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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

Description:

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).

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-9X8
  • SECONDARY ID: 2017-003662-27
  • NCT ID: NCT03414983

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoArm A
OxaliplatinArm A
LeucovorinCalcium FolinateArm A
FluorouracilArm A
BevacizumabAvastinArm A

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).

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalNivo + SOC
  • Nivolumab
  • Oxaliplatin
  • Leucovorin
  • Fluorouracil
  • Bevacizumab
Arm BActive ComparatorSOC
  • Oxaliplatin
  • Leucovorin
  • Fluorouracil
  • Bevacizumab

Eligibility Criteria

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        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 could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Approximately 28 months
Safety Issue:
Description:assessed by a Blinded Independent Central Review Committee (BICR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Approximately 28 months
Safety Issue:
Description:assessed by a BICR per RECIST v1.1
Measure:Disease Control Rate (DCR)
Time Frame:Approximately 28 months
Safety Issue:
Description:assessed by a BICR per RECIST v1.1
Measure:Duration of Response (DoR)
Time Frame:Approximately 28 months
Safety Issue:
Description:assessed by a BICR per RECIST v1.1
Measure:Time to Response (TTR)
Time Frame:Approximately 28 months
Safety Issue:
Description:assessed by a BICR per RECIST v1.1
Measure:Overall Survival (OS)
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Number of Adverse Events ( AEs)
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Number of Serious Adverse Events ( SAEs)
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Number of deaths
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Number of clinical abnormalities
Time Frame:Approximately 28 months
Safety Issue:
Description:

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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