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RECRUITING Phase 1

Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

NCT02861573 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Merck Sharp & Dohme

741 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02861573 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Colorado, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02861573?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial