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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 (CheckMate 9X8)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414983
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE February 14, 2018
Estimated Primary Completion Date August 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
Progression Free Survival (PFS) [ Time Frame: Approximately 28 months ]
assessed by a Blinded Independent Central Review Committee (BICR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03414983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • Objective Response Rate (ORR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1
  • Disease Control Rate (DCR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1
  • Duration of Response (DoR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1
  • Time to Response (TTR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1
  • Overall Survival (OS) [ Time Frame: Approximately 28 months ]
  • Number of Adverse Events ( AEs) [ Time Frame: Approximately 28 months ]
  • Number of Serious Adverse Events ( SAEs) [ Time Frame: Approximately 28 months ]
  • Number of deaths [ Time Frame: Approximately 28 months ]
  • Number of clinical abnormalities [ Time Frame: Approximately 28 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • BMS-936558
    • Opdivo
  • Drug: Oxaliplatin
    Specified dose on specified day
  • Drug: Leucovorin
    Specified Dose on specified days
    Other Name: Calcium Folinate
  • Drug: Fluorouracil
    Specified dose on specified days
  • Drug: Bevacizumab
    Specified dose on specified days
    Other Name: Avastin
Study Arms  ICMJE
  • Experimental: Arm A
    Nivo + SOC
    Interventions:
    • Biological: Nivolumab
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: Fluorouracil
    • Drug: Bevacizumab
  • Active Comparator: Arm B
    SOC
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: Fluorouracil
    • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 18, 2022
Estimated Primary Completion Date August 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States,   Canada,   Japan,   Puerto Rico,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03414983
Other Study ID Numbers  ICMJE CA209-9X8
2017-003662-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Suibb
PRS Account Bristol-Myers Squibb
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP