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NCT02861573 · ClinicalTrials.gov registry record · Phase 1
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT02861573 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, above the 181-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (563% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT02861573, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab 200 mg
- DRUG Olaparib 400 mg
- DRUG Docetaxel 75 mg/m^2
- DRUG Prednisone 5 mg
- DRUG Enzalutamide 160 mg
Study Locations (20)
Other
- MSD Australia - North Ryde
- MSD Denmark - Glostrup Municipality
- MSD France - Paris
- MSD Ireland (Human Health) Ltd. - Dublin
- MSD Italia S.r.l. - Rome
- MSD Comercializadora, S. de R.L. de C.V. - Mexico City
- Merck Sharp & Dohme BV - Haarlem
- Merck Sharp & Dohme (New Zealand) Ltd., - Auckland
- MSD Polska Sp. Z o.o. - Warsaw
- Merck Sharp and Dohme de Espana S.A. - Madrid
- MSD Sweden - Stockholm
- Merck Sharp & Dohme Ilaclari Ltd. Sti - Istanbul
Colorado
- Call for Information (Investigational Site 2041) - Aurora
Ohio
- Call for Information (Investigational Site 2091) - Cleveland
Oregon
- Call for Information (Investigational Site 2094) - Portland
Pennsylvania
- Call for Information (Investigational Site 0008) - Pittsburgh
South Carolina
- Call for Information (Investigational Site 0019) - Myrtle Beach
Tennessee
- Call for Information (Investigational Site 2090) - Germantown
Washington
- Call for Information (Investigational Site 0016) - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2016-11-17 |
| Est. Completion | 2028-07-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02861573
The ClinicalTrials.gov registry entry for NCT02861573 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (563% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab 200 mg is the first listed.
NCT02861573 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT02861573 about?
NCT02861573 is a clinical study titled "Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)". 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 p...
What is the current status of trial NCT02861573?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,200 participants. The study started on 2016-11-17. Estimated completion is 2028-07-24.
What conditions does trial NCT02861573 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT02861573?
The interventions under investigation include: Pembrolizumab 200 mg (BIOLOGICAL), Olaparib 400 mg (DRUG), Docetaxel 75 mg/m^2 (DRUG), Prednisone 5 mg (DRUG), Enzalutamide 160 mg (DRUG).
Who is sponsoring clinical trial NCT02861573?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02861573 being conducted?
This trial has 20 study locations across Colorado, Ohio, Oregon, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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