CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Durvalumab +3 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/NCT02754856
NCT02754856Phase 1Completed
CompareCT.gov

Pilot Study Assessing the Safety and Tolerability of the Neoadjuvant Use of Tremelimumab (Anti-CTLA-4) Plus Durvalumab (MEDI4736) (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases

M.D. Anderson Cancer Center·interventional·Posted Apr 28, 2016·Updated Oct 9, 2024

In Brief

A Phase 1 clinical trial evaluating Durvalumab, Laboratory Biomarker Analysis, and 2 other interventions for Metastatic Carcinoma in the Liver and 4 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, 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--
ConditionsMetastatic Carcinoma in the Liver, Resectable Mass, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartAug 29, 2016
Primary CompletionJan 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 10.2 years ago

Interventions

Durvalumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Therapeutic Conventional Surgeryprocedure

Undergo liver surgery

Tremelimumabbiological

Given IV