Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 11, 2020

Primary Completion Date

July 29, 2025

Study Completion Date

December 30, 2025

Conditions
Hormone Sensitive Prostate CancerProstate AdenocarcinomaMetastasis Prostate Adenocarcinoma
Interventions
DRUG

Androgen Deprivation Therapy

Given per standard care for duration of study. Regimens include Leuprolide (Lupron Depot) intramuscularly every 3 months, Goserelin acetate (Zoladex) subcutaneously every 4 weeks, or degarelix (Firmagon) subcutaneously every month per standard of care.

DRUG

Nivolumab

Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage; up to 28 cycles total.

DRUG

Docetaxel

Given once every 3 weeks intravenously at pre determined dosage for cycle 1-6.

Trial Locations (6)

21218

The Johns Hopkins University School of Medicine, Baltimore

33612

H. Lee Moffitt Cancer Center, Tampa

53706

University of Wisconsin, Madison

92093

University of California, San Diego, La Jolla

02115

Dana Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Xiao X. Wei, MD

OTHER