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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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 217 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Trial status changed: Suspended → Active, Not Recruiting
  3. Re-verified, no change to tracked fields
  4. Re-verified, no change to tracked fields
  5. Sponsor's reason: Other - To assess the study's feasibility. to Other - To assess the study's feasibility. Site details revised at 9 of 32 sites Show 1 more changeShow less
    • Site details revised at 9 of 32 sites
  6. Re-verified, no change to tracked fieldsv212
  7. Recruitment suspended Sponsor's reason: Other - To assess the study's feasibility. Site details revised at 32 of 32 sitesv211 Show 1 more changeShow less
    • Site details revised at 32 of 32 sites
  8. 2 versions Re-verified since Jun 10, 2026, no change to tracked fieldsv209-v210
  9. Site details revised at 2 of 32 sitesv208
  10. Re-verified, no change to tracked fieldsv207
  11. Primary and study completion pushed from Apr 30, 2026 to Apr 30, 2027v206
  12. Study Status, Contacts/Locationsv205
  13. 37 versions Re-verified since Feb 18, 2026, no change to tracked fieldsv168-v204
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04071236
Lead Sponsor National Cancer Institute (NCI)
Conditions Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lymph Nodes, Stage IVB Prostate Cancer AJCC v8
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov