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

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

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avelumab — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Peposertib — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies
• Radium Ra 223 Dichloride — RADIATION
  Given IV

Study Details

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.

Key Dates

First listed

Aug 28, 2019

Start date

Oct 14, 2020

Status verified

Jun 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (radium-223 dichloride)
  Patients receive radium-223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, and CT or MRI throughout the study.
• Active Comparator: Arm B (radium-223 dichloride, nedisertib)
  Patients receive radium-223 dichloride as in Arm A and peposertib PO or BID on days 3-26. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, and CT or MRI throughout the study.
• Experimental: Arm C (radium-223 dichloride, nedisertib, avelumab)
  Patients receive radium-223 dichloride IV as in Arm A and peposertib PO QD or BID as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 15 of cycles 2-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, and CT or MRI throughout the study.

Primary Outcome Measure

Dose-limiting toxicity (Phase 1) [ Time Frame: Up to 28 days ]

Locations (32)

Find similar trials in Duarte, CA

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