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Pembrolizumab Combination Therapies for Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Pembrolizumab+Lenvatinib: AC
- Group 2: Pembrolizumab/Vibostolimab coformulation:t-NE
- Group 3: Pembrolizumab+Olaparib
- Group 4: Pembrolizumab/Vibostolimab coformulation
- Group 5: Pembrolizumab+Docetaxel+Prednisone
- Group 6: Pembrolizumab+Enzalutamide
- Group 7: Pembrolizumab+Carboplatin+Etoposide
- Group 8: Pembrolizumab+Abiraterone+Prednisone
- Group 9: Carboplatin+Etoposide
- Group 10: Pembrolizumab+Lenvatinib:t-NE
- Group 11: Belzutifan
- Group 12: Pembrolizumab+Belzutifan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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