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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

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)
Estimated Enrollment : 180 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 14, 2018
Estimated Primary Completion Date : August 16, 2021
Estimated Study Completion Date : August 18, 2022

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 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
Active Comparator: Arm B
SOC
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1

  2. Disease Control Rate (DCR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1

  3. Duration of Response (DoR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1

  4. Time to Response (TTR) [ Time Frame: Approximately 28 months ]
    assessed by a BICR per RECIST v1.1

  5. Overall Survival (OS) [ Time Frame: Approximately 28 months ]
  6. Number of Adverse Events ( AEs) [ Time Frame: Approximately 28 months ]
  7. Number of Serious Adverse Events ( SAEs) [ Time Frame: Approximately 28 months ]
  8. Number of deaths [ Time Frame: Approximately 28 months ]
  9. Number of clinical abnormalities [ Time Frame: Approximately 28 months ]

Eligibility Criteria
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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

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

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


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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
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03414983     History of Changes
Other Study ID Numbers: CA209-9X8
2017-003662-27 ( EudraCT Number )
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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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
Bevacizumab
Nivolumab
Oxaliplatin
 Fluorouracil
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