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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: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Merck Sharp & Dohme.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Metastatic Castration-Resistant Prostate Cancer

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

FieldValue
Enrollment Target 1,200 participants
Start Date 2016-11-17
Est. Completion 2028-07-24
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What NCT02861573 shows while recruiting

NCT02861573 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 181-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (563% higher).

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 names 20 study sites across 9 states, led by 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.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02861573's enrollment target sits among peer trials

1,200 2nd of 69 the highest of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT02861573

Source: ClinicalTrials.gov NCT02861573, the US trial registry maintained by the National Library of Medicine. NCT02861573 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.