Trial · NCT03068455
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
NCT03068455, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2021-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma. Trials, record NCT03068455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03068455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
- NCT number
- NCT03068455
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,844 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Melanoma
- Interventions
- nivolumab, ipilimumab
- First posted
- 2017-03-01
- Last updated
- 2021-09-20
- Other registries' IDs
- eudract:2016-003729-41
- Results first posted
- 2021-07-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival (RFS) - All Randomized Participants | From randomization to Primary Completion Date (up to approximately 3 years) | All randomized participants with completely resected stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma | Months | MEDIAN |
| 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) | All randomized participants with PD-L1 expression level \< 1% and with completely resected stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma. PD-L1 expression levels based on Interactive Response Technology (IRT) | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) - All Randomized Participants | From randomization to date of death (up to approximately 45 months) | All randomized participants with completely resected stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1% | From randomization to date of death (up to approximately 45 months) | All randomized participants with PD-L1 expression level \< 1% and with completely resected stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma | Months | MEDIAN |
| SECONDARY | Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression | From randomization to Study Completion Date (up to approximately 45 months) | All randomized participants with variable PD-L1 expression levels (see data table for details). PD-L1 expression levels based on clinical database. | Months | MEDIAN |
| 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) | All randomized participants | Months | MEDIAN |
| 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) | All randomized participants with PD-L1 expression level \< 1% | Months | MEDIAN |
| 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) | All randomized participants who received first and second next systemic therapy | Months | MEDIAN |
| 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) | All randomized participants with PD-L1 expression level \< 1% who received first and second next therapy | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants | From randomization to progression event (up to approximately 45 months) | All randomized participants | Months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrence-free Survival (RFS) - All Randomized Participants | Arm A: Nivo + Ipi | NA | 95% Confidence Interval NA to NA | Months | |
| Recurrence-free Survival (RFS) - All Randomized Participants | Arm B: Nivo | NA | 95% Confidence Interval NA to NA | Months | |
| Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1% | Arm A: Nivo + Ipi | 33.15 | 95% Confidence Interval 22.21 to NA | Months | |
| Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1% | Arm B: Nivo | 27.63 | 95% Confidence Interval 19.81 to NA | Months | |
| Overall Survival (OS) - All Randomized Participants | Arm A: Nivo + Ipi | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) - All Randomized Participants | Arm B: Nivo | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1% | Arm A: Nivo + Ipi | NA | 95% Confidence Interval 41.72 to NA | Months | |
| Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1% | Arm B: Nivo | NA | 95% Confidence Interval NA to NA | Months | |
| Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression | Arm A: Nivo + Ipi | < 1% Tumor PD-L1 Expression | 33.18 | 95% Confidence Interval 22.21 to NA | Months |
| Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression | Arm B: Nivo | < 1% Tumor PD-L1 Expression | 25.33 | 95% Confidence Interval 19.81 to NA | Months |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-treatment Period | STARTED | Arm A: Nivo + Ipi | 920 | |
| Pre-treatment Period | STARTED | Arm B: Nivo | 924 | |
| Pre-treatment Period | COMPLETED | Arm A: Nivo + Ipi | 916 | |
| Pre-treatment Period | COMPLETED | Arm B: Nivo | 917 | |
| Pre-treatment Period | NOT COMPLETED | Arm A: Nivo + Ipi | 4 | |
| Pre-treatment Period | NOT COMPLETED | Arm B: Nivo | 7 | |
| Treatment Period | STARTED | Arm A: Nivo + Ipi | 916 | |
| Treatment Period | STARTED | Arm B: Nivo | 917 | |
| Treatment Period | COMPLETED | Arm A: Nivo + Ipi | 364 | |
| Treatment Period | COMPLETED | Arm B: Nivo | 561 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events758
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Adrenal insufficiency | Endocrine disorders | Arm A: Nivo + Ipi | 56 | 916 | |
| other | Adrenal insufficiency | Endocrine disorders | Arm B: Nivo | 7 | 917 | |
| other | Hyperthyroidism | Endocrine disorders | Arm A: Nivo + Ipi | 180 | 916 | |
| other | Hyperthyroidism | Endocrine disorders | Arm B: Nivo | 98 | 917 | |
| other | Hypophysitis | Endocrine disorders | Arm A: Nivo + Ipi | 92 | 916 | |
| other | Hypophysitis | Endocrine disorders | Arm B: Nivo | 11 | 917 | |
| other | Hypothyroidism | Endocrine disorders | Arm A: Nivo + Ipi | 219 | 916 | |
| other | Hypothyroidism | Endocrine disorders | Arm B: Nivo | 139 | 917 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Nivo + Ipi | 102 | 916 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Nivo | 84 | 917 |
1 to 10 of 758Source ClinicalTrials.gov
See all 758 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Nivo + Ipi | 122 | 916 |
| Total, all-cause mortality | Arm B: Nivo | 121 | 917 |
| Total, other adverse events | Arm A: Nivo + Ipi | 868 | 916 |
| Total, other adverse events | Arm B: Nivo | 844 | 917 |
| Total, serious adverse events | Arm A: Nivo + Ipi | 374 | 916 |
| Total, serious adverse events | Arm B: Nivo | 242 | 917 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Nivo + Ipi vs Arm B: Nivo: deaths from any cause | Trial comparisons |
| Arm A: Nivo + Ipi vs Arm B: Nivo: serious adverse events | Trial comparisons |
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.
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/NCT03068455
GET https://conductscience.org/api/trials/v1/NCT03068455/results?page=2