At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 196 enrolled

Drug / intervention

Nivolumab +4 morebiological

Likely dose

Nivolumab at specified dose on specified days, combined with oxaliplatin, leucovorin, fluorouracil, and bevacizumabAI-extracted

Key inclusion· 4

✓Histologically confirmed metastatic colorectal cancer not amenable to curative resection
✓No prior chemotherapy for metastatic colorectal cancer
✓ECOG Performance Status 0-1
✓Ability to provide adequate tissue sample

Key exclusion· 3

✕Clinically relevant medical history including autoimmune disease, cardiovascular disease, hepatic disease, or bleeding disorders
✕Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody/drug targeting T-cell co-stimulation or checkpoint pathways
✕Positive test for hepatitis B virus or hepatitis C virus indicating presence of virus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03414983

NCT03414983Phase 3Completed

Compare CT.gov

An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer

Bristol-Myers Squibb·interventional·Posted Jan 30, 2018·Updated Nov 18, 2023

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Oxaliplatin, and 3 other interventions for Colorectal Cancer. Completed, enrolled 196 participants across 49 sites in 5 countries.

Detailed Summary

This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsColorectal Cancer

CountriesCanada, Japan, Puerto Rico, Spain, United States

CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished

201820192020202120222023202420252026

First PostedJan 2018

Enrollment StartFeb 2018

Primary CompletionFeb 2021

Study CompletionDec 2022

TodayJul 2026

First PostedJan 30, 2018

Enrollment StartFeb 20, 2018

Primary CompletionFeb 1, 2021

Study CompletionDec 28, 2022

TodayJul 2, 2026

Enrollment to primary: 2.9 yearsPosted 8.4 years ago