Trial · NCT01968109
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
NCT01968109, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2026-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors. Trials, record NCT01968109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968109
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
- NCT number
- NCT01968109
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 1,482 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Neoplasms by Site
- Interventions
- Relatlimab, Nivolumab, BMS-986213
- First posted
- 2013-10-23
- Last updated
- 2026-04-06
- Results first posted
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | From first dose and within 135 days after last dose of study therapy (Up to approximately 82 months) | 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. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. |
| Primary | Part C, D1, D2, E - Objective Response Rate Per BICR | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Primary | Part C, D1, D2, E - Disease Control Rate (DCR) Per BICR | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the percentage of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Primary | Part C, D1, D2, E - Duration of Response (DOR) Per BICR | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Primary | Part D1: Number of Participants With Adverse Events in the Broad Scope Standardized MedDRA (SMQ) Anaphylactic Reaction Occurring Within 2 Days of Any Doses of Study Therapy | From first dose and within 2 days of first dose of study therapy | 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. |
| Primary | Part C, D1, D2, E - Objective Response Rate Per BICR | From first dose (Day 1) and up to 97 months | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Part C, D1 and D2: Progression-Free Survival (PFS) Rate Per BICR | Up to 12 months | Progression Free Survival Rates at 12 months is defined as the proportion of participants who achieve PFS at 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Part D1 and D2: Overall Survival (OS) at 12 and 24 Months | At 12 and 24 months after first dose | Overall survival at 1 year, and 2 years is defined as the proportion of participants who are alive at 1 year, and 2 years. Based on Kaplan-Meier Estimates. |
| Secondary | Part C, D1, D2, E - Objective Response Rate Per Investigator | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Part C, D1, D2, E - Disease Control Rate (DCR) Per Investigator | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the percentage of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | From first dose and within 135 days after last dose of study therapy (Up to approximately 82 months) | All treated participants included all who received either study drug (BMS-986016 or Nivolumab). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part C, D1, D2, E - Objective Response Rate Per BICR | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Response-evaluable population include all participants in Parts C, D1, D2 and E who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part C, D1, D2 and E. | percentage of participants | NUMBER |
| PRIMARY | Part C, D1, D2, E - Disease Control Rate (DCR) Per BICR | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Response-evaluable population include all participants in Parts C, D1, D2 and E who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part C, D1, D2 and E. | percentage of participants | NUMBER |
| PRIMARY | Part C, D1, D2, E - Duration of Response (DOR) Per BICR | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Response Evaluable Participants in Part C, D1, D2, E. Only participants with CR or PR were included in the analysis. Pre-specified to be only collected for Part C, D1, D2 and E. | months | MEDIAN |
| PRIMARY | Part D1: Number of Participants With Adverse Events in the Broad Scope Standardized MedDRA (SMQ) Anaphylactic Reaction Occurring Within 2 Days of Any Doses of Study Therapy | From first dose and within 2 days of first dose of study therapy | All treated participants included all who received either study drug (BMS-986016 or Nivolumab). Pre-specified to be only collected for Part D1 participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part C, D1, D2, E - Objective Response Rate Per BICR | From first dose (Day 1) and up to 97 months | Response-evaluable population include all participants in Parts C, D1, D2, and E who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part C, D1, D2 and E. Only participants with data available at the timepoint were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Part C, D1 and D2: Progression-Free Survival (PFS) Rate up to 12 Months Per BICR | Up to 12 months | Response-evaluable population include all participants in Parts C, D1, and D2 who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part C, D1 and D2. Only participants with data available are included in the analysis. | proportion of participants | NUMBER |
| SECONDARY | Part D1 and D2: Overall Survival (OS) at 12 and 24 Months | At 12 and 24 months after first dose | Response-evaluable population include all participants in Parts C, D, and E who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part D1 and D2. | proportion of participants | NUMBER |
| SECONDARY | Part C, D1, D2, E - Objective Response Rate Per Investigator | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Response-evaluable population include all participants in Parts C, D1, D2, and E who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part C, D1, D2 and E. | percentage of participants | NUMBER |
| SECONDARY | Part C, D1, D2, E - Disease Control Rate (DCR) Per Investigator | From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months) | Response-evaluable population include all participants in Parts C, D1, D2, and E who had a baseline tumor assessment, and one of the following: (1) at least one evaluable on-treatment tumor assessment, (2) clinical progression, or (3) death. Pre-specified to be only collected for Part C, D1, D2 and E. | percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group739
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | BMS-986016 (Relatlimab) Monotherapy 20 Milligram (mg) (Part A) | Adverse Events | 5 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | BMS-986016 (Relatlimab) Monotherapy 80 Milligram (mg) (Part A) | Adverse Events | 4 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | BMS-986016 (Relatlimab) Monotherapy 240 Milligram (mg) (Part A) | Adverse Events | 4 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | BMS-986016 (Relatlimab) Monotherapy 800 Milligram (mg) (Part A/A1) | Adverse Events | 12 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | Combination-Escalation-BMS-986016 (Relatlimab)/Nivolumab (20 mg/80 mg) (Part B) | Adverse Events | 7 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (20 mg/240 mg (Part B) | Adverse Events | 9 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (80 mg/240 mg) (Part B) | Adverse Events | 8 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/240 mg) (Part B) | Adverse Events | 8 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (240 mg/240 mg) (Part B) | Adverse Events | 8 | Participants | |
| Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/480 mg) (Part B) | Adverse Events | 7 | Participants |
1 to 10 of 739Source ClinicalTrials.gov
See all 739 results by groupParticipant flow93
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BMS-986016 (Relatlimab) Monotherapy 20 Milligram (mg) (Part A) | 5 | |
| Overall Study | STARTED | BMS-986016 (Relatlimab) Monotherapy 80 Milligram (mg) (Part A) | 4 | |
| Overall Study | STARTED | BMS-986016 (Relatlimab) Monotherapy 240 Milligram (mg) (Part A) | 4 | |
| Overall Study | STARTED | BMS-986016 (Relatlimab) Monotherapy 800 Milligram (mg) (Part A/A1) | 12 | |
| Overall Study | STARTED | Combination-Escalation-BMS-986016 (Relatlimab)/Nivolumab (20 mg/80 mg) (Part B) | 7 | |
| Overall Study | STARTED | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (20 mg/240 mg (Part B) | 9 | |
| Overall Study | STARTED | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (80 mg/240 mg) (Part B) | 8 | |
| Overall Study | STARTED | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/240 mg) (Part B) | 8 | |
| Overall Study | STARTED | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (240 mg/240 mg) (Part B) | 8 | |
| Overall Study | STARTED | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/480 mg) (Part B) | 8 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 participant flowAdverse events30,600
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 | BMS-986016 (Relatlimab) Monotherapy 20 Milligram (mg) (Part A) | 2 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986016 (Relatlimab) Monotherapy 80 Milligram (mg) (Part A) | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986016 (Relatlimab) Monotherapy 240 Milligram (mg) (Part A) | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986016 (Relatlimab) Monotherapy 800 Milligram (mg) (Part A) | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986016 (Relatlimab) Expansion (NSCLC) 800 mg (Part A1) | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986016 (Relatlimab) Expansion (RCC) 800 mg (Part A1) | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Combination-Escalation-BMS-986016 (Relatlimab)/Nivolumab (20 mg/80 mg) (Part B) | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (20 mg/240 mg (Part B) | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (80 mg/240 mg) (Part B) | 3 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/240 mg) (Part B) | 1 | 8 |
1 to 10 of 30,600Source ClinicalTrials.gov
See all 30,600 adverse eventsAdverse event totals102
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS-986016 (Relatlimab) Monotherapy 20 Milligram (mg) (Part A) | 5 | 5 |
| Total, all-cause mortality | BMS-986016 (Relatlimab) Monotherapy 80 Milligram (mg) (Part A) | 3 | 4 |
| Total, all-cause mortality | BMS-986016 (Relatlimab) Monotherapy 240 Milligram (mg) (Part A) | 4 | 4 |
| Total, all-cause mortality | BMS-986016 (Relatlimab) Monotherapy 800 Milligram (mg) (Part A) | 3 | 4 |
| Total, all-cause mortality | BMS-986016 (Relatlimab) Expansion (NSCLC) 800 mg (Part A1) | 4 | 4 |
| Total, all-cause mortality | BMS-986016 (Relatlimab) Expansion (RCC) 800 mg (Part A1) | 4 | 4 |
| Total, all-cause mortality | Combination-Escalation-BMS-986016 (Relatlimab)/Nivolumab (20 mg/80 mg) (Part B) | 5 | 7 |
| Total, all-cause mortality | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (20 mg/240 mg (Part B) | 7 | 9 |
| Total, all-cause mortality | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (80 mg/240 mg) (Part B) | 6 | 8 |
| Total, all-cause mortality | Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/240 mg) (Part B) | 7 | 8 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse event totalsPapers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01968109
GET https://conductscience.org/api/trials/v1/NCT01968109/results?page=2