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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

NCT03143153

Description:

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

Related Conditions:
  • Esophageal Adenosquamous Carcinoma
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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: 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-648
  • SECONDARY ID: 2016-001514-20
  • NCT ID: NCT03143153

Conditions

  • Various Advanced Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558 (Nivolumab), Opdivo (Nivolumab)Nivolumab + Ipilimumab
IpilimumabBMS-734016 (Ipilimumab), Yervoy (Ipilimumab)Nivolumab + Ipilimumab
CisplatinNivolumab + Cisplatin + Fluorouacil
FluorouracilNivolumab + Cisplatin + Fluorouacil

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + IpilimumabExperimental
  • Nivolumab
  • Ipilimumab
Nivolumab + Cisplatin + FluorouacilExperimental
  • Nivolumab
  • Cisplatin
  • Fluorouracil
Cisplatin + FluorouracilActive Comparator
  • Cisplatin
  • Fluorouracil

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Approximately 49 months from time first pstient is randomized
Safety Issue:
Description:In subjects with PD-L1 expressing tumors

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Approximately 49 months from time first patient is randomized
Safety Issue:
Description:In All Randomized subjects
Measure:Progression-free Survival (PFS)
Time Frame:Approximately 33 months from time first patient is randomized
Safety Issue:
Description:As assessed by BICR in All Randomized subjects
Measure:Objective Response Rate (ORR)
Time Frame:Approximately 33 months from time first patient is randomized
Safety Issue:
Description:As assessed by BICR in subjects with PD-L1 expressing tumors and All Randomized subjects

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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