Radium-223 + Pembrolizumab for Prostate Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: GnRH agonist

Must not be taking: Antidepressants, Immunosuppressants

Disqualifiers: Small cell carcinoma, Liver metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 223

Duration: 8 weeks

45 Participants Needed

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

Agreement to use adequate contraception

Ability to understand and sign informed consent document

My prostate cancer diagnosis was confirmed through a tissue examination.

Exclusion Criteria

I meet the specific health and treatment history criteria for the study.

I have previously received treatment with radium-223 or PD-1/PD-L1/PD-L2 blockers.

My prostate cancer is mainly small cell type.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Radium-223 every 4 weeks and Pembrolizumab every 3 weeks

8 weeks

Radium-223: 2 visits (in-person), Pembrolizumab: 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

22.4 months

Visits every cycle

Long-term follow-up

Participants are followed up for overall survival

36 months

Treatment Details

Interventions

• Pembrolizumab
• Radium-223

Trial Overview The trial is testing the combination of Radium-223 (a radioactive drug) with Pembrolizumab (an immunotherapy drug) for safety and effectiveness in treating castration-resistant prostate cancer that has spread to bones.

Participant Groups

Group I: Radium-223 Experimental Treatment 1 Intervention

- Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose

Group II: Pembrolizumab Plus Radium-223 Experimental Treatment 2 Interventions

* Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose * Pembrolizumab will be administered intravenously every 3 weeks at a pre-determined dose Radium-223 will be halted after 3 doses. Once radiographic progressive disease occurs, the last 3 doses of radium will be given.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• 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

Approved in European Union as KEYTRUDA for:

• 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

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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