Trial · NCT03068455
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free Survival (RFS) - All Randomized Participants | From randomization to Primary Completion Date (up to approximately 3 years) | RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median values based on Kaplan-Meier Estimates. |
| Primary | Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1% | From randomization to Primary Completion Date (up to approximately 3 years) | RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates. |
| Secondary | Overall Survival (OS) - All Randomized Participants | From randomization to date of death (up to approximately 45 months) | OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates. |
| Secondary | Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1% | From randomization to date of death (up to approximately 45 months) | OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates. |
| Secondary | Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression | From randomization to Study Completion Date (up to approximately 45 months) | RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates. |
| Secondary | Time to Next-Line Therapies - All Randomized Participants | From randomization to start of next therapy or second next therapy (up to approximately 45 months) | Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date. Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date. |
| Secondary | Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1% | From randomization to start of next therapy or second next therapy (up to approximately 45 months) | Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date. Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date |
| Secondary | Time From Next Therapy to Second Next Therapy - All Randomized Participants | From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months) | Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment. |
| Secondary | Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1% | From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months) | Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment. |
| Secondary | Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants | From randomization to progression event (up to approximately 45 months) | PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death. |
| Secondary | Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1% | From randomization to progression event (up to approximately 45 months) | PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03068455/registered