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Androgen Synthesis Inhibitor

Pembrolizumab Combination Therapies for Prostate Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Cohorts F, H, I: Has t-NE or de novo metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment. Epstein criteria of neuroendocrine differentiation in prostate cancer is used for eligibility. Specimens must have one of the morphologies of Small cell carcinoma or Large cell neuroendocrine carcinoma (LCNEC) or Mixed (small or large cell) NE carcinoma - acinar adenocarcinoma with positive IHC confirmed by central pathology review
Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
Must not have
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 weeks over the duration of the study which is estimated to be approximately 2 years
Awards & highlights

Summary

This trial will assess the safety and efficacy of pembrolizumab in combination with other drugs for treating patients with mCRPC. There will be nine cohorts in the study, each receiving different combinations of drugs. Outcome measures will be assessed individually for each cohort.

Who is the study for?
Men with advanced prostate cancer that's resistant to hormone therapy and has spread, who are still undergoing androgen deprivation (testosterone <50 ng/dL). They must be relatively healthy (ECOG 0-2), able to provide a recent tumor sample, and have had cancer progression within the last 6 months. Participants should agree to contraception if applicable. Those with certain prior treatments or medical conditions like HIV, hepatitis B/C, brain metastases, or intense bone scans aren't eligible.Check my eligibility
What is being tested?
The trial is testing how safe and effective pembrolizumab is when combined with other drugs in different groups of patients with metastatic castration-resistant prostate cancer. There are ten cohorts each receiving various combinations including pembrolizumab plus olaparib, docetaxel/prednisone, enzalutamide, abiraterone/prednisone among others.See study design
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects such as inflammation in organs like lungs or intestines; skin reactions; hormonal gland problems; fatigue; infusion reactions; liver issues. Other drugs used may add side effects like nausea, hair loss from chemotherapy or blood clots from hormone therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer biopsy shows specific cell types and has been confirmed by a central review.
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My prostate cancer has worsened in the last 6 months, shown by tests or scans.
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I agree to follow the study's rules for sex and contraception during and after treatment.
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My prostate cancer is confirmed and not of the small cell type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lung inflammation that needed steroids or have it now.
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I have not received a live vaccine in the last 30 days.
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I have had a seizure in the last 6 months or am on seizure medication that affects liver enzymes.
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I have severe heart issues like heart failure, unstable chest pain, irregular heartbeat, or high blood pressure.
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I have fluid buildup in my abdomen or around my lungs.
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I have active diverticulitis or other serious abdominal conditions.
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I have not been in a pembrolizumab trial or received PD-1/PD-L1/PD-L2 inhibitors.
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I have been diagnosed with HIV.
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I have or might have cancer spread to my brain or its coverings.
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My blood pressure is either below 86 or above 170/105 mmHg.
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I have serious heart issues, including a recent heart attack or severe angina.
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I have a long-term liver disease.
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My heart's pumping ability is below the normal range.
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I have a condition that affects how my body absorbs medication.
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I had major surgery less than 3 weeks before starting the study treatment.
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I have a severe fistula.
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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.
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I have not had certain cancer treatments or recovered from their side effects in the last 2 weeks.
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I have been treated for an autoimmune disease in the last 2 years.
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I am currently taking medication that strongly affects liver enzyme levels.
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I haven't had major heart problems or strokes in the last year.
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I have coughed up bright red blood recently.
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I have been treated for prostate cancer with platinum-based drugs.
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I am currently taking medications that strongly affect liver enzymes.
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I am currently taking medication for fungus, certain antibiotics, or HIV/AIDS.
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My blood pressure is very high and not under control.
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I have had a transplant of an organ, bone marrow, or solid tissue.
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I have myelodysplastic syndrome.
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My bone scan shows intense activity that makes it hard to see future metastases.
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I stopped taking abiraterone acetate because of side effects.
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I have cancer that has spread to my brain or surrounding membranes.
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I have received radiopharmaceuticals for prostate cancer within the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 weeks over the duration of the study which is estimated to be approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 weeks over the duration of the study which is estimated to be approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Discontinuing Study Drug Due to AEs
Number of Participants with Adverse Events (AEs)
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
+1 more
Secondary outcome measures
Composite Response Rate Defined as Any One of the Following: A. Response Based on RECIST 1.1; B. PSA Decrease of ≥50%; or C. Circulating Tumor-cell Count Conversion (Pembrolizumab + Olaparib Cohort Only)
Disease Control Rate (DCR) Based on Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 Assessed by BICR
Duration of Response (DOR) Based on PCWG3-modified RECIST 1.1 Assessed by BICR
+4 more

Trial Design

12Treatment groups
Experimental Treatment
Group I: Pembrolizumab/Vibostolimab coformulation:t-NEExperimental Treatment1 Intervention
Participants with t-NE mCRPC in Cohort H will receive a coformulation fixed dose combination of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684) Q3W IV from Day 1 of Cycle 1. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.
Group II: Pembrolizumab/Vibostolimab coformulationExperimental Treatment1 Intervention
Participants with AC mCRPC in Cohort G will receive a coformulation fixed dose combination of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684) Q3W IV from Day 1 of Cycle 1. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.
Group III: Pembrolizumab+OlaparibExperimental Treatment3 Interventions
Participants with adenocarcinoma (AC) mCRPC in Cohort A will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week dosing cycle (Q3W) and olaparib 400 mg capsules or 300 mg tablets by mouth (PO) twice a day (BID) continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue until progression or a maximum of 35 treatment cycles (up to 2 years). Treatment with olaparib will continue until progression. Participants who must discontinue 1 of the 2 drugs in the combination due to adverse events may continue the study with the other combination drug.
Group IV: Pembrolizumab+Lenvatinib:t-NEExperimental Treatment2 Interventions
Participants with neuroendocrine (t-NE) mCRPC in Cohort F will receive pembrolizumab 200 mg IV on Day 1 Q3W, and lenvatinib 20 mg PO QD continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.
Group V: Pembrolizumab+Lenvatinib: ACExperimental Treatment2 Interventions
Participants with AC mCRPC in Cohort E will receive pembrolizumab 200 mg IV on Day 1 Q3W, and lenvatinib 20 mg PO QD continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.
Group VI: Pembrolizumab+EnzalutamideExperimental Treatment2 Interventions
Participants with AC mCRPC in Cohort C will receive pembrolizumab 200 mg IV on Day 1 Q3W and enzalutamide 160 mg PO every day (QD) continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue until progression or a maximum of 35 treatment cycles (up to 2 years). Treatment with enzalutamide will continue until progression. Participants who must discontinue 1 of the 2 drugs in the combination due to adverse events may continue the study with the other combination drug.
Group VII: Pembrolizumab+Docetaxel+PrednisoneExperimental Treatment4 Interventions
Participants with AC mCRPC in Cohort B will receive pembrolizumab 200 mg IV on Day 1 Q3W, docetaxel 75 mg/m^2 IV on Day 1 Q3W, and prednisone 5 mg tablet PO BID continuously from Day 1 of Cycle 1. Participants will only be permitted to receive a maximum of 10 cycles of docetaxel and prednisone. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.
Group VIII: Pembrolizumab+Carboplatin+EtoposideExperimental Treatment3 Interventions
Participants with neuroendocrine mCRPC in Cohort I Arm 1 will receive pembrolizumab 200 mg IV on Day 1 Q3W + carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 Q3W + etoposide 100 mg/m^2 IV on Days 1, 2, and 3 Q3W. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Treatment with carboplatin+etoposide will continue for a maximum of 4 cycles (up to 2.8 months). Participants who must discontinue 1 or 2 of the 3 drugs due to adverse events in the combination may continue the study with the other combination drug/drugs.
Group IX: Pembrolizumab+BelzutifanExperimental Treatment2 Interventions
Participants with AC mCRPC in Cohort J will receive belzutifan 120mg QD in the initial cohort. If an efficacy signal is detected in this arm based on a totality of evidence, Cohort J may be expanded further where participants will be randomized 1:1 to receive either belzutifan 120 mg QD or belzutifan 120 mg QD and pembrolizumab 200 mg Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.
Group X: Pembrolizumab+Abiraterone+PrednisoneExperimental Treatment3 Interventions
Participants with AC mCRPC in Cohort D will receive pembrolizumab 200 mg IV on Day 1 Q3W, abiraterone acetate 1000 mg PO QD and prednisone 5 mg tablet PO BID continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.
Group XI: Carboplatin+EtoposideExperimental Treatment2 Interventions
Participants with neuroendocrine mCRPC in Cohort I Arm 2 will receive carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 Q3W + etoposide 100 mg/m^2 IV on Days 1, 2, and 3 Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression. Treatment with carboplatin+etoposide will continue for a maximum of 4 cycles (up to 2.8 months). Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.
Group XII: BelzutifanExperimental Treatment1 Intervention
Participants with AC mCRPC in Cohort J will receive belzutifan 120mg QD in the initial cohort. If an efficacy signal is detected in this arm based on a totality of evidence, Cohort J may be expanded further where participants will be randomized 1:1 to receive either belzutifan 120 mg QD or belzutifan 120 mg QD and pembrolizumab 200 mg Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Prednisone 5 mg
2012
Completed Phase 3
~570
Lenvatinib
2020
Completed Phase 4
~2650
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab 200 mg
2013
Completed Phase 3
~930

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments include hormone therapy, chemotherapy, and immune checkpoint inhibitors like pembrolizumab. Hormone therapy reduces androgen levels or blocks their effects, slowing cancer growth. Chemotherapy uses drugs to kill rapidly dividing cells. Immune checkpoint inhibitors, such as pembrolizumab, block the PD-1 receptor on T-cells, enhancing the immune system's ability to attack cancer cells. These treatments are crucial as they offer different mechanisms to control or eliminate cancer, providing options tailored to individual patient needs and improving outcomes.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,812 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,063 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,398 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,130 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (Androgen Synthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02861573 — Phase 1 & 2
Prostate Cancer Research Study Groups: Pembrolizumab+Olaparib, Pembrolizumab/Vibostolimab coformulation, Pembrolizumab/Vibostolimab coformulation:t-NE, Pembrolizumab+Docetaxel+Prednisone, Pembrolizumab+Carboplatin+Etoposide, Pembrolizumab+Abiraterone+Prednisone, Pembrolizumab+Lenvatinib: AC, Carboplatin+Etoposide, Pembrolizumab+Enzalutamide, Pembrolizumab+Lenvatinib:t-NE, Belzutifan, Pembrolizumab+Belzutifan
Prostate Cancer Clinical Trial 2023: Abiraterone acetate Highlights & Side Effects. Trial Name: NCT02861573 — Phase 1 & 2
Abiraterone acetate (Androgen Synthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02861573 — Phase 1 & 2
~348 spots leftby Oct 2027
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