponsor

AstraZeneca

Path

Epithelial endometrial carcinoma, carcinosarcoma

Key Eligibility Criteria Details
  • Female age 18 or greater
  • Histologicall confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcoma, are allowed
  • Disease in one of the following categories
    • Newly diagnosed Stage III disease (with measurable disease following surgery or biopsy)
    • Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
    • Recurrence of disease where the potential for cure by surgery alone or in combination is poor
  • Naive to first line systemic anti-cancer treatment.  For patients with recurrent disease only, prior chemo is allowed only if administered in the adjuvant setting and there is at least 12 months from the date of the last dose of chemo to the date of subsequent relapse
  • ECOG PS 0-1
  • No CNS disease
  • No prior treatment with PARP inhibitors or immunotherapy
GASTRIC: METASTATIC: 3rd Line: LEAP-005-Gastric

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Gastric adenocarcinoma, stomach cancer, Gastroesophageal junction cancer, GEJ cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Gastric cancer
  • Exactly 2 prior lines of therapy
  • Neoadj or adjuvant tx not considered prior line unless recurrence within 12 months  
  • Maintenance regimens are not considered lines of therapy
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1 - BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
GBM: 2nd Line: Pembro-Lenvatinib: LEAP-005-GBM

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Glioblastoma Multiforme, GBM, malignant glioma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

GBM

Key Eligibility Criteria Details
  • Histologically confirmed WHO Grade IV glioblastoma
  • Failed initial systemic tx
  • At least 3 weeks from prior surgical resection
  • At least 6 months from previous radiation unless new area of enhancement outside the 80% isodose line of originial radiation field
  • At least 6 weeks from prior mAbs
  • Has not required escalting doses of steroids or had progression of neurologic symptoms in last 2 weeks
  • No carcinomatous meningitis
  • No extracranial disease
  • No multifocal tumor
  • No recurrent tumor greater than 6cm
  • No intra- or pertumoral hemorrhage greater than grade 1
  • Measurable Disease per RECIST and RANO
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
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

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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
LUNG: NSCLC: METASTATIC: Non-squamous: 1st Line: LEAP-006

A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

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Malignancy

Lung cancer, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VGFR antibody, PD-1 antibody

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed metastatic nonsquamous NSCLC
  • EGFR wt, ALK-wt, ROS1-wt
  • Measurable disease per RECIST 1.1
  • ECOG PS 0-1
  • No prior PD-(L)1 therapy in adjuvant setting
  • First line metastatic:
    • Prior adjuvant therapy with radiation/surgery/chemo allowed if completed >6 months prior to relapse.
  • Adequately controlled BP defined as BP <150/90 with no change in antihypertensive meds within 1 week prior to randomization
  • No known untreated CNS mets
  • No history of pneumonitis that required steroids
  • No major blood vessel invastion or large volume hemoptysis
  • No known HIV/HBV/HCV
  • No active autoimmune disease
  • No prior hypersensitivity to monoclonal antibodies
LUNG: METASTATIC: PHASE 1: ADENOCA: 1ST LINE: MK-5890-001-ARM3

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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Malignancy

Lung cancer, non-squamous lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st Line (or 2nd line in rare cases)

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma

Key Eligibility Criteria Details
  • Histologically or cytologicall confirmed Stage IV (M1a or M1b) non-squamous NSCLC
    • Mixed histologies allowed if predominant type non-squamous
    • No small cell allowed (even if non-predominant part of mixed histology)
    • May be untreated or could have received 1 prior regimen
    • EGFR or ALK positive should have had prior treatment with TKI
  • No prior radiation therapy to the lung >30Gy within past 6 months
  • Must have measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No 2nd malignancy within 2 years
  • No active CNS involvement
  • No history of interstitial lung disease
  • No active pneumonitis or history of non-infectious pneumonitis that required steroids
  • No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
  • No known HIV, HBV, HCV
  • No need for steroids at dose of greater than 10mg prednisone or equivalent daily
  • No recent history of substance abuse
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)

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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
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: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.
MELANOMA: OCULAR MELANOMA: Metastatic: Hepatic dominant: Any line: \\\"FOCUS\\\"

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

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Malignancy

Melanoma, Ocular melanoma, hepatic metastases, skin

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Metastatic Any Line

Investigational Agent

Percutaneous hepatic perfusion of melphalan

Drug Class

Percutaneous hepatic perfusion

PI

Evan Glazer, MD

Sponsor

Delcath Systems Inc.

Path

Ocular melanoma

Key Eligibility Criteria Details
  • Histologically or cytologically proven ocular melanoma to the liver
  • No more than 50% liver parenchema involvement
  • Evidence of limited extrahepatic disease allowed as long as life threatening component of disease is in liver
  • ECOG PS 0-1
  • No Child Class B or C cirrhosis
  • No active HBV or HCV
  • No active CNS mets
OVARIAN: NEOADJUVANT: Intraperitoneal IL12 and chemo: OVATION 2

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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Malignancy

Ovarian, fallopian tube, primary peritoneal

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

GEN-1

Drug Class

IL-12 plasmid formulated with PEG-PEI-Cholesterol Lipopolymer

PI

Adam ElNaggar, MD

Sponsor

Celsion

Path

high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS

Key Eligibility Criteria Details
  • Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies (laparoscopic or percutaneous)
  • Histologic documentation of the original primary tumor is required
  • FIGO Stage III-IV
  • Following histologic subtypes eligible: high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS.
  • ECOG PS 0-2
  • No need for treatment with immunosuppressive medication
  • No patients receiving treatment for active autoimmune disease
  • No known CNS involvement
  • No prior abdominal radiation or chemotherapy for abdominal or pelvic tumor
OVARIAN: RECURRENT: PLATINUM RESISTANT: MOONSTONE

A phase 2 open-label, single-arm study to evaluate the efficacy and safety of the combination of niraparib and TSR-042 in patients with platinum-resistant ovarian cancer (MOONSTONE)

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Malignancy

Ovarian, Primary Peritoneal Cancer, Fallopian Tube

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd, 3rd, or 4th line

Investigational Agent

Niraparib and TSR-042

Drug Class

PARP inhibitor and PD-1 antibody

PI

Adam ElNaggar, MD

Sponsor

Tesaro, Inc.

Path

High grade serous, endometrioid, or clear cell

Key Eligibility Criteria Details
  • Recurrent high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer
  • Must be considered resistant to the last administered platinum therapy
  • Must be 2nd, 3rd, or 4th line
  • Must have been previously treated with platinu-based regimen, taxane, and bevacizumab
  • Measurable disease
  • ECOG PS 0-1
  • Did not have disease progression within 3 months of starting first-line platinum therapy
  • No known BRCA mutation
  • No prior therapy with PD-1 or PD-L1 agent
  • No known immunodeficiency or on steroids >10mg/day prednisone or equivalent
  • No uncontrolled CNS disease
  • No other cancers within 2 years
  • No known HIV, HBV, HCV
OVARIAN: 4th Line: Plat-Resistant: LEAP-005

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Ovarian, Primary Peritoneal Cancer, Fallopian Tube

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

4th line (not including maintenance therapies)

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Mer

Path

Ovarian carcinoma

Key Eligibility Criteria Details
  • Ovarian cancer with 3 prior lines of thearpy
  • Neoadjuvant/adjuvant IS considered prior line
  • Maintenance regimens regimens are NOT considered prior line
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
Pancreatic: Metastatic: 1st Line: NAPOLI 3

An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

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Malignancy

Pancreas Adenocarcinoma

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st

Investigational Agent

Irinotecan liposome injection (Nal-IRI)

Drug Class

Liposomal chemotherapy

PI

Axel Grothey, MD

Sponsor

Ipsen

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Histologically confirmed adenocarcinoma of pancreas not previously treated in metastatic setting
  • Initial diagnosis of metastatic disease < or = 6 weeks prior to screening
  • Measurable disease
  • ECOG PS 0-1
  • Adequate hepatic, hemtologic, and renal function
  • No prior therapy in adjuvant setting unless adjuvant therapy was completed at least 12 months prior to metastatic diagnosis
  • No CNS metastases
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

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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
  •  
RENAL CELL: METASTATIC: 2nd/3rd Line: MK-6482-013

Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma

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Malignancy

Renal cell carcinoma, Kidney cancer, clear cell, RCC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd, 3rd, or 4th

Investigational Agent

Belzutifan

Drug Class

HIF-2a inhibitor

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Clear cell component

Key Eligibility Criteria Details
  • Histologically confirmed diagnosis of locally advanced/metastatic RCC with clear cell component
  • Has had disease progression on or after having received 1st line systemic treatment for RCC with CTLA4+PD1 or VEGF-TKI+PD1
  • No more than 3 prior lines of therapy
  • KPS >/= 70
  • No requirement for supplemental oxygen at baseline
  • No prior cancer within 3 years
  • No known CNS mets
  • No significant cardiac disease
  • No receipt of GCSF or EPO within 28 days prior to first dose
  • No known HBV/HCV/HIV
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.
MOLECULARLY TARGETED: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

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Malignancy

Solid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Following all effecive therapy (late line)

Investigational Agent

Pemigatinib

Drug Class

FGFR inhibitor

PI

Dan Vaena, MD

Sponsor

Incyte Corporation

Path

FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation

Key Eligibility Criteria Details
  • Metastatic or surgically unresectable solid tumor
  • Measurable disease
  • Documentation of an FGFR1-3 gene mutation or translocation
  • At least 1 prior line of therapy with progression
  • No other therapy available likely to provide clinical benefit
  • ECOG PS 0-2
  • No other FGFR inhibitors within last 6 months
  • No clinically significant corneal or retinal disorder
  • No untreated CNS disease (except primary brain cancer)
  • No additional malignancy at current time requiring active treatment
  • No history of calcium or phosphate disorder or systemic mineral imbalance
  • No clinically significant cardiac disease
  • No active HBV/HCV
  • No known HIV
MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification

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Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Key Eligibility Criteria Details
  • Histologically confirmed cancer for which no curative therapy exists
  • Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
    • Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
  • At least one measurable or evaluable lesion
  • LVEF >/=50%
  • ECOG PS 0-2
  • No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
  • No symptomatic or unstable brain mets (stable are allowed)
  • No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
  • No uncontrolled cardiac disease
  • No chronic diarrheal disorder
ADVANCED SOLID TUMORS: Phase 1: PD1+LAG3+CTLA-4: 1st LINE: CA 224-048

A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

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Malignancy

Part 2A: Melanoma, Head and Neck. Part 2B: NSCLC (lung)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Relatlimab with nivolumab and ipilimumab or relatlimab with nivolumab and BMS-986205)

Drug Class

LAG-3 inhibitor with PD-1 inhibitor and either CTLA-4 inhibitor or IDO inhibitor

PI

Ari VanderWalde

Sponsor

Bristol-Myers Squibb

Path

Selected solid tumor types

Key Eligibility Criteria Details

Part 1:

  • Locally advanced or metastatic NSCLC, melanoma, SCCHN, RCC, or GC/GEJ cancer
    • NSCLC and SCCHN must have received prior platinum-based therapy
    • Patients with targetable mutations (e.g. ALK, ROS, EGFR, etc.) must have had prior treatment with approved targeted therapy
  • May have had prior therapy with anti-CTLA-4 or anti-PD-1/L1 therapy
  • Prior treatments limited to no more than 3
  • ECOG PS 0-1
  • LVEF 50% or higher
  • No known CNS mets
  • No history of pneumonitis
  • No prior cancer within 3 years (except locally curable cancers)
  • No history of life-threatening toxicity to immunotherapy
  • No known HBV/HCV/HIV
ADVANCED SOLID TUMORS: PHASE 1: OBI-888

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

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Malignancy

Colon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-888

Drug Class

Anti-globo-H antibody

PI

Axel Grothey, MD

Sponsor

OBI Pharma

Path

Globo-H overexpression

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed patients with advanced or metastatic solid tumors
  • Measurable disease
  • Must have been treated with all estrablished standard-of-care therapy or determined by the physician that such established therapy is not sufficiently efficacious, or patients have declined to receive standard of care therapy
  • ECOG PS 0-1
  • Must have Globo-H overexpression as measured by central lab
  • No known active autoimmune or inflammatory disease
  • Not receiving systemic steroids of >10mg prednisone per day or equivalent
ADVANCED SOLID TUMORS: PHASE 1: 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

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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: SCLC, GEJ, PDAC, Endometrial: PEN-866-001

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

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Malignancy

Anal cancer, Pancreatic cancer, PDAC, Cervix, cervical cancer, Gastric cancer, Gastroesophageal cancer, SCLC, Small cell lung cancer, penile, vulvar

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or later

Investigational Agent

PEN-866

Drug Class

HSP-90 inhibitor

PI

Dan Vaena, MD

Sponsor

Tarveda Therapeutics

Path

adenocarcinoma or squamous cell carcinoma

Key Eligibility Criteria Details
  • One of the following malignancies
    • Small cell lung cancer: locally recurrent or metastatic SCLC whose disease has progressed after at least 1 prior line of chemo
    • Gastric or GEJ adenoCA: Disease that has progressed after at least 1 prior line of chemo
    • SCC of genitalia (anus, cervix, vulva, or penis): disease that has progressed after at least 1 prior line (adjuvant counts as prior line)
    • Pancreatic CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
    • Endometrial CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
  • ECOG PS 0-1
  • Measurable disease
  • No prior topoisomerase I inhibitor
  • No symptomatic CNS involvement
  • No known HIV/HBV/HCV
ADVANCED TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

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Malignancy

Lung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any line as long as appropriate to give study acceptable chemo in combination

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

Key Eligibility Criteria Details
  • Advanced solid tumor or relapsed/refractory lymphoma OR
    • eligible to receive single agent pembrolizumab as standard-of-care OR
    • eligible to receive single-agent docetaxel as standard of care OR
      ​advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
  • Measurable disease
  • ECOG PS 0-1
  • No history of severe autoimmune disease
  • Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy
ADVANCED SOLID TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-002

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

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Malignancy

Prostate, Kidney, Head and Neck, Colon Rectum, Gastric, Esophagus

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

late line

Investigational Agent

TTX-030, budigalimab

Drug Class

Anti CD-39, anti-PD1

PI

Dan Vaena, MD

Sponsor

Tizona Therapeutics

Path

Any

Key Eligibility Criteria Details
  • Advanced Solid Malignancy
  • Fresh and/or archival tumor tissue
  • Evidence of measurable disease (except for prostate)
  • Life expectancy >12 weeks
  • ECOG PS 0-1
  • No therapeutic anticoagulation
  • no history of autoimmune disease
  • No uncontrolled intercurrent illness
  • No HTN >150/90 despite optimal management
  • No active CNS mets
  • No other malignancies within 3 years
  • No autoimmune toxicity >Grade 3 from prior immunotherapy
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
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.

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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.
ADVANCED TUMORS: PHASE 1 (ESCALATION): PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

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Malignancy

Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

BMS 986258

Drug Class

TIM-3 antibody

PI

Dan Vaena, MD

Sponsor

Bristol Myers Squibb

Path

Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • No active CNS disease (controlled brain mets are allowed)
  • Must have one of the five malignancies below
    • Clear-cell RCC
    • Triple-negative Breast Cancer
    • Squamous cell carcinoma of the head and neck
    • Colorectal cancer
    • Non-small cell lung cancer
  • No other malignancies within 2 years
  • No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
  • No severe autoimmune reactions to immunotherapy
  • No need for active steroid therapy
  • No significant cardiac disease
  • No chronic hepatitis
  • No active interstitial lung disease
  • RCC specific eligibility criteria
    • Previously received one or two anti-VEGFR therapies
    • No more than 3 total prior systemic tx in metastatic setting
    • Must have evidence of progression on or after last treatment received and within 6 months of starting study
  • CRC specific eligibilty criteria
    • Must have received and progressed on at least 1 standard therapy for metastatic disease
    • Must have known MSI status
  • NSCLC specific eligibility criteria
    • Must have progressed on or been refractory to platinum doublet
    • Must have known EGFR, ALK, ROS1 status.
      • Those with EGFR or ALK alterations must have previously received TKI therapy
  • SCCHN specific eligibility criteria
    • Not amenable ot local therapy with curative intent
    • Must have progressed on or been intolerant of platinum containing regimen
  • TNBC specific eligibility criteria
    • Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane
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