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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Leucovorin; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Fluorouracil; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03414983

CA209-9X8

2017-003662-27 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

196 participants in 2 patient groups

Arm A

Experimental group

Description:

Nivo + SOC

Treatment:

Biological: Nivolumab

Drug: Bevacizumab

Drug: Fluorouracil

Drug: Leucovorin

Drug: Oxaliplatin

Arm B

Active Comparator group

Description:

SOC

Treatment:

Drug: Bevacizumab

Drug: Fluorouracil

Drug: Leucovorin

Drug: Oxaliplatin