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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Time to next treatment or death (TNT-D) may be a patient-relevant endpoint in patients treated with immune checkpoint inhibitors. This study investigate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | nivolumab monotherapy |
| |
| Experimental | nivolumab plus ipilimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab monotherapy | Drug | nivolumab monotherapy |
| |
| nivolumab plus ipilimumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years after the start of treatment |
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previously untreated advanced melanoma patients.
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previously untreated advanced melanoma patients included in a recently published clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Carine A Bellera, PhD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié, Comprehensive Cancer Center | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31014514 | Background | 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. | |
| 34929616 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | nivolumab monotherapy nivolumab monotherapy: nivolumab monotherapy |
| FG001 | Experimental | nivolumab plus ipilimumab nivolumab plus ipilimumab: nivolumab plus ipilimumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | nivolumab monotherapy nivolumab monotherapy: nivolumab monotherapy |
| BG001 | Experimental | nivolumab plus ipilimumab nivolumab plus ipilimumab: nivolumab plus ipilimumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | correlation coefficient | 4 years after the start of treatment |
|
up to 4 years after the start of treatment Only all-cause mortality was collected for the purpose of this study. Adverse events (serious and non-serious) were not collected for the purpose of this study.
Adverse events (serious and non-serious) were not collected for the purpose of this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | nivolumab monotherapy nivolumab monotherapy: nivolumab monotherapy | 175 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carine Bellera | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33556333333 | c.bellera@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2017 | Aug 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
nivolumab plus ipilimumab |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 316 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Experimental | nivolumab plus ipilimumab nivolumab plus ipilimumab: nivolumab plus ipilimumab | 151 | 315 | 0 | 0 | 0 | 0 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |