Trial Outcomes & Findings for Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI) (NCT NCT03963518)
NCT ID: NCT03963518
Last Updated: 2025-10-06
Results Overview
Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.
Recruitment status
COMPLETED
Target enrollment
631 participants
Primary outcome timeframe
4 years after the start of treatment
Results posted on
2025-10-06
Participant Flow
Participant milestones
| Measure |
Control
nivolumab monotherapy
nivolumab monotherapy: nivolumab monotherapy
|
Experimental
nivolumab plus ipilimumab
nivolumab plus ipilimumab: nivolumab plus ipilimumab
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
315
|
|
Overall Study
COMPLETED
|
316
|
315
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=316 Participants
nivolumab monotherapy
nivolumab monotherapy: nivolumab monotherapy
|
Experimental
n=315 Participants
nivolumab plus ipilimumab
nivolumab plus ipilimumab: nivolumab plus ipilimumab
|
Total
n=631 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=316 Participants
|
59 years
n=315 Participants
|
59 years
n=631 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=316 Participants
|
113 Participants
n=315 Participants
|
227 Participants
n=631 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=316 Participants
|
202 Participants
n=315 Participants
|
404 Participants
n=631 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
316 participants
n=316 Participants
|
315 participants
n=315 Participants
|
631 participants
n=631 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=316 Participants
nivolumab monotherapy
nivolumab monotherapy: nivolumab monotherapy
|
Experimental
n=315 Participants
nivolumab plus ipilimumab
nivolumab plus ipilimumab: nivolumab plus ipilimumab
|
|---|---|---|
|
Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)
|
0.63 correlation coefficient
Interval 0.59 to 0.67
|
0.66 correlation coefficient
Interval 0.62 to 0.7
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 175 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 151 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carine Bellera
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR
Phone: +33556333333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place