CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Cetuximab +2 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/NCT02713373
NCT02713373Phase 2Completed
CompareCT.gov

A Phase Ib/II Study of Cetuximab and Pembrolizumab in Metastatic Colorectal Cancer

Roswell Park Cancer Institute·interventional·Posted Mar 18, 2016·Updated Oct 6, 2022

In Brief

A Phase 2 clinical trial evaluating Cetuximab, Laboratory Biomarker Analysis, and 1 other intervention for Recurrent Colorectal Carcinoma and 2 related conditions. Completed, enrolled 45 participants across 2 sites.

Detailed Summary

This phase I/II trial studies the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) or that cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Colorectal Carcinoma, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Merck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 18, 2016
Enrollment StartAug 5, 2016
Primary CompletionJul 28, 2020
Study CompletionJul 20, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.3 years ago

Interventions

Cetuximabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV