A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors
CompletedPhase 1, PHASE2Results postedLast updated 2 February 2023
What this trial tests
Phase 1, PHASE2 trial testing Lirilumab in CANCER,NOS in 337 participants. Completed in 13 December 2019.
18 and older, any sex, with CANCER,NOS. 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) - Parts 1, 2 and 5Primary· From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
4
Part 1/2: Liri 0.3 + Nivo 3
16
Part 1/2: Liri 1 + Nivo 3
15
Part 1/2: Liri 3 + Nivo 3
284
Part 5: Liri 3 + Nivo 3 + Ipi 1
10
Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5Primary· From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
A Serious Adverse Event (SAE) is 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, or is an important medical event.
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
1
Part 1/2: Liri 0.3 + Nivo 3
8
Part 1/2: Liri 1 + Nivo 3
9
Part 1/2: Liri 3 + Nivo 3
205
Part 5: Liri 3 + Nivo 3 + Ipi 1
7
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5Primary· From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
1
Part 1/2: Liri 0.3 + Nivo 3
1
Part 1/2: Liri 1 + Nivo 3
4
Part 1/2: Liri 3 + Nivo 3
49
Part 5: Liri 3 + Nivo 3 + Ipi 1
5
The Number of Participant Deaths in the Study - Parts 1, 2 and 5Primary· From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
The number of participants who died.
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
2
Part 1/2: Liri 0.3 + Nivo 3
7
Part 1/2: Liri 1 + Nivo 3
5
Part 1/2: Liri 3 + Nivo 3
219
Part 5: Liri 3 + Nivo 3 + Ipi 1
5
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5Primary· From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
Absolute Neutrophil Count - Grade 3
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
0
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
2
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Absolute Neutrophil Count - Grade 4
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
1
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
0
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Alanine Amino Transferase (ALT) - Grade 3
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
0
Part 1/2: Liri 1 + Nivo 3
1
Part 1/2: Liri 3 + Nivo 3
0
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Alanine Amino Transferase (ALT) - Grade 4
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
0
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
0
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Albumin - Grade 3
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
0
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
1
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Albumin - Grade 4
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
0
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
0
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Alkaline Phosphatase (ALP) - Grade 3
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
1
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
6
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Alkaline Phosphatase (ALP) - Grade 4
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
0
Part 1/2: Liri 0.3 + Nivo 3
0
Part 1/2: Liri 1 + Nivo 3
0
Part 1/2: Liri 3 + Nivo 3
0
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Objective Response Rate (ORR)Primary· From first dose up to approximately 2.5 years
Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Part 1/2 Liri 0.1 + Nivo 3
25.0
0.6 – 80.6
Part 1/2: Liri 0.3 + Nivo 3
37.5
15.2 – 64.6
Part 1/2: Liri 1 + Nivo 3
40.0
16.3 – 67.7
Part 1/2: Liri 3 + Nivo 3
14.6
10.8 – 19.3
Part 3: PBO + Nivo 240
50.0
1.3 – 98.7
Part 3: Liri 240 + Nivo 240
0
0.0 – 70.8
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
0.0 – 30.8
Disease Control Rate (DCR) - Part 3Secondary· From first dose up to approximately 2.5 years
Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease
Group
Value
95% CI
Part 3: PBO + Nivo 240
50.0
1.3 – 98.7
Part 3: Liri 240 + Nivo 240
33.3
0.8 – 90.6
Median Duration of Response (mDOR) - Parts 3 and 5Secondary· From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
DOR is defined as the time from the date of first response (CR or PR) to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any
Group
Value
95% CI
Part 3: PBO + Nivo 240
NA
40.0 – 40.0
Median Time to Response (mTTR) - Part 3Secondary· From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)
TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Part 3: PBO + Nivo 240
8.10
8.1 – 8.1
The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5Secondary· From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)
Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with \>= 50% and \>= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.
WITH >=50% TUMOR REDUCTION
Group
Value
95% CI
Part 3: PBO + Nivo 240
1
Part 3: Liri 240 + Nivo 240
2
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
WITH >=80% TUMOR REDUCTION
Group
Value
95% CI
Part 3: PBO + Nivo 240
0
Part 3: Liri 240 + Nivo 240
1
Part 5: Liri 3 + Nivo 3 + Ipi 1
0
Overall Survival (OS) - Part 3Secondary· From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)
Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.
Group
Value
95% CI
Part 3: PBO + Nivo 240
NA
0.2 – 1.2
Part 3: Liri 240 + Nivo 240
0.3
0.1 – 0.8
Progression Free Survival (PFS) - Part 3Secondary· From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor a
Group
Value
95% CI
Part 3: PBO + Nivo 240
NA
1.1 – 11.0
Part 3: Liri 240 + Nivo 240
1.6
1.1 – 7.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1/2 Liri 0.1 + Nivo 3
Serious: 1/4 (25%)
Deaths: 2/4
Part 1/2: Liri 0.3 + Nivo 3
Serious: 8/16 (50%)
Deaths: 7/16
Part 1/2: Liri 1 + Nivo 3
Serious: 9/15 (60%)
Deaths: 5/15
Part 1/2: Liri 3 + Nivo 3
Serious: 205/287 (71%)
Deaths: 219/287
Part 3: PBO + Nivo 240
Serious: 2/2 (100%)
Deaths: 1/2
Part 3: Liri 240 + Nivo 240
Serious: 3/3 (100%)
Deaths: 3/3
Part 5: Liri 3 + Nivo 3 + Ipi 1
Serious: 7/10 (70%)
Deaths: 5/10
Serious adverse events (190 terms)
Reaction
System
Part 1/2 Liri 0.1 + Nivo 3
Part 1/2: Liri 0.3 + Nivo 3
Part 1/2: Liri 1 + Nivo 3
Part 1/2: Liri 3 + Nivo 3
Part 3: PBO + Nivo 240
Part 3: Liri 240 + Nivo 240
Part 5: Liri 3 + Nivo 3 + …
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Dyspnoea
Respiratory, thoracic and mediastinal disorders
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Pyrexia
General disorders
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Anaemia
Blood and lymphatic system disorders
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Pneumonia
Infections and infestations
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Sepsis
Infections and infestations
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Infusion related reaction
Injury, poisoning and procedural complications
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General physical health deterioration
General disorders
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Hypercalcaemia
Metabolism and nutrition disorders
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Dysphagia
Gastrointestinal disorders
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Colitis
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Haemoptysis
Respiratory, thoracic and mediastinal disorders
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Lung disorder
Respiratory, thoracic and mediastinal disorders
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Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
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Diarrhoea
Gastrointestinal disorders
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Face oedema
General disorders
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Dehydration
Metabolism and nutrition disorders
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Pneumonitis
Respiratory, thoracic and mediastinal disorders
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Respiratory distress
Respiratory, thoracic and mediastinal disorders
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Respiratory failure
Respiratory, thoracic and mediastinal disorders
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Small intestinal obstruction
Gastrointestinal disorders
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Vomiting
Gastrointestinal disorders
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Hypokalaemia
Metabolism and nutrition disorders
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Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Hypoxia
Respiratory, thoracic and mediastinal disorders
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Other adverse events (278 terms — click to expand)
To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03347123 — A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Ma
· Phase 1, PHASE2
· terminated
NCT03341936 — Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN
· Phase 2
· active not recruiting
NCT03203876 — A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced an
· Phase 1
· completed
NCT02599649 — Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
· Phase 2
· terminated
NCT02481297 — Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
· Phase 2
· completed
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NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
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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: 2 February 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/NCT01714739.