Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 17, 2017

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Prostatic Neoplasms
Interventions
DRUG

Pembrolizumab

200 mg IV every 21 days for up to 13 doses (Arms 1 and 2)

DRUG

SD-101

5 mg will be delivered to the dominant prostatic tumor lesion at time of fiducial marker placement (1-5 weeks prior to Cycle 1, Day 1) and and 1-3 weeks after Cycle 1 Day 1

DRUG

Leuprolide acetate

22.5 mg will be given intramuscularly (IM). First injection 3 months prior to Cycle 1 Day 1. Intermittent androgen deprivation therapy will be given every 3 months starting Cycle 1, Day 1 for 3 additional doses.

DRUG

Abiraterone Acetate

1000 mg oral dosage will be given daily for 3 months prior to Cycle 1, Day 1 and daily for 9 months starting Cycle 1, Day 1.

DRUG

Prednisone

5 mg oral dosage will be given daily for 3 months prior to Cycle 1 Day 1 and daily for 9 months starting Cycle 1, Day 1.

RADIATION

Stereotactic Body Radiation Therapy

7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.

Trial Locations (1)

94115

University of California San Francisco, San Francisco

All Listed Sponsors
collaborator

Prostate Cancer Foundation

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

TriSalus Life Sciences, Inc.

INDUSTRY

lead

David Oh

OTHER

NCT03007732 - Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT | Biotech Hunter | Biotech Hunter