Clinical trial · Observational
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials
NCT03963518CI-TRIAL-00096336SURROGATE-ICIcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Time to next treatment or death (TNT-D) may be a patient-relevant endpoint in patients treated with immune checkpoint inhibitors. This study investigate
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Treated With Immune-checkpoint Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nivolumab monotherapy | Drug | — | UNRESOLVED |
| nivolumab plus ipilimumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control
- description
- nivolumab monotherapy
- interventionNames
- Drug: nivolumab monotherapy
- label
- Experimental
- description
- nivolumab plus ipilimumab
- interventionNames
- Drug: nivolumab plus ipilimumab
Primary outcomes (1)
- measure
- Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)
- timeFrame
- 4 years after the start of treatment
- description
- Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
previously untreated advanced melanoma patients.
References
Publications (2)
- BACKGROUNDBranchoux 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. PMID 31014514
- BACKGROUNDBranchoux 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. PMID 34929616