CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Ipilimumab +2 morebiological
Likely dose
Ipilimumab 1 mg/kgfrom 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/NCT02601014
NCT02601014Phase 2Completed
CompareCT.gov

Biomarker-Driven Phase-2 Study of Combined Immune Checkpoint Blockade for AR-V7-Expressing Metastatic Castration-Resistant Prostate Cancer (STARVE-PC)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Nov 10, 2015·Updated Feb 3, 2022

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, Nivolumab, and 1 other intervention for Prostate Cancer and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy and some chemotherapy in patients with prostate cancer. Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key biomarkers or proteins that help tumor cells to escape the immune system surveillance and this may help the immune system to kill tumor cells that express AR-V7.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Recurrent Prostate Carcinoma, Stage IV Prostate Adenocarcinoma
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 10, 2015
Enrollment StartMar 15, 2016
Primary CompletionDec 3, 2020
Study CompletionOct 6, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.6 years ago

Interventions

Ipilimumabbiological

Given 1 mg/kg IV

Nivolumabbiological

Given 3 mg/kg IV

Enzalutamidedrug

given orally per standard of care