Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor inhibitor (ARI) is more effective against prostate cancer than pembrolizumab + ARI alone.

Trial Details

NCT ID
NCT04946370
Phase
PHASE1 / PHASE2
Sponsor
Weill Medical College of Cornell University
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • 225Ac-J591
  • Pembrolizumab
  • Androgen receptor inhibitor
  • 68Ga-PSMA-11
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Brooklyn, New York, United States|40.6501,-73.94958
  • New York, New York, United States|40.71427,-74.00597
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate adeno…
  • A male participant must agree to use a contraception during the treatment period and for at least 4 months after the last dose of study treatment a…
  • Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following crit…
  • Evaluable for response with at least one of the following:

For full eligibility, visit ClinicalTrials.gov.

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