Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase I and Randomized Phase II Trial of Radium-223 dichloride, M3814, & Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2020-092
    NCT ID
    • NCT04071236
    Age Group
    • Adult
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator


    Primary Objectives
    Phase 1:
    • To determine the maximum tolerated dose (MTD) of M3814 in combination with radium-223 dichloride or in combination with radium223 dichloride and avelumab in patients with advanced metastatic castrate-resistant prostate cancer (mCRPC) based on dose limiting toxicities (DLTs) in the doublet or triplet combinations.
    Phase 2:
    • Radiographic progression free survival (rPFS) will be evaluated based on both skeletal and extra-skeletal progression following PCWG3 methodology (Scher et al., 2016).
    Secondary Objectives
    • To determine the time to the first symptomatic skeletal event [SSE].
    • To determine the safety of radium223 dichloride, M3814, and avelumab combination treatment.
    • To observe and record anti-tumor activity. Although the clinical benefit of these drugs have not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
    • To evaluate progression free survival (PFS) and overall survival (OS).
    • To evaluate symptomatic skeletal events (SSE) per standardized Case Report Form (CRF) distinguishing between pathologic and non-pathogenic fractures.
    • To explore patient-reported symptomatic adverse events (AE) for tolerability of each treatment arm.
    • To examine the radium-223 dichloride bio-distribution and absorbed dose in each bone metastatic lesions as well as elsewhere in the body including critical organs using dosimetry.
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