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An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread

NCT03414983 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2023-11-18

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

Nivolumab

Specified dose on specified days

DRUG

Oxaliplatin

Specified dose on specified days

DRUG

Leucovorin

Specified dose on specified days

DRUG

Fluorouracil

Specified dose on specified days

DRUG

Bevacizumab

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Suibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2021-02-01
Completion
2022-12-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03414983 on ClinicalTrials.gov