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A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin (CheckMate 648)

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: NCT03143153
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : August 28, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Condition or disease Intervention/treatment Phase
Various Advanced Cancer Biological: Nivolumab Biological: Ipilimumab Drug: Cisplatin Drug: Fluorouracil Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 939 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : August 16, 2021
Estimated Study Completion Date : August 16, 2024

Resource links provided by the National Library of Medicine


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

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016 (Ipilimumab)
  • Yervoy (Ipilimumab)
Experimental: Nivolumab + Cisplatin + Fluorouacil Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)

Drug: Cisplatin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days
Active Comparator: Cisplatin + Fluorouracil Drug: Cisplatin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 49 months from time first pstient is randomized ]
    In subjects with PD-L1 expressing tumors

  2. Progression-free Survival (PFS) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by blinded independent central review committee (BICR) in subjects with PD-L1 expressing tumors


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 49 months from time first patient is randomized ]
    In All Randomized subjects

  2. Progression-free Survival (PFS) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by BICR in All Randomized subjects

  3. Objective Response Rate (ORR) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by BICR in subjects with PD-L1 expressing tumors and All Randomized subjects


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 Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
  • Male or Female at least 18 years of age
  • Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria

  • Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable 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): NCT03143153


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 Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03143153    
Other Study ID Numbers: CA209-648
2016-001514-20 ( EudraCT Number )
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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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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Fluorouracil
Nivolumab
Ipilimumab
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological