OncoMatch/Clinical Trials/NCT04071236
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
Is NCT04071236 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Avelumab and Peposertib for metastatic castration-resistant prostate carcinoma.
Treatment: Avelumab · Peposertib — This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Tumor Agnostic
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor inhibitor or taxane chemotherapy (abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel)
Progression after at least one of the following: abiraterone, enzalutamide, apalutamide, darolutamide, or taxane chemotherapy (docetaxel, cabazitaxel)
Cannot have received: chemotherapy or radiotherapy
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Cannot have received: hemibody external radiation
Patients who have had previous hemibody external radiation
Lab requirements
Blood counts
Albumin > 2.5 mg/dL; Hemoglobin > 9 g/dL; Leukocytes >= 3,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine <= 1.5 x institutional ULN OR GFR >= 40 mL/min/1.73 m^2
Liver function
Total bilirubin <= 1.5 x institutional ULN (with the exception of < 3 mg/dL for patients with Gilbert's disease); AST/ALT <= 3 x institutional ULN
Cardiac function
NYHA class 2B or better if cardiac disease or prior cardiotoxic agents
Albumin > 2.5 mg/dL; Hemoglobin > 9 g/dL; Leukocytes >= 3,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Total bilirubin <= 1.5 x institutional ULN (with the exception of < 3 mg/dL for patients with Gilbert's disease); AST/ALT <= 3 x institutional ULN; Creatinine <= 1.5 x institutional ULN OR GFR >= 40 mL/min/1.73 m^2; NYHA class 2B or better if cardiac disease or prior cardiotoxic agents
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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