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NRG GI004

Trial Overview

Official Title

Testing Combination Chemotherapy with or without an Investigational Drug or the Investigational Drug Alone for Metastatic Colon or Rectal Cancer

Study Purpose

To learn if adding the experimental agent atezolizumab (MPDL3280A) to the usual treatment or giving the experimental agent alone is better than the usual treatment alone for metastatic colon or rectal cancer.

Diagnosis

Metastatic adenocarcinoma of colon or rectum

Eligibility

Prior Therapy: No previous chemotherapy or any other systemic therapy for metastatic colorectal cancer is allowed.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

Group 1 will get FOLFOX and bevacizumab (usual treatment)

Group 2 will get atezolizumab alone (investigational agent only)

Group 3 will receive FOLFOX and bevacizumab plus atezolizumab (usual treatment + investigational drug)

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Marker Status
Tumor determined to be mismatch-repair deficient (dMMR) with a panel of all four IHC markers, MLH1, MSH2, PMS2, and MSH6.
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
NRG-GI004
Related Specialties