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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
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
Study 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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed every 3 weeks over the duration of the study which is estimated to be approximately 2 years
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
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 moreSecondary 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 moreTrial 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
Prednisone 5 mg
2012
Completed Phase 3
~570
Lenvatinib
2005
Completed Phase 4
~2690
Etoposide
2010
Completed Phase 3
~2440
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab 200 mg
2013
Completed Phase 3
~930
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,622 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,371 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,280 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation that needed steroids or have it now.I have not received a live vaccine in the last 30 days.I have had a seizure in the last 6 months or am on seizure medication that affects liver enzymes.I have severe heart issues like heart failure, unstable chest pain, irregular heartbeat, or high blood pressure.I have fluid buildup in my abdomen or around my lungs.I have active diverticulitis or other serious abdominal conditions.I have not been in a pembrolizumab trial or received PD-1/PD-L1/PD-L2 inhibitors.I have been diagnosed with HIV.I have a history of seizures or conditions that could lead to seizures.I have or might have cancer spread to my brain or its coverings.My blood pressure is either below 86 or above 170/105 mmHg.I have serious heart issues, including a recent heart attack or severe angina.I have a long-term liver disease.I am not taking medications like phenytoin or carbamazepine with my abiraterone treatment.My heart's pumping ability is below the normal range.My scans show my tumor is affecting a major blood vessel or has cavities.I have a condition that affects how my body absorbs medication.I had major surgery less than 3 weeks before starting the study treatment.I have a severe fistula.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.I have not had certain cancer treatments or recovered from their side effects in the last 2 weeks.I have been treated with docetaxel or another chemotherapy for my metastatic prostate cancer.I have been treated for an autoimmune disease in the last 2 years.I am currently taking medication that strongly affects liver enzyme levels.I have moderate to severe nerve pain or damage not caused by injury.I have severe heart failure symptoms.I have had chemotherapy for advanced prostate cancer but haven't taken abiraterone in the hormone-sensitive stage.I have taken medications like finasteride or estrogens in the last 4 weeks.I have been treated with ketoconazole for my prostate cancer for more than 7 days.I have atrial fibrillation or another heart rhythm problem that needs treatment.I haven't had major heart problems or strokes in the last year.I have been treated for prostate cancer with platinum-based drugs.My prostate cancer biopsy shows specific cell types and has been confirmed by a central review.I can provide a recent biopsy of my cancer that hasn't been radiated.My prostate cancer has worsened in the last 6 months, shown by tests or scans.I am currently on hormone therapy for prostate cancer with low testosterone levels.I have coughed up bright red blood recently.I have been on a stable dose of medication for bone health for at least 4 weeks.I agree to follow the study's rules for sex and contraception during and after treatment.I can care for myself and am up and about more than half of my waking hours.I have had docetaxel and possibly one other chemotherapy for advanced prostate cancer.I have taken abiraterone or enzalutamide for prostate cancer before chemotherapy and it didn't work or I couldn't tolerate it.I have mCRPC, haven't had chemo for it, may or may not have had second-gen hormone therapy, and if I did, it was only enzalutamide which I failed or couldn't tolerate. I could have had docetaxel or abiraterone before without issues.I have had docetaxel for my prostate cancer and possibly one other chemotherapy.I have had hormone therapy and up to 2 chemotherapies for my prostate cancer.My prostate cancer worsened after treatment with abiraterone.I have fluid buildup in my abdomen or around my lungs causing symptoms.I am currently taking medications that strongly affect liver enzymes.I am currently taking medication for fungus, certain antibiotics, or HIV/AIDS.My blood pressure is very high and not under control.I have had a transplant of an organ, bone marrow, or solid tissue.I have myelodysplastic syndrome.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My prostate cancer is confirmed and not of the small cell type.My bone scan shows intense activity that makes it hard to see future metastases.I have been treated with docetaxel or another chemotherapy for my metastatic prostate cancer.My prostate cancer got worse despite ketoconazole treatment.I stopped taking abiraterone acetate because of side effects.I took abiraterone for prostate cancer before chemotherapy and either it didn't work or I couldn't tolerate it.I have cancer that has spread to my brain or surrounding membranes.I have received radiopharmaceuticals for prostate cancer within the last 4 weeks.I have taken azole medication within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab+Olaparib
- Group 2: Pembrolizumab+Abiraterone+Prednisone
- Group 3: Pembrolizumab+Carboplatin+Etoposide
- Group 4: Pembrolizumab+Docetaxel+Prednisone
- Group 5: Pembrolizumab+Lenvatinib:t-NE
- Group 6: Carboplatin+Etoposide
- Group 7: Pembrolizumab+Lenvatinib: AC
- Group 8: Belzutifan
- Group 9: Pembrolizumab/Vibostolimab coformulation:t-NE
- Group 10: Pembrolizumab/Vibostolimab coformulation
- Group 11: Pembrolizumab+Enzalutamide
- Group 12: Pembrolizumab+Belzutifan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research facilities are conducting this trial?
"This clinical trial is based in several locations throughout America, including Call for Information (Investigational Site 0008) in Pittsburgh, Pennsylvania, Call for Information (Investigational Site 2038) in Louisville, Kentucky, and Call for Information (Investigational Site 2084) in San Francisco, California."
Answered by AI
What disease does the Pembrolizumab/Vibostolimab coformulation target?
"Pembrolizumab/Vibostolimab coformulation has been approved by the FDA to treat three different types of cancer: metastatic cutaneous squamous cell carcinoma, relapsing polychondritis, and melanoma."
Answered by AI
Are we able to sign up for this experiment at this time?
"That is correct, the listing on clinicaltrials.gov does show that this study is seeking participants. The trial was first established on November 17th, 2016 and has since been updated October 13th, 2022. They are looking for a total of 1000 patients at 19 different locations."
Answered by AI
How many people are going to be participating in this clinical trial?
"The sponsor, Merck Sharp & Dohme LLC, needs to enroll 1000 patients that meet the study's inclusion criteria. These participants will be recruited from different sites including Call for Information (Investigational Site 0008) in Pittsburgh, Pennsylvania and Call for Information (Investigational Site 2038) in Louisville, Kentucky."
Answered by AI
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