Pembrolizumab for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you must continue taking enzalutamide and LHRH therapy. Some medications, like denosumab, are prohibited, and you should not have had certain treatments like chemotherapy or monoclonal antibodies recently. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for prostate cancer?
Pembrolizumab has shown some antitumor activity in prostate cancer, particularly in patients with specific genetic markers or PD-L1 expression. In a study, some patients with prostate cancer who were resistant to other treatments experienced significant reductions in prostate-specific antigen (PSA) levels, indicating a positive response to pembrolizumab.12345
Is pembrolizumab safe for humans?
Pembrolizumab has been used in various cancer treatments and is generally considered safe, but it can cause immune-related side effects. Some patients have experienced issues like muscle inflammation, thyroid problems, and a rare form of diabetes. These side effects are not common, but they can occur.12346
How is the drug pembrolizumab unique for treating prostate cancer?
Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. This mechanism is different from traditional treatments like hormone therapy or chemotherapy, which directly target cancer cells.12378
What is the purpose of this trial?
This phase II trial studies how well pembrolizumab works in treating patients with prostate cancer that has spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels despite previous treatment with enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.
Research Team
Julie Graff, M.D.
Principal Investigator
OHSU Knight Cancer Institute
Eligibility Criteria
This trial is for men with prostate cancer that has spread and doesn't respond to low testosterone or enzalutamide treatment. They must have good blood counts, liver and kidney function, be willing to use contraception, and not have had certain other treatments recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Patients receive pembrolizumab IV over 30 minutes on day 1, repeating every 3 weeks for 4 courses, alongside standard of care enzalutamide
Monitoring
Patients continue to receive standard of care enzalutamide daily for the duration of the trial
Retreatment
Patients with disease response or stability receive pembrolizumab IV over 30 minutes on day 1, repeating every 3 weeks for an additional 4 courses, alongside standard of care enzalutamide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Collins Medical Trust
Collaborator
Oregon Health and Science University
Collaborator
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University