Trial · NCT03470922
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
NCT03470922, Phase 2, Phase 3, Active not recruiting, Bristol-Myers Squibb; results first posted 2022-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma. Trials, record NCT03470922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03470922
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
- NCT number
- NCT03470922
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 714 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Melanoma
- Interventions
- Relatlimab, Nivolumab
- First posted
- 2018-03-20
- Last updated
- 2025-09-09
- Results first posted
- 2022-03-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization to date of first documented tumor progression or death (up to approximately 33 months) | Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death. |
| Secondary | Overall Survival (OS) | From randomization to the date of death (up to approximately 3 years) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). |
| Secondary | Overall Response Rate (ORR) | From randomization up to approximately 3 years | Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria). |
| Other | The Number of Participants Experiencing Adverse Events (AEs) | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | The number of participants experiencing adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. |
| Other | The Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | The number of participants experiencing serious adverse events (SAEs). A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. |
| Other | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | The number of participants experiencing adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. |
| Other | The Number of Participant Deaths in the Study | From first dose up to approximately 33 months | The number of participant deaths in the study. |
| Other | The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units. |
| Other | The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From randomization to date of first documented tumor progression or death (up to approximately 33 months) | All randomized participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death (up to approximately 3 years) | |||
| SECONDARY | Overall Response Rate (ORR) | From randomization up to approximately 3 years | |||
| OTHER_PRE_SPECIFIED | The Number of Participants Experiencing Adverse Events (AEs) | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Number of Participant Deaths in the Study | From first dose up to approximately 33 months | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm A: Relatlimab + Nivolumab | 10.12 | 95% Confidence Interval 6.37 to 15.74 | Months | |
| Progression Free Survival (PFS) | Arm B: Nivolumab | 4.63 | 95% Confidence Interval 3.38 to 5.62 | Months | |
| The Number of Participants Experiencing Adverse Events (AEs) | Arm A: Relatlimab + Nivolumab | 345 | Participants | ||
| The Number of Participants Experiencing Adverse Events (AEs) | Arm B: Nivolumab | 339 | Participants | ||
| The Number of Participants Experiencing Serious Adverse Events (SAEs) | Arm A: Relatlimab + Nivolumab | 121 | Participants | ||
| The Number of Participants Experiencing Serious Adverse Events (SAEs) | Arm B: Nivolumab | 105 | Participants | ||
| The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Arm A: Relatlimab + Nivolumab | 69 | Participants | ||
| The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Arm B: Nivolumab | 41 | Participants | ||
| The Number of Participant Deaths in the Study | Arm A: Relatlimab + Nivolumab | 108 | Participants | ||
| The Number of Participant Deaths in the Study | Arm B: Nivolumab | 119 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Relatlimab + Nivolumab | 355 | |
| Overall Study | STARTED | Arm B: Nivolumab | 359 | |
| Overall Study | COMPLETED | Arm A: Relatlimab + Nivolumab | 237 | |
| Overall Study | COMPLETED | Arm B: Nivolumab | 227 | |
| Overall Study | NOT COMPLETED | Arm A: Relatlimab + Nivolumab | 118 | |
| Overall Study | NOT COMPLETED | Arm B: Nivolumab | 132 |
Source ClinicalTrials.gov
Adverse events556
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 | Anaemia | Blood and lymphatic system disorders | Arm A: Relatlimab + Nivolumab | 50 | 355 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Nivolumab | 37 | 359 | |
| other | Hyperthyroidism | Endocrine disorders | Arm A: Relatlimab + Nivolumab | 23 | 355 | |
| other | Hyperthyroidism | Endocrine disorders | Arm B: Nivolumab | 28 | 359 | |
| other | Hypothyroidism | Endocrine disorders | Arm A: Relatlimab + Nivolumab | 58 | 355 | |
| other | Hypothyroidism | Endocrine disorders | Arm B: Nivolumab | 47 | 359 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Relatlimab + Nivolumab | 31 | 355 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Nivolumab | 31 | 359 | |
| other | Constipation | Gastrointestinal disorders | Arm A: Relatlimab + Nivolumab | 39 | 355 | |
| other | Constipation | Gastrointestinal disorders | Arm B: Nivolumab | 25 | 359 |
1 to 10 of 556Source ClinicalTrials.gov
See all 556 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Relatlimab + Nivolumab | 108 | 355 |
| Total, all-cause mortality | Arm B: Nivolumab | 119 | 359 |
| Total, other adverse events | Arm A: Relatlimab + Nivolumab | 314 | 355 |
| Total, other adverse events | Arm B: Nivolumab | 298 | 359 |
| Total, serious adverse events | Arm A: Relatlimab + Nivolumab | 155 | 355 |
| Total, serious adverse events | Arm B: Nivolumab | 140 | 359 |
Source ClinicalTrials.gov
Papers9
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Trial comparisons |
| Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: The Number of Participants Experiencing Serious Adverse Events (SAEs) | Trial comparisons |
| Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: The Number of Participant Deaths in the Study | Trial comparisons |
| Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: deaths from any cause | Trial comparisons |
| Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: The Number of Participants Experiencing Adverse Events (AEs) | Trial comparisons |
| Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: 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/NCT03470922
GET https://conductscience.org/api/trials/v1/NCT03470922/results?page=2