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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04946370
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 225Ac-J591 — DRUG
    Alpha-emitter Actinium-225 conjugated to the anti-PSMA antibody J591.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered intravenously, 400mg every 6 weeks. Patients may receive maximum 18 cycles of therapy, approximately 2 years.
  • Androgen receptor inhibitor — DRUG
    Patients will receive an oral androgen receptor inhibitor (ARI). Examples include enzalutamide, apalutamide, darolutamide. Dosing will be the standard dosing, as described by the package insert.
  • 68Ga-PSMA-11 — DIAGNOSTIC_TEST
    \[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening and 12 weeks. Imaging agent for PSMA PET/CT.

Study Details

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.

Key Dates

Start date
Aug 12, 2021
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + 225Ac-J591 + ARI
    Patients will receive one dose of 225Ac-J591 (single dose, either 65 or 80 Kbq/kg) in combination with pembrolizumab (400mg every 6 weeks) and ARI (standard dose schedule, examples of ARI include enzalutamide, apalutamide, darolutamide).
  • Experimental: Pembrolizumab + ARI
    Patients will receive pembrolizumab (400mg every 6 weeks) and ARI (standard dose schedule) without 225Ac-J591.

Primary Outcome Measure

Proportion of patients with dose-limiting toxicity (DLT) following treatment with pembrolizumab and 225Ac-J591 [ Time Frame: From visit 1 through 12 weeks on study ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Himisha Beltran, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian/Brooklyn Methodist HospitalBrooklynNew York11215
Peter Gregos, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Cancer CenterNew YorkNew York10032
Cancer Clinical Trials Research Team
[email protected]
212-342-5162
Mark Stein, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian/Weill Cornell Medical CenterNew YorkNew York10021
GUOnc Research Team
[email protected]
Sarah Yuan
[email protected]
646-962-6040
Scott Tagawa, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Dana-Farber Cancer Institute· Boston, MANew York Presbyterian/Brooklyn Methodist Hospital· Brooklyn, NYColumbia University Irving Cancer Center· New York, NYNew York Presbyterian/Weill Cornell Medical Center· New York, NY

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