Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lirilumab · 3 trials · 3 indications
To assess the safety and tolerability of lirilumab in combination with nivolumab
To assess the safety and tolerability of lirilumab in combination with nivolumab
To assess the safety and tolerability of lirilumab in combination with nivolumab
To assess the safety and tolerability of lirilumab in combination with nivolumab
To assess the safety and tolerability of lirilumab in combination with nivolumab
To assess the safety and tolerability of lirilumab in combination with nivolumab
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.
The number of participants who died.
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.
| Arm | Type | Description |
|---|---|---|
| Part One Combination Therapy | EXPERIMENTAL | Lirilumab and Nivolumab |
| Part 2 Combination Therapy | EXPERIMENTAL | Lirilumab, Nivolumab and Ipilimumab |
| Arm 1: Lirilumab + Ipilimumab | EXPERIMENTAL | Lirilumab and Ipilimumab on specific days |
| Part 1 | EXPERIMENTAL | Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab |
| Part 2 and 3: Cohort Expansion | EXPERIMENTAL | In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab |
| Part 4: Cohort Expansion | EXPERIMENTAL | Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled) |
| Part 5 and 6 | EXPERIMENTAL | Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled) |
| Name | Type | Description |
|---|---|---|
| Lirilumab | BIOLOGICAL | Specified dose on specified days |
| Nivolumab | BIOLOGICAL | Specified dose on specified days |
| Ipilimumab | BIOLOGICAL | Specified dose on specified days |
Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com * Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable) * Presence of at least 1 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Lirilumab is an investigational monoclonal antibody being studied for the treatment of advanced cancer and cancer not otherwise specified. It is being evaluated in combination with other immunotherapies, including nivolumab and ipilimumab, in patients with advanced solid tumors. Lirilumab is not yet approved and remains in clinical development.
Lirilumab is an anti-KIR antibody, meaning it targets killer-cell immunoglobulin-like receptors (KIR) on natural killer cells. By blocking these receptors, Lirilumab is designed to enhance the activity of natural killer cells against tumors. It is being studied in combination with checkpoint inhibitors like nivolumab and ipilimumab.
Lirilumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of Lirilumab in combination with other immunotherapies for the treatment of advanced solid tumors.
Lirilumab is in Phase 1 clinical development. All three clinical trials listed for Lirilumab are Phase 1 studies and have been completed. The drug is investigational and has not received FDA approval. It is being studied in combination with nivolumab and ipilimumab in patients with advanced cancer.
Lirilumab has been studied in three completed Phase 1 trials: NCT01714739, which enrolled 337 patients with advanced solid tumors; NCT01750580, which enrolled 22 patients with selected advanced tumors; and NCT03203876, which enrolled 10 patients in Japan with advanced or metastatic solid tumors. All trials evaluated Lirilumab in combination with nivolumab and/or ipilimumab.
Yes, Lirilumab is also known as BMS-986015. One clinical trial, NCT01750580, refers to the drug as BMS-986015 (Anti-KIR) in its title. Both names refer to the same investigational anti-KIR monoclonal antibody being developed by Bristol-Myers Squibb.