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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
Results First Posted : February 25, 2022
Last Update Posted : March 14, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: Nivolumab Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil Drug: Bevacizumab Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : February 1, 2021
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
Nivo + SOC
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Oxaliplatin
Specified dose on specified days

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
Active Comparator: Arm B
SOC
 Drug: Oxaliplatin
Specified dose on specified days

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


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) [ Time Frame: From randomization to up to the date of the first documented progression (up to 16 months) ]
    PFS is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) [ Time Frame: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to 36 months) ]
    ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.

  2. Objective Response Rate (ORR) Per Investigator Assessment [ Time Frame: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to 36 months) ]
    ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.

  3. Progression Free Survival (PFS) Per Investigator Assessment [ Time Frame: From randomization up to the date of the first documented progression (up to 16 months) ]
    PFS is defined as the time from randomization to the date of the first documented progression, as determined by tumor assessments by the Investigator, or death due to any cause, whichever occurs first.

  4. Time to Objective Response Per Blinded Independent Central Review (BICR) [ Time Frame: From the randomization date up to the date of the first confirmed CR or PR (up to 36 months) ]
    Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed CR or PR (as assessed by BICR and as assessed by investigator). TTR is derived for responders only.

  5. Time to Objective Response Per Investigator Assessment [ Time Frame: From the randomization date up to the date of the first confirmed CR or PR (up to 36 months) ]
    TTR is defined as the time from the randomization date to the date of the first confirmed CR or PR (as assessed by BICR and as assessed by investigator). TTR is derived for responders only.

  6. Duration of Response (DoR) Per Blinded Independent Central Review (BICR) [ Time Frame: From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 14 months) ]
    Duration of objective response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first.

  7. Duration of Response (DoR) Per Investigator Assessment [ Time Frame: From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 15 months) ]
    Duration of objective response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first.

  8. Overall Survival (OS) Summary [ Time Frame: From the date of randomization up to the date of death (up to 36 months) ]
    OS is defined as the time from the date of randomization to the date of death. A participant who has not died will be censored at last known date alive.

  9. Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to 30 days post last dose (up to 35 months) ]
    Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability

  10. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From first dose to 30 days post last dose (up to 35 months) ]
    Number of participants with any grade of serious adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability

  11. Deaths [ Time Frame: From first dose up to 6 weeks post last dose (up to 36 months) ]
    The number of participants who died during the treatment period

  12. Abnormalities in Specific Liver Tests [ Time Frame: From first dose up to 30 days post last dose (up to 35 months) ]
    Laboratory test results of laboratory abnormalities in hepatic parameters during the treatment period per CTCAE (Version 4) in SI units.

  13. Abnormalities in Specific Thyroid Tests [ Time Frame: From first dose up to 30 days post last dose (up to 35 months) ]
    Laboratory test results of laboratory abnormalities in specific thyroid tests during the treatment period per CTCAE (Version 4) in SI units.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414983


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Suibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] November 13, 2020
Statistical Analysis Plan  [PDF] March 18, 2021

More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03414983    
Other Study ID Numbers: CA209-9X8
2017-003662-27 ( EudraCT Number )
First Posted: January 30, 2018    Key Record Dates
Results First Posted: February 25, 2022
Last Update Posted: March 14, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Nivolumab
Fluorouracil
 Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Immune Checkpoint Inhibitors
Antidotes