CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 47 enrolled
Drug / intervention
Androgen Deprivation Therapy +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04126070
NCT04126070Phase 2Active

A Phase 2 Multicohort Study of Nivolumab in Combination With Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients With DNA Damage Repair Defects or Inflamed Tumors

Xiao X. Wei, MD·interventional·Posted Oct 14, 2019·Updated May 27, 2026

In Brief

A Phase 2 clinical trial evaluating Androgen Deprivation Therapy, Nivolumab, and 1 other intervention for Hormone Sensitive Prostate Cancer and 2 related conditions. Active but no longer recruiting, targeting 47 participants across 6 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2ActiveOverdue
2020202120222023202420252026
First PostedOct 14, 2019
Enrollment StartMay 11, 2020
Primary CompletionJul 29, 2025
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 6.7 years ago

Interventions

Androgen Deprivation Therapydrug

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.

Nivolumabdrug

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.

Docetaxeldrug

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