CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 milligramsfrom 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/NCT03332498
NCT03332498Phase 2Completed
CompareCT.gov

A Phase I/II Study of Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal Cancers

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Nov 6, 2017·Updated Jun 3, 2022

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Ibrutinib for Colon Cancer and 3 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) (or the highest protocol-defined dose level in the absence of establishing an MTD) of ibrutinib in combination with pembrolizumab in participants with advanced, refractory colorectal cancers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer, Colorectal Cancer, Colorectal Carcinoma, Colon Disease
CountriesUnited States
CollaboratorsJanssen Scientific Affairs, LLC, Merck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 6, 2017
Enrollment StartJan 24, 2018
Primary CompletionDec 5, 2019
Study CompletionSep 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.7 years ago

Interventions

Pembrolizumabdrug

200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.

Ibrutinibdrug

Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.