NCT02061761 is a Phase 1, PHASE2 clinical trial of BMS-986016 in Hematologic Neoplasms, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT02061761?

NCT02061761 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT02061761?

Interventions in NCT02061761: BMS-986016, BMS-936558.

What condition does NCT02061761 study?

NCT02061761 studies Hematologic Neoplasms.

Is NCT02061761 still recruiting?

NCT02061761 is currently completed. Last updated 24 March 2023.

Are results published for NCT02061761?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-24 · How we verify

NCT02061761

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies

Completed Phase 1, PHASE2 Results posted Last updated 24 March 2023

What this trial tests

Phase 1, PHASE2 trial testing BMS-986016 in Hematologic Neoplasms in 106 participants. Completed in 16 February 2022.

Timeline

13 March 2014

Primary endpoint
16 February 2022

16 February 2022

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	13 March 2014
Primary completion	16 February 2022
Estimated completion	16 February 2022
Sites	10 locations across Canada, United States

Drugs / interventions tested

BMS-986016 — full drug profile →
BMS-936558 — full drug profile →

Conditions studied

Hematologic Neoplasms — all drugs for Hematologic Neoplasms →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Hematologic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation Primary · From first dose to 100 days post last dose (Up to 51 months)

Number of participants with any grade adverse events (AEs), any grade serious adverse events (SAEs) and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. An 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.

AEs

Group	Value	95% CI
BMS-986016 20mg	3
BMS-986016 80mg	9
BMS-986016 800mg	5
BMS-986016 240mg	19
BMS-986016 80mg + Nivolumab	7
BMS-986016 240mg + Nivolumab	1
BMS-986016 160mg + Nivolumab	59

SAEs

Group	Value	95% CI
BMS-986016 20mg	1
BMS-986016 80mg	4
BMS-986016 800mg	2
BMS-986016 240mg	6
BMS-986016 80mg + Nivolumab	4
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	26

AEs leading to discontinuation

Group	Value	95% CI
BMS-986016 20mg	1
BMS-986016 80mg	2
BMS-986016 800mg	0
BMS-986016 240mg	1
BMS-986016 80mg + Nivolumab	1
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	9

Number of Participants Who Died Primary · From first dose to 135 days post last dose (Up to 52 months)

Number of participants who died due to any cause.

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	2
BMS-986016 800mg	1
BMS-986016 240mg	2
BMS-986016 80mg + Nivolumab	2
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	10

Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests Primary · From first dose to 30 days post last dose (Up to 49 months)

Number of participants with laboratory abnormalities in specific hepatic tests based on SI unit convention. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concur

ALT OR AST > 3XULN

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	0
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	5

ALT OR AST > 5XULN

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	0
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	1

ALT OR AST > 10XULN

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	0
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	1

ALT OR AST > 20XULN

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	0
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	1

TOTAL BILIRUBIN > 2XULN

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	1
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	1

ALP > 1.5XULN

Group	Value	95% CI
BMS-986016 20mg	1
BMS-986016 80mg	1
BMS-986016 800mg	0
BMS-986016 240mg	1
BMS-986016 80mg + Nivolumab	1
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	8

CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	0
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	2

CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS

Group	Value	95% CI
BMS-986016 20mg	0
BMS-986016 80mg	0
BMS-986016 800mg	0
BMS-986016 240mg	0
BMS-986016 80mg + Nivolumab	0
BMS-986016 240mg + Nivolumab	0
BMS-986016 160mg + Nivolumab	2

Objective Response Rate (ORR) - Part D Primary · From first dose date to the date of disease progression per investigator or the date of subsequent therapy, whichever occurs first (Up to approximately 95 months)

Investigator-assessed ORR per International Working Group (IWG 2007) response criteria for malignant lymphoma is defined as the number of participants with a best overall documented response (BOR) of either a complete response (CR) or partial response (PR). Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. \>= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions). Progressive disease: Any new lesion or increas

Group	Value	95% CI
HL Naive BMS-986016 160mg + Nivolumab	61.9	38.4 – 81.9
DLBCL BMS-986016 160mg + Nivolumab	6.7	0.2 – 31.9
HL Post I/O BMS-986016 160mg + Nivolumab	15.0	3.2 – 37.9

Duration of Response (DoR) - Part D Primary · From first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (Up to approximately 95 months)

Investigator-assessed DoR per International Working Group (IWG 2007)) response criteria for malignant lymphoma is defined as the time between the date of first documented response (complete response or partial response) to the date of the first objectively documented progression, or death due to any cause, whichever occurs first. Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. \>= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other

Group	Value	95% CI
HL Naive BMS-986016 160mg + Nivolumab	14.16	2.56 – NA
DLBCL BMS-986016 160mg + Nivolumab	NA	NA – NA
HL Post I/O BMS-986016 160mg + Nivolumab	6.37	1.84 – NA

BMS-986016 Maximum Observed Serum Concentration (Cmax) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 Maximum Observed Serum Concentration (Cmax). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period

Period 0, Cycle 1, Day 1 (P0C1D1)

Group	Value	95% CI
BMS-986016 20mg	3.697	± NA
BMS-986016 80mg	22.738	± NA
BMS-986016 800mg	224.802	± NA
BMS-986016 240mg	68.718	± NA
BMS-986016 80mg + Nivolumab	19.990	± NA
BMS-986016 240mg + Nivolumab	57.900	± NA
BMS-986016 160mg + Nivolumab	40.402	± NA

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	6.660	± NA
BMS-986016 80mg	31.917	± NA
BMS-986016 800mg	673.000	± NA
BMS-986016 240mg	116.419	± NA
BMS-986016 80mg + Nivolumab	44.532	± NA
BMS-986016 240mg + Nivolumab	149.000	± NA
BMS-986016 160mg + Nivolumab	88.196	± NA

P1C1D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	59.600	± NA
BMS-986016 160mg + Nivolumab	68.400	± NA

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	165.000	± NA
BMS-986016 160mg + Nivolumab	163.000	± NA

BMS-986016 Time of Maximum Observed Serum Concentration (Tmax) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 Time of Maximum Observed Serum Concentration (Tmax). Period 0 = treatment period Period 1 = Re-challenge period

Period 0, Cycle 1, Day 1 (P0C1D1)

Group	Value	95% CI
BMS-986016 20mg	0.97	0.97 – 0.97
BMS-986016 80mg	1.300	1.00 – 4.00
BMS-986016 800mg	4.167	1.00 – 24.00
BMS-986016 240mg	1.825	0.97 – 95.75
BMS-986016 80mg + Nivolumab	3.950	1.00 – 5.00
BMS-986016 240mg + Nivolumab	0.97	0.97 – 0.97
BMS-986016 160mg + Nivolumab	1.600	0.97 – 24.07

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	0.984	0.97 – 1.00
BMS-986016 80mg	10.975	1.37 – 20.58
BMS-986016 800mg	168.22	168.22 – 168.22
BMS-986016 240mg	1.233	0.97 – 23.87
BMS-986016 80mg + Nivolumab	1.017	1.00 – 4.00
BMS-986016 240mg + Nivolumab	1.000	1.00 – 1.00
BMS-986016 160mg + Nivolumab	3.467	0.92 – 46.45

P1C1D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	4.000	4.00 – 4.00
BMS-986016 160mg + Nivolumab	1.750	1.75 – 1.75

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	24.000	24.00 – 24.00
BMS-986016 160mg + Nivolumab	0.900	0.90 – 0.90

BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 Area under the concentration-time curve in one dosing interval (AUC(TAU)). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period

Period 0, Cycle 1, Day 1 (P0C1D1)

Group	Value	95% CI
BMS-986016 20mg	401.438	± NA
BMS-986016 80mg	2852.533	± NA
BMS-986016 800mg	44296.525	± NA
BMS-986016 240mg	9086.827	± NA
BMS-986016 80mg + Nivolumab	2908.011	± NA
BMS-986016 240mg + Nivolumab	9480.758	± NA
BMS-986016 160mg + Nivolumab	5327.954	± NA

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	712.408	± NA
BMS-986016 80mg	4898.034	± NA
BMS-986016 800mg	176405.369	± NA
BMS-986016 240mg	18783.970	± NA
BMS-986016 80mg + Nivolumab	6166.165	± NA
BMS-986016 240mg + Nivolumab	34573.957	± NA
BMS-986016 160mg + Nivolumab	20464.075	± NA

P1C1D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	11259.871	± NA
BMS-986016 160mg + Nivolumab	11433.253	± NA

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	38472.003	± NA
BMS-986016 160mg + Nivolumab	33919.259	± NA

BMS-986016 Concentration at the End of a Dosing Interval (Ctau) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 Concentration at the end of a dosing interval (Ctau). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period

Period 0, Cycle 1, Day 1 (P0C1D1)

Group	Value	95% CI
BMS-986016 20mg	0.158	± NA
BMS-986016 80mg	1.037	± NA
BMS-986016 800mg	75.589	± NA
BMS-986016 240mg	12.221	± NA
BMS-986016 80mg + Nivolumab	3.848	± NA
BMS-986016 240mg + Nivolumab	19.500	± NA
BMS-986016 160mg + Nivolumab	8.417	± NA

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	0.256	± NA
BMS-986016 80mg	2.266	± NA
BMS-986016 800mg	293.000	± NA
BMS-986016 240mg	30.970	± NA
BMS-986016 80mg + Nivolumab	9.556	± NA
BMS-986016 240mg + Nivolumab	103.000	± NA
BMS-986016 160mg + Nivolumab	47.016	± NA

P1C1D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	25.900	± NA
BMS-986016 160mg + Nivolumab	24.200	± NA

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	86.600	± NA
BMS-986016 160mg + Nivolumab	86.100	± NA

BMS-986016 Effective Elimination Half-life That Explains the Degree of AUC Accumulation Observed (T 1/2eff AUC) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 effective elimination half-life that explains the degree of AUC accumulation observed (t 1/2eff AUC). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	240.671	± 143.5338
BMS-986016 80mg	742.843	± NA
BMS-986016 800mg	547.986	± NA
BMS-986016 240mg	428.698	± 346.4046
BMS-986016 80mg + Nivolumab	548.741	± 78.0213
BMS-986016 240mg + Nivolumab	720.317	± NA
BMS-986016 160mg + Nivolumab	674.755	± 296.9473

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	638.597	± NA
BMS-986016 160mg + Nivolumab	524.637	± NA

BMS-986016 Total Body Clearance (CL/T) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 total body clearance (CL/T). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	28.074	± NA
BMS-986016 80mg	16.333	± NA
BMS-986016 800mg	4.535	± NA
BMS-986016 240mg	12.777	± NA
BMS-986016 80mg + Nivolumab	12.974	± NA
BMS-986016 240mg + Nivolumab	6.942	± NA
BMS-986016 160mg + Nivolumab	7.819	± NA

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	6.238	± NA
BMS-986016 160mg + Nivolumab	4.717	± NA

BMS-986016 Cmax Accumulation Index (AI_Cmax) Secondary · PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1

BMS-986016 cmax accumulation index (AI\_Cmax). AI is calculated based on ratio of Cmax at steady state to Cmax after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 - Re-challenge period

P0C3D1

Group	Value	95% CI
BMS-986016 20mg	1.981	± NA
BMS-986016 80mg	1.701	± NA
BMS-986016 800mg	2.009	± NA
BMS-986016 240mg	1.734	± NA
BMS-986016 80mg + Nivolumab	2.369	± NA
BMS-986016 240mg + Nivolumab	2.573	± NA
BMS-986016 160mg + Nivolumab	2.139	± NA

P1C3D1

Group	Value	95% CI
BMS-986016 240mg + Nivolumab	2.768	± NA
BMS-986016 160mg + Nivolumab	2.383	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Mono Esc 20 Q2W

Serious: 1/3 (33%)

Deaths: 2/3

All Mono Esc 80 Q2W

Serious: 5/9 (56%)

Deaths: 3/9

All Mono Esc 240 Q2W

Serious: 1/9 (11%)

Deaths: 0/9

All Mono Esc 800 Q2W

Serious: 2/6 (33%)

Deaths: 1/6

CLL BMS-986016 240mg

Serious: 1/2 (50%)

Deaths: 1/2

DLBCL BMS-986016 240mg

Serious: 2/2 (100%)

Deaths: 2/2

iNHL BMS-986016 240mg

Serious: 2/4 (50%)

Deaths: 0/4

HL BMS-986016 240mg

Serious: 1/3 (33%)

Deaths: 0/3

All Combo Esc 80/240 Q2W

Serious: 4/7 (57%)

Deaths: 5/7

All Combo Esc 160/240 Q2W

Serious: 2/4 (50%)

Deaths: 2/4

All Combo Esc 240/240 Q2W

Serious: 0/1 (0%)

Deaths: 0/1

HL Naive BMS-986016 160mg + Nivolumab

Serious: 6/21 (29%)

Deaths: 1/21

DLBCL BMS-986016 160mg + Nivolumab

Serious: 11/15 (73%)

Deaths: 13/15

HL Post I/O BMS-986016 160mg + Nivolumab

Serious: 9/20 (45%)

Deaths: 3/20

Serious adverse events (65 terms)

Reaction	System	All Mono Esc 20 Q2W	All Mono Esc 80 Q2W	All Mono Esc 240 Q2W	All Mono Esc 800 Q2W	CLL BMS-986016 240mg	DLBCL BMS-986016 240mg	iNHL BMS-986016 240mg	HL BMS-986016 240mg	All Combo Esc 80/240 Q2W	All Combo Esc 160/240 Q2W	All Combo Esc 240/240 Q2W	HL Naive BMS-986016 160mg …	DLBCL BMS-986016 160mg + N…	HL Post I/O BMS-986016 160…
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia of malignancy	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oesophageal spasm	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Autoimmune hepatitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (234 terms — click to expand)

Reaction	System	All Mono Esc 20 Q2W	All Mono Esc 80 Q2W	All Mono Esc 240 Q2W	All Mono Esc 800 Q2W	CLL BMS-986016 240mg	DLBCL BMS-986016 240mg	iNHL BMS-986016 240mg	HL BMS-986016 240mg	All Combo Esc 80/240 Q2W	All Combo Esc 160/240 Q2W	All Combo Esc 240/240 Q2W	HL Naive BMS-986016 160mg …	DLBCL BMS-986016 160mg + N…	HL Post I/O BMS-986016 160…
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diplopia	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Adrenal insufficiency, Acute kidney injury, Dyspnoea, Hypoxia, Anaemia, Neutropenia, Thrombocytopenia.

Data from ClinicalTrials.gov NCT02061761 adverse events section.

Sponsor's own description

The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Novel immune checkpoint targets: moving beyond PD-1 and CTLA-4.
Qin S, Xu L, Yi M, Yu S, et al · · 2019 · cited 909× · PMID 31690319 · DOI 10.1186/s12943-019-1091-2
LAG3 (CD223) as a cancer immunotherapy target.
Andrews LP, Marciscano AE, Drake CG, Vignali DA. · · 2017 · cited 754× · PMID 28258692 · DOI 10.1111/imr.12519
Regulatory T cells in tumor microenvironment: new mechanisms, potential therapeutic strategies and future prospects.
Li C, Jiang P, Wei S, Xu X, et al · · 2020 · cited 679× · PMID 32680511 · DOI 10.1186/s12943-020-01234-1
NK Cell-Based Immune Checkpoint Inhibition.
Khan M, Arooj S, Wang H. · · 2020 · cited 296× · PMID 32117298 · DOI 10.3389/fimmu.2020.00167
The promising immune checkpoint LAG-3: from tumor microenvironment to cancer immunotherapy.
Long L, Zhang X, Chen F, Pan Q, et al · · 2018 · cited 288× · PMID 30603054 · DOI 10.18632/genesandcancer.180
Mechanisms of action and rationale for the use of checkpoint inhibitors in cancer.
Granier C, De Guillebon E, Blanc C, Roussel H, et al · · 2017 · cited 252× · PMID 28761757 · DOI 10.1136/esmoopen-2017-000213
Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy.
Cai L, Li Y, Tan J, Xu L, et al · · 2023 · cited 232× · PMID 37670328 · DOI 10.1186/s13045-023-01499-1
Combining Immune Checkpoint Inhibitors: Established and Emerging Targets and Strategies to Improve Outcomes in Melanoma.
Khair DO, Bax HJ, Mele S, Crescioli S, et al · · 2019 · cited 181× · PMID 30941125 · DOI 10.3389/fimmu.2019.00453

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02061761 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 24 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02061761.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02061761

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (65 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of BMS-986016

Other recruiting trials for Hematologic Neoplasms

Other Bristol-Myers Squibb trials

Verify against primary sources