Cancer Treated With Immune-checkpoint Inhibitors
Conditions
Keywords
cancer, trial, immune-checkpoint inhibitors, meta-analysis
Brief summary
Time to next treatment or death (TNT-D) may be a patient-relevant endpoint in patients treated with immune checkpoint inhibitors. This study investigate
Interventions
nivolumab monotherapy
nivolumab plus ipilimumab
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Institut Bergonié
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
previously untreated advanced melanoma patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS) | 4 years after the start of treatment | Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control nivolumab monotherapy
nivolumab monotherapy: nivolumab monotherapy | 316 |
| Experimental nivolumab plus ipilimumab
nivolumab plus ipilimumab: nivolumab plus ipilimumab | 315 |
| Total | 631 |
Baseline characteristics
| Characteristic | Experimental | Total | Control |
|---|---|---|---|
| Age, Continuous | 59 years | 59 years | 59 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 315 participants | 631 participants | 316 participants |
| Sex: Female, Male Female | 113 Participants | 227 Participants | 114 Participants |
| Sex: Female, Male Male | 202 Participants | 404 Participants | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 175 / 316 | 151 / 315 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)
Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.
Time frame: 4 years after the start of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS) | 0.63 correlation coefficient |
| Experimental | Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS) | 0.66 correlation coefficient |