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PROSTATE: METASTATIC: Castrate Sensitive: EvoPAR-PROSTATE01

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Saruparib

Drug Class

PARP inhibitor

PI

Brad Somer, MD

Sponsor

AstraZeneca

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Prostate adenocarcinoma which is de novo or recurrent and castrate sensitive
  • No small cell, neuroendocrine, sarcomatoid, spindle cell, or signet ring histology
  • Metastatic disease with clear evidence of at least 1 bone lesion and/or at least 1 soft tissue lesion that is assesable via CT or MRI
  • Receiving ADT with a GnRH analogue or has had bileteral orchiectomy
  • ECOG PS 0-1
  • Confirmed HRRm status by central tumor tissue and/or ctDNA test
  • No history of another primary malignancy (with some exceptions per protocol)
  • No spinal cord compression or brain mets unless asymptomatic and not requiring steroids
PROSTATE: METASTATIC: Castration Resistant: 2nd Line Hormonal: MK-5684-004

A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate Cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line Hormonal Therapy

Investigational Agent

MK-5684

Drug Class

CYP11A1 inhibitor

PI

Brad Somer, MD

Sponsor

Merck Sharp and Dohme

Path

Castration-Resistant

Key Eligibility Criteria Details
  • Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
  • Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
  • Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
  • Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or non metastatic hormone sensitive prostate cancer (nmHSPC), for at least 8 weeks (at least 14 weeks for participants with bone progression) Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
  • ECOG PS 0-1
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
  • Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
  • Has adequate organ function
  • Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
  • Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy are eligible
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • No presence of gastrointestinal condition
  • No history of pituitary dysfunction
  • No poorly controlled diabetes mellitus
  • No active or unstable cardio/cerebro-vascular disease, including thromboembolic events
  • Has not received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
  • Has not received prior treatment with radium for prostate cancer
  • Does not have a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • No known active central nervous system (CNS) metastases
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
Advanced Solid Tumors: Niraparib and Dostarlimab in HRD Solid Tumors

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

solid tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Niraparib and Dostarlimab

Drug Class

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

PI

Gregory Vidal, MD

Sponsor

West Cancer Center

Path

somatic HRD deficiency

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

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

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

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

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

Exclusion Criteria:

  1. Patients with the following malignancies will be excluded:

    • Prostate cancer
    • Ovarian, breast, and pancreatic patients with known germline BRCA1 or BRCA2 mutation
    • Platinum sensitive ovarian cancer (defined as recurrence > 6 months from last platinum agent), unless platinum intolerant.
ADVANCED SOLID TUMORS: Phase 1: 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
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