Clinical Trial: NCT02861573
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-07-13 |
Study Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.
Official Title
Conditions
Intervention / Treatment
- Biological: Pembrolizumab 200 mg
- Drug: Olaparib 400 mg
- Drug: Docetaxel 75 mg/m^2
- Drug: Prednisone 5 mg
- Drug: Enzalutamide 160 mg
- Other: Dexamethasone 8 mg
- Drug: Olaparib 300 mg
- Drug: Abiraterone acetate 1000 mg
- Drug: Lenvatinib
- Biological: Pembrolizumab/Vibostolimab coformulation
- Drug: Carboplatin
- Drug: Etoposide
- Biological: Belzutifan 120mg
Other Study ID Numbers
- 3475-365
- KEYNOTE-365
- MK-3475-365
- 2023-506987-15-00
- U1111-1294-7577
- 2016-002312-41
- 2016
- 2023
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-07-13 |
Study Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.
Official Title
Conditions
Intervention / Treatment
- Biological: Pembrolizumab 200 mg
- Drug: Olaparib 400 mg
- Drug: Docetaxel 75 mg/m^2
- Drug: Prednisone 5 mg
- Drug: Enzalutamide 160 mg
- Other: Dexamethasone 8 mg
- Drug: Olaparib 300 mg
- Drug: Abiraterone acetate 1000 mg
- Drug: Lenvatinib
- Biological: Pembrolizumab/Vibostolimab coformulation
- Drug: Carboplatin
- Drug: Etoposide
- Biological: Belzutifan 120mg
Other Study ID Numbers
- 3475-365
- KEYNOTE-365
- MK-3475-365
- 2023-506987-15-00
- U1111-1294-7577
- 2016-002312-41
- 2016
- 2023