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Active Clinical Trials

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 (CheckMate 9X8)

Active NCT:
03414983
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Bristol-Myers Squibb
Contact: 

For more information, please contact Luann Healy by telephone at 412-359-8420 or email at Luann.Healy@ahn.org or Julie Russo by telephone at 412-359-6851 or email Julie.Russo@ahn.org.

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 (CheckMate 9X8: CHECKpoint pathway and nivoluMab clinical Trial Evaluation 9X8)

Purpose: 

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).

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Histologically confirmed metastatic colorectal cancer, not amenable to curative resection

No prior chemotherapy for metastatic colorectal cancer

ECOG Performance Status of 0-1

Ability to provide adequate tissue sample

Exclusion Criteria:

Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus