Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
NCT ID: NCT03963518
Last Updated: 2025-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
631 participants
OBSERVATIONAL
2017-01-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Control
nivolumab monotherapy
nivolumab monotherapy
nivolumab monotherapy
Experimental
nivolumab plus ipilimumab
nivolumab plus ipilimumab
nivolumab plus ipilimumab
Interventions
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nivolumab monotherapy
nivolumab monotherapy
nivolumab plus ipilimumab
nivolumab plus ipilimumab
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Institut Bergonié
OTHER
Responsible Party
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Principal Investigators
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Carine A Bellera, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonié
Locations
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Institut Bergonié, Comprehensive Cancer Center
Bordeaux, , France
Countries
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References
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Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V. Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review. Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.
Branchoux S, Sofeu CL, Gaudin AF, Kurt M, Moshyk A, Italiano A, Bellera C, Rondeau V. Time to next treatment or death as a candidate surrogate endpoint for overall survival in advanced melanoma patients treated with immune checkpoint inhibitors: an insight from the phase III CheckMate 067 trial. ESMO Open. 2022 Feb;7(1):100340. doi: 10.1016/j.esmoop.2021.100340. Epub 2021 Dec 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IB2017-SURROGATE-ICI
Identifier Type: -
Identifier Source: org_study_id
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