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

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 sys

Trial Details

NCT ID
NCT04071236
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Avelumab
  • Biospecimen Collection
  • Bone Scan
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Peposertib
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility Criteria

  • PHASE 1: Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
  • PHASE 2: ECOG performance status =\< 2 (Karnofsky \>= 60%)
  • Unless a patient has had orchiectomy by surgery, the patient is expected to be on antiandrogen therapy (ADT) for "medical castration". ADT needs to…
  • Progressive castration-resistant prostate cancer with two or more skeletal metastases identified by 99mTC bone scintigraphy. One or more lymph node…

For full eligibility, visit ClinicalTrials.gov.

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