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Radiopharmaceutical

Radium-223 + M3814 + Avelumab for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Hiram A Gay

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, M3814, to see if it can help treat prostate cancer that has spread to other parts of the body and is no longer responsive to hormonal therapy. M3814 will be given alone or in combination with other drugs, and the goal is to see if it can lower the chances of the cancer growing or spreading.

Who is the study for?

This trial is for men aged 18+ with advanced prostate cancer that's spread and doesn't respond to hormonal therapy. They must have a life expectancy of at least 6 months, be on or willing to continue antiandrogen therapy, and have certain blood levels within specific ranges. HIV-positive patients can join if they're on effective treatment with an undetectable viral load.

What is being tested?

The study tests different combinations of treatments: radium-223 alone, radium-223 with M3814 (a cell growth blocker), or all three including avelumab (an immunotherapy). It aims to find the best dose and combination for treating metastatic castrate-resistant prostate cancer by comparing these approaches.

What are the potential side effects?

Potential side effects include typical reactions from radiation like nausea and fatigue, possible liver enzyme changes due to M3814, and immune-related effects such as inflammation in organs or infusion reactions from avelumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicity (Phase 1)

Radiographic progression free survival (rPFS) (Phase 2)

Secondary study objectives

Incidence of toxicity and adverse events

Overall survival (OS)

PFS

+1 more

Other study objectives

Biomarker analysis

Quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (radium-223 dichloride, nedisertib, avelumab)Experimental Treatment8 Interventions

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.

Group II: Arm A (radium-223 dichloride)Active Control6 Interventions

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.

Group III: Arm B (radium-223 dichloride, nedisertib)Active Control7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Biospecimen Collection

2004

Completed Phase 3

~2020