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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

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date August 28, 2020
Actual Study Start Date  ICMJE June 19, 2017
Estimated Primary Completion Date August 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Overall survival (OS) [ Time Frame: Approximately 49 months from time first pstient is randomized ]
    In subjects with PD-L1 expressing tumors
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Overall survival (OS) [ Time Frame: Approximately 49 months from time first patient is randomized ]
    In All Randomized subjects
  • Progression-free Survival (PFS) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by BICR in All Randomized subjects
  • 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
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 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Various Advanced Cancer
Intervention  ICMJE
  • 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)
  • Drug: Cisplatin
    Specified dose on specified days
  • Drug: Fluorouracil
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Nivolumab + Ipilimumab
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Nivolumab + Cisplatin + Fluorouacil
    Interventions:
    • Biological: Nivolumab
    • Drug: Cisplatin
    • Drug: Fluorouracil
  • Active Comparator: Cisplatin + Fluorouracil
    Interventions:
    • Drug: Cisplatin
    • Drug: Fluorouracil
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: May 4, 2017)
939
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 16, 2024
Estimated Primary Completion Date August 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   France,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Mexico,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03143153
Other Study ID Numbers  ICMJE CA209-648
2016-001514-20 ( 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 Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

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