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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 May 2017 |
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Main ID: |
NCT03138486 |
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Date of registration:
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01/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of the Effectiveness in Patients With Gastric or Gastroesophageal Junction Cancer With Nivolumab by Itself or in Combination With Ipilimumab and in Patients With Esophageal Cancer With Combination of Nivolumab and Ipilimumab.
CheckMate 648 |
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Scientific title:
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A Two-Cohort, Open-label, Randomized Phase 2 Study of Nivolumab Monotherapy and in Combination With Ipilimumab in Subjects With Advanced or Metastatic, Previously Treated Gastric Gastroesophageal Junction, or Previously Untreated Esophageal Cancer |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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939 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03138486 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Chile
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Colombia
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Czechia
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Italy
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Japan
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Peru
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Poland
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Romania
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Russian Federation
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United Kingdom
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Contacts
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Name:
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Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
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Address:
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Telephone:
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please email: |
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Email:
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Clinical.Trials@bms.com |
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Affiliation:
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Must have gastric, esophageal or gastroesophageal junction cancer that cannot be
operated on, that is advanced or has spread out
Exclusion Criteria
- Presence of tumor cells in the brain or spinal cord that have not been treated
- Active known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Various Advanced Cancer
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Intervention(s)
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Drug: Nivolumab + Ipilimumab
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Drug: Nivolumab + Ipilimumab followed by Nivolumab monotherapy
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Drug: Nivolumab monotherapy
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Primary Outcome(s)
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Investigator Assessed Objective Response Rate (ORR) of GC (Gastric Cancer) Cohort
[Time Frame: Up to 22 months]
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Investigator Assessed ORR of EC (Esophageal Cancer) Cohort
[Time Frame: Up to 22 months]
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Secondary Outcome(s)
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BIRC assessed ORR of Cohort EC
[Time Frame: Up to 22 months]
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Progression Free Survival (PFS) of Cohort GC
[Time Frame: Up to 22 months]
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Blinded Independent Radiology Review Committee (BIRC) assessed ORR of Cohort GC
[Time Frame: Up to 22 months]
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OS of Cohort EC
[Time Frame: Up to 22 months]
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Overall Survival (OS) of Cohort GC
[Time Frame: Up to 22 months]
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PFS of Cohort EC
[Time Frame: Up to 22 months]
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Secondary ID(s)
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CA209-648
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2016-001514-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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