Study on Pembrolizumab Combination Therapies for Advanced Prostate Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT02861573
This clinical trial is exploring the safety and effectiveness of different combinations of the drug pembrolizumab with other treatments for men with advanced prostate cancer that has spread and is resistant to hormone therapy.
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Program Overview
The study aims to test various combinations of pembrolizumab with other drugs to see how well they work in treating metastatic castration-resistant prostate cancer (mCRPC). Participants will be divided into different groups, each receiving a specific combination of treatments. The study will evaluate the outcomes for each group separately.
Description
This study involves several groups, each receiving a different combination of pembrolizumab with other medications. The goal is to find out which combinations are safe and effective for treating advanced prostate cancer that has spread and is resistant to hormone therapy. Participants may be eligible for a second round of treatment if they meet certain criteria after the first round. Enrollment for some groups has been closed, but the study continues to assess the remaining groups.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed advanced prostate cancer without small cell features.
- Must provide a tumor sample from a recent biopsy.
- Cancer must have progressed within 6 months before joining the study.
- Must be on ongoing hormone therapy to lower testosterone levels.
- Must be using bone-strengthening therapy if applicable.
- Must agree to use contraception during and after the study.
- Must have a performance status indicating ability to carry out daily activities.
- Specific prior treatments are required for certain groups.
Exclusion Criteria
- Recent treatment with certain cancer therapies or participation in other clinical trials.
- Active autoimmune diseases or recent use of immunosuppressive drugs.
- History of severe lung disease or other serious health conditions.
- Known infections like HIV or active hepatitis.
- Recent vaccination with live vaccines.
- Active brain metastases or certain bone scan results.
- Previous organ or bone marrow transplant.
- Specific health conditions or treatments that apply to certain groups.
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