RecruitingPhase 1Phase 2NCT02861573

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

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,200 participants

Start Date

Nov 17, 2016

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the immunotherapy drug pembrolizumab — which helps the immune system fight cancer — in combination with various other treatments for men with prostate cancer that has spread and no longer responds to hormone therapy, a condition called castration-resistant prostate cancer. **You may be eligible if...** - You have confirmed advanced prostate cancer that has stopped responding to hormone therapy - For most groups: your cancer is the standard glandular type (adenocarcinoma) - For specific groups: your cancer has neuroendocrine features, a less common more aggressive type - You have already tried at least one standard treatment for this stage of prostate cancer - You are in good enough health to participate **You may NOT be eligible if...** - You have small cell prostate cancer (for most groups) - You have a serious autoimmune disease - You are on high-dose steroids or immune-suppressing medications - You have active HIV, hepatitis B, or hepatitis C infection - You have recently had another type of cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab 200 mg

IV Q3W

DRUGOlaparib 400 mg

Eight 50-mg capsules PO BID

DRUGDocetaxel 75 mg/m^2

IV Q3W

DRUGPrednisone 5 mg

One 5-mg tablet PO BID

DRUGEnzalutamide 160 mg

Four 40-mg capsules, four 40-mg tablets, or two 80-mg tablets PO QD

OTHERDexamethasone 8 mg

Premedication for Cohort B given PO at 12, 3, and 1 hours prior to docetaxel infusion Q3W

DRUGOlaparib 300 mg

Two 150-mg tablets PO BID

DRUGAbiraterone acetate 1000 mg

Two 500-mg or four 250-mg tablets PO QD

DRUGLenvatinib

20 mg PO QD

BIOLOGICALPembrolizumab/Vibostolimab coformulation

IV Q3W

DRUGCarboplatin

IV Q3W

DRUGEtoposide

IV on Days 1, 2 and 3 of each cycle

BIOLOGICALBelzutifan 120mg

PO QD

Locations(21)

Call for Information (Investigational Site 2041)

Aurora, Colorado, United States

Call for Information (Investigational Site 2091)

Cleveland, Ohio, United States

Call for Information (Investigational Site 2094)

Portland, Oregon, United States

Call for Information (Investigational Site 0008)

Pittsburgh, Pennsylvania, United States

Call for Information (Investigational Site 0019)

Myrtle Beach, South Carolina, United States

Call for Information (Investigational Site 2090)

Germantown, Tennessee, United States

Call for Information (Investigational Site 0016)

Seattle, Washington, United States

MSD Australia

North Ryde, Australia

Merck Canada

Kirkland, Quebec, Canada

MSD Denmark

Glostrup Municipality, Denmark

MSD France

Paris, France

MSD Ireland (Human Health) Ltd.

Dublin, Ireland

MSD Italia S.r.l.

Rome, Italy

MSD Comercializadora, S. de R.L. de C.V.

Mexico City, Mexico

Merck Sharp & Dohme BV

Haarlem, Netherlands

Merck Sharp & Dohme (New Zealand) Ltd.,

Auckland, New Zealand

MSD Polska Sp. Z o.o.

Warsaw, Poland

Merck Sharp and Dohme de Espana S.A.

Madrid, Spain

MSD Sweden

Stockholm, Sweden

Merck Sharp & Dohme Ilaclari Ltd. Sti

Istanbul, Turkey (Türkiye)

Merck Sharp & Dohme Ltd.

London, United Kingdom

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NCT02861573

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