Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antibodies

Ipilimumab

Immunoglobulins

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunologic Factors

Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab

In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab

Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)

Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)

Lirilumab

Bristol-Myers Squibb

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.

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

A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors

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.

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.

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.

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.

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.

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 (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.

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 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.

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.

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.

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.

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 assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.

Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.

Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment

Baseline ADA Positive Participant: A participant with baseline ADA positive sample.

ADA Positive Participant: Participant with \>=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer \>= 9-fold for Lirilumab and \>= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.

ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.

The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show \>=1% or \>= 5% PD-L1 expression in the tumor cell membrane and negative if they show \< 1% or \< 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).

PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.

PDL1= programmed cell death ligand 1

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.

Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.

Part 1/2 Liri 0.1 + Nivo 3

Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.

Part 1/2: Liri 0.3 + Nivo 3

Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.

Part 1/2: Liri 1 + Nivo 3

Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.

Part 1/2: Liri 3 + Nivo 3

Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.

Part 3: PBO + Nivo 240

Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.

Part 3: Liri 240 + Nivo 240

Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease

Part 5: Liri 3 + Nivo 3 + Ipi 1

Total

Age, Continuous

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Bristol-Myers Squibb Study Director

All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.

Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5

Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5

Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5

The Number of Participant Deaths in the Study - Parts 1, 2 and 5

Absolute Neutrophil Count - Grade 3

Absolute Neutrophil Count - Grade 4

Alanine Amino Transferase (ALT) - Grade 3

Alanine Amino Transferase (ALT) - Grade 4

Albumin - Grade 3

Albumin - Grade 4

Alkaline Phosphatase (ALP) - Grade 3

Alkaline Phosphatase (ALP) - Grade 4

Amylase, Total - Grade 3

Amylase, Total - Grade 4

APTT - Grade 3

APTT - Grade 4

Aspartate Aminotransferase (AST) - Grade 3

Aspartate Aminotransferase (AST) - Grade 4

Bilirubin, Total - Grade 3

Bilirubin, Total - Grade 4

Calcium, Corrected - Grade 3

Calcium, Corrected - Grade 4

Calcium, Ionized - Grade 3

Calcium, Ionized - Grade 4

Calcium, Total - Grade 3

Calcium, Total - Grade 4

Creatine Kinase (CK) - Grade 3

Creatine Kinase (CK) - Grade 4

Creatinine - Grade 3

Creatinine - Grade 4

Fibrinogen - Grade 3

Fibrinogen - Grade 4

G-Glutamyl Transferase (GGT) - Grade 3

G-Glutamyl Transferase (GGT) - Grade 4

Glucose, Fasting Serum - Grade 3

Glucose, Fasting Serum - Grade 4

Glucose, Serum - Grade 3

Glucose, Serum - Grade 4

Hemoglobin - Grade 3

Hemoglobin - Grade 4

Leukocytes - Grade 3

Leukocytes - Grade 4

Lipase, Total (Colorimetric Assay) - Grade 3

Lipase, Total (Colorimetric Assay) - Grade 4

Lipase, Total (Turbidimetric Assay) - Grade 3

Lipase, Total (Turbidimetric Assay) - Grade 4

Lymphocytes (Absolute) - Grade 3

Lymphocytes (Absolute) - Grade 4

Magnesium, Serum - Grade 3

Magnesium, Serum - Grade 4

Neutrophils (Absolute) - Grade 3

Neutrophils (Absolute) - Grade 4

pH, Arterial Blood - Grade 3

pH, Arterial Blood - Grade 4

Phosphorus, Inorganic - Grade 3

Phosphorus, Inorganic - Grade 4

Platelet Count - Grade 3

Platelet Count - Grade 4

Potassium, Serum - Grade 3

Potassium, Serum - Grade 4

Sodium Serum - Grade 3

Sodium Serum - Grade 4

All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Parts 1, 2 and 5.

Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5

Objective Response Rate (ORR)

All treated participants. Pre-specified for data to be collected only in Part 3.

Disease Control Rate (DCR) - Part 3

All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Parts 3 and 5.

Median Duration of Response (mDOR) - Parts 3 and 5

All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Part 3.

Median Time to Response (mTTR) - Part 3

WITH >=50% TUMOR REDUCTION

WITH >=80% TUMOR REDUCTION

All treated participants. Pre-specified for data to be collected only in Parts 3 and 5.

The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5

Overall Survival (OS) - Part 3

Progression Free Survival (PFS) - Part 3

Progression Free Survival Rate (PFSR) at 6 Months - Part 3

Number of Participants With Adverse Events (AEs) - Part 3

Number of Participants With Serious Adverse Events (SAEs) - Part 3

Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3

The Number of Participant Deaths in the Study - Part 3

All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Part 3.

Number of Participants With Clinical Laboratory Test Abnormalities - Part 3

Baseline ADA Positive - Liri

ADA Positive - Liri

ADA Negative - Liri

Baseline ADA Positive - Nivo

ADA Positive - Nivo

ADA Negative - Nivo

Baseline ADA Positive - Ipi

ADA Positive - Ipi

ADA Negative - Ipi

All participants who receive at least 1 dose of drug and have at least 1 ADA sample available. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5

PD-L1 1 percent - positive

PD-L1 1 percent - negative

PD-L1 5 percent - positive

PD-L1 5 percent - negative

All treated participants with available archival tumor sample and with pre- and on-treatment biopsies. Pre-specified for data to be collected only in Parts 1, 2, and 5.

The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5

Cycle 1

Cycle 2

All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5

Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5

Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5

Half-life (T-HALF) - Parts 1, 2 and 5

Clearance Per Time (CLT) - Parts 1, 2 and 5

Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5

All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5

Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5

Cycle 1 Day 1

Cycle 2 Day 29

End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)

Cycle 1 Day 29

Ctrough - Parts 1, 2 and 5 (Liri)

All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT01714739	CANCER,NOS	Lirilumab Nivolumab Ipilimumab	18 Years -	Bristol-Myers Squibb
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	NCT01714739	CANCER,NOS	Lirilumab Nivolumab Ipilimumab	18 Years -	Bristol-Myers Squibb
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	NCT01714739	CANCER,NOS	Lirilumab Nivolumab Ipilimumab	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for cancer,nos

Every month we try and update this database with for cancer,nos cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cancer,nos

Every month we try and update this database with for cancer,nos cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cancer,nos cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.