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

Part of paid clinical trials in La Jolla, California.

Sponsor
Xiao X. Wei, MD
Study ID
NCT04126070
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Hormone Sensitive Prostate Cancer
  • Metastasis Prostate Adenocarcinoma
  • Prostate Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Androgen Deprivation Therapy — DRUG
    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.
  • Nivolumab — DRUG
    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.
  • Docetaxel — DRUG
    Given once every 3 weeks intravenously at pre determined dosage for cycle 1-6.

Study Details

This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are: * Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon). * Docetaxel * Nivolumab

Key Dates

Start date
May 11, 2020
Status verified
Jan 2026
Primary completion
Jul 29, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed Tumor
    After the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial. * Androgen Deprivation Therapy: Given per standard care for duration of study * Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage * Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6.
  • Experimental: COHORT 2: Inflamed Tumor without DNA repair defects (DDRD)
    After the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial. * Androgen Deprivation Therapy: Given per standard care for duration of study * Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage * Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6.
  • Experimental: COHORT 3: Biomarker Negative
    After the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial. * Androgen Deprivation Therapy: Given per standard care for duration of study * Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage * Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6

Primary Outcome Measure

Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy [ Time Frame: 7 months from the start of chemoimmunotherapy ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
The Johns Hopkins University School of MedicineBaltimoreMaryland21218-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of WisconsinMadisonWisconsin53706-

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University of California, San Diego· La Jolla, CAH. Lee Moffitt Cancer Center· Tampa, FLThe Johns Hopkins University School of Medicine· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAUniversity of Wisconsin· Madison, WI

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