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Trial · NCT03963518

Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)

NCT03963518, Completed, Institut Bergonié; results first posted 2025-09-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI). Trials, record NCT03963518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03963518

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
NCT number
NCT03963518
Status
Completed
Enrollment
631 participants, actual
Lead sponsor
Institut Bergonié
Conditions
Cancer Treated With Immune-checkpoint Inhibitors
Interventions
nivolumab monotherapy, nivolumab plus ipilimumab
First posted
2019-05-24
Last updated
2025-10-06
Results first posted
2025-09-15

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCorrelation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)4 years after the start of treatmentCorrelation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCorrelation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)4 years after the start of treatmentcorrelation coefficientNUMBER

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)Control0.6395% Confidence Interval 0.59 to 0.67correlation coefficient
Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)Experimental0.6695% Confidence Interval 0.62 to 0.70correlation coefficient

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDControl316
Overall StudySTARTEDExperimental315
Overall StudyCOMPLETEDControl316
Overall StudyCOMPLETEDExperimental315
Overall StudyNOT COMPLETEDControl0
Overall StudyNOT COMPLETEDExperimental0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityControl175316
Total, all-cause mortalityExperimental151315
Total, other adverse eventsControl00
Total, other adverse eventsExperimental00
Total, serious adverse eventsControl00
Total, serious adverse eventsExperimental00

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
31014514BACKGROUNDPubMed
34929616BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Experimental vs Control: deaths from any cause

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03963518

GET https://conductscience.org/api/trials/v1/NCT03963518/registered