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Protocol No. UW18004

Principal Investigator Deming, Dustin

Phase II/III

Age Group Adult

Scope National

Sponsor Type Industry

Title 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

Objective The purpose of this study is to characterize the effectiveness (how well the drug works) of nivolumab in combination with standard of care (bevacizumab plus a standard chemotherapy regimen consisting of Oxaliplatin, Leucovorin and fluorouracil also known as mFOLFOX6) when diagnosed with metastatic colorectal cancer by comparing it to the effectiveness seen in participants treated with the standard of care alone (bevacizumab plus mFOLFOX6).
In this study effectiveness will be measured by looking at how long participants live until their disease gets worse (progression-free survival). The percentage of participants whose cancer shrinks and/or disappears after treatment (objective response rate) as well as the safety and tolerability observed in both study groups (nivolumab + standard of care and standard of care alone) will also be looked at.
This study will also explore if certain genetics factors (biomarkers) may influence positively or negatively the response to treatment.

Treatment Arm A: nivolumab plus bevacizumab (also known as Avastin) and a chemotherapy regimen consisting of oxaliplatin, leucovorin (or equivalent) and fluorouracil, this chemotherapy regimen is also known as mFOLFOX6. This arm is also referred to as nivolumab plus standard of care (SOC). OR
Arm B: bevacizumab plus mFOLFOX6 alone. This arm is also referred to as the standard of care arm.

Description An open-label, Phase 2/3 study of Nivolumab with Standard of care vs Standard of care for First-Line Treatment of Metastatic Colorectal Cancer

Key Eligibility
  • Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
  • Available local test results for tumor BRAF, KRAS and NRAS (extended RAS) mutation status and Microsatellite/MMR testing in addition to available tumor sample as required per protocol
  • No prior chemotherapy for metastatic colorectal cancer
  • Presence of measurable disease by RECIST 1.1 criteria
  • ECOG Performance Status of 0-1
  • Males and Females, ages greater than or equal to 18 years of age
  • Women must not be pregnant or breastfeeding, and must agree to adequate birth control
  • No active brain metastases or leptomeningeal metastases
  • No ascites that cannot be controlled with medical therapy alone
  • No active, known or suspected autoimmune disease
  • No conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications
  • No history of interstitial lung disease or pneumonitis
  • No prior malignancy active within the previous 3 years
  • No clinically significant cardiovascular disease
  • Pre-existing hypertension should be adequately controlled to < 140/90 mmHg
  • No clinically significant bleeding diathesis or coagulopathy
  • Participants can not have > Grade 1 peripheral neuropathy
  • Adequate hematologic, renal and liver function
  • No known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • No hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative)

  • Applicable Disease Sites Colon and Rectum

    Status Open

    Participating Institutions UW Hospital and Clinics