Radium-223 + Pembrolizumab for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This research study is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant prostate cancer.The interventions involved in this study are:* Radium-223* Pembrolizumab
Research Team
Atish Choudhury, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have had a biopsy confirming adenocarcinoma, show cancer progression, and have metastatic disease visible on bone scans. Participants need good organ function, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Radium-223 every 4 weeks and Pembrolizumab every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed up for overall survival
Treatment Details
Interventions
- Pembrolizumab
- Radium-223
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?
Dana-Farber Cancer Institute
Lead Sponsor
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