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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.GOVProstate Cancer
Stage 4
Phase 3
Open to Enrollment
2nd Line Hormonal Therapy
MK-5684
CYP11A1 inhibitor
Brad Somer, MD
Merck Sharp and Dohme
Castration-Resistant
A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature
VIEW TRIAL ON CLINICALTRIALS.GOVProstate, CRPC
Stage 4
Phase 3
Open to Enrollment
2nd line or later
Carboplatin
platinum chemotherapy
Dan Vaena, MD
SWOG
Adenocarcinoma
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
VIEW TRIAL ON CLINICALTRIALS.GOVProstate
Stage 4
Phase 2
Open to Enrollment
> or - 2nd line
Pembrolizumab, Lenvatinib
PD-1 inhibitor, VEG-F TKI
Dan Vaena, MD
Merck Sharp and Dohme
Prostate Adenocarcinoma without small cell histology
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
VIEW TRIAL ON CLINICALTRIALS.GOVProstate
Stage 4
Phase 2
Open to Enrollment
1st or later
Pemrbolizumab and Lenvatinib
PD-1 inhibitor, VEGF TKI
Dan Vaena, MD
Merck Sharp and Dohme
Neuroendocrine castration resistant prostate cancer
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
VIEW TRIAL ON CLINICALTRIALS.GOVProstate
Stage 4
Phase 2
Open to Enrollment
2nd line or greater
Pembrolizumab Vibostolimab coformulation
PD-1 inhibitor + Anti-TIGIT
Dan Vaena, MD
Merck Sharp and Dohme
Adenocarcinoma
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
VIEW TRIAL ON CLINICALTRIALS.GOVProstate
Stage 4
Phase 2
Open to Enrollment
Treated or de novo
Pembrolizumab, Carboplatin, Etoposide or Carbo/Etoposide alone
PD-1 inhibitor, chemo
Dan Vaena, MD
Merck Sharp and Dohme
Prostate cancer with neuroendocrine features
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
VIEW TRIAL ON CLINICALTRIALS.GOVProstate
Stage 4
Phase 2
Open to Enrollment
1st Line chemo or later
Pembrolizumab/Vibostolimab
PD-1/anti-TIGIT coformulation
Dan Vaena, MD
Merck Sharp and Dohme
Prostate Adenocarcinoma without small cell histology
An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors
VIEW TRIAL ON CLINICALTRIALS.GOVOvarian, Fallopian Tube, Prostate cancer, Pancreastic cancer, BRCA mutation
Stage 4
Phase 1
Open to Enrollment
Last line
XL309
USP1 inhibitor
Dan Vaena, MD
Exelixis
BRCA mt
i. Histologically confirmed locally advanced/metastatic HER2-negative breast cancer, with deleterious or suspected deleterious BRCA1/2 mutation, that progressed on, was intolerant to, was refused, or ineligible for (PARPi).
ii. Histologically confirmed locally advanced/metastatic HGSOC (high-grade serous ovarian cancer), including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC), that progressed on, was intolerant to, refused, or ineligible to maintenance treatment with a PARPi.
iii. Histologically confirmed locally advanced/metastatic CRPC, with deleterious or suspected deleterious BRCA1/2 mutation, that progressed on, was intolerant to, refused, or ineligible for PARPi.
iv. Histologically confirmed locally advanced/metastatic pancreatic cancer with deleterious or suspected deleterious BRCA1/2 mutation that progressed on, was intolerant to, refused, or ineligible for maintenance treatment with a PARPi.
v. Locally advanced/metastatic tumors with deleterious or suspected deleterious germline or somatic HRR mutation or HRD phenotype.
Cohort-Expansion Stage Single Agent and Combination:
b) HER2-negative BRCAm Breast cancer cohort: i. Histologically confirmed locally advanced/metastatic HER2-negative Breast cancer with deleterious or suspected deleterious BRCA1/2 mutation have documented radiographic disease progression during or following their last systemic anticancer therapy and that progressed on, was intolerant to, refused, or ineligible for treatment with a PARPi.
c) Platinum-resistant HGSOC cohort: i. Histologically confirmed locally advanced/metastatic HGSOC, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC), that progressed on, was intolerant to, refused, or ineligible to maintenance treatment with a PARPi and who have platinum-resistant disease, defined by platinum free interval of less than 6 months ii. Platinum-refractory disease (progression on first-line treatment or within 4 weeks of completion) are excluded.
d) Platinum-sensitive HGSOC cohort - expansion combination only: i. Histologically confirmed locally advanced/metastatic HGSOC, including PPC and FTC, that progressed on, refused, or ineligible to maintenance treatment with a PARPi, and who have platinum-sensitive disease, defined by platinum free interval of more than 6 months e) mCRPC cohort: i. Subjects with metastatic, castration-resistant adenocarcinoma of the prostate with deleterious or suspected deleterious BRCA1/2 mutation, that progressed on, or was intolerant, refused, or ineligible to PARPi.
f) HRRm advanced solid tumors cohort: i. Locally advanced/metastatic tumors with deleterious or suspected deleterious germline or somatic HRR mutation or HRD phenotype.
A Phase II Trial of Niraparib and Dostarlimab Combination Therapy in Patients
with Somatic Homologous Recombination Deficient Advanced or Metastatic
Cancer
solid tumors
Stage 4
Phase 2
Open to Enrollment
any
Niraparib and Dostarlimab
PARP inhibitor + IgG4 humanized monoclonal antibody resulting in PDL1/2 inhibition.
Gregory Vidal, MD
West Cancer Center
somatic HRD deficiency
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.
Participant must have adequate organ function, defined as follows:
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:
Patients with the following malignancies will be excluded:
A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 As Monotherapy and in Combination Therapy in Participants with Advanced Solid Malignancies
VIEW TRIAL ON CLINICALTRIALS.GOVAdvanced Solid Tumors: Breast, Lung, Colon, Prostate, Pancreatic, Gastric, Esophageal, HCC, Ovarian, Endometrial, Cervical, HNSCC, Head and Neck, Bladder, Sarcoma
Stage 4
Phase 1
Open to Enrollment
2nd line or later
COM503
Anti-IL18 blocking protein antibody
Dan Vaena, MD
Compugen
Any
Inclusion Criteria:
Exclusion Criteria:
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.GOVEsophageal, 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 4
Phase 1
Open to Enrollment
>1st line
RO7502175
Anti-CCR8 antibody
Dan Vaena, MD
Genentech, Inc.
Carcinoma