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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 12, 2021

Primary Completion Date

October 31, 2027

Study Completion Date

December 31, 2029

Conditions
Prostate Cancer
Interventions
DRUG

225Ac-J591

Alpha-emitter Actinium-225 conjugated to the anti-PSMA antibody J591.

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously, 400mg every 6 weeks. Patients may receive maximum 18 cycles of therapy, approximately 2 years.

DRUG

Androgen receptor inhibitor

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.

DIAGNOSTIC_TEST

68Ga-PSMA-11

\[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening and 12 weeks. Imaging agent for PSMA PET/CT.

Trial Locations (4)

10021

RECRUITING

New York Presbyterian/Weill Cornell Medical Center, New York

10032

RECRUITING

Columbia University Irving Cancer Center, New York

11215

RECRUITING

New York Presbyterian/Brooklyn Methodist Hospital, Brooklyn

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER