CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Durvalumab +1 morebiological
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/NCT03204812
NCT03204812Phase 2Completed
CompareCT.gov

A Pilot Trial to Explore the Link Between Immunological Changes, Efficacy, Safety, and Tolerability of Durvalumab (MEDI4736) Plus Tremelimumab in Chemotherapy-Naïve Men With Metastatic Castration-Resistant Prostate Cancer (CRPC)

M.D. Anderson Cancer Center·interventional·Posted Jul 2, 2017·Updated Oct 15, 2024

In Brief

A Phase 2 clinical trial evaluating Durvalumab and Tremelimumab for Castration-Resistant Prostate Carcinoma and 5 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed Summary

This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCastration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartJul 14, 2017
Primary CompletionApr 13, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9 years ago

Interventions

Durvalumabbiological

Given IV

Tremelimumabbiological

Given IV