Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CANCER,NOS | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Lirilumab | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1
- description
- Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
- interventionNames
- Drug: Lirilumab
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 2 and 3: Cohort Expansion
- description
- In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
- interventionNames
- Drug: Lirilumab
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 4: Cohort Expansion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen * During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens * Subjects must have measurable disease * Subject must consent to provide previously collected tumor tissue * Women and men ≥18 years of age with performance status of 0 or 1 * At least 4 weeks since any previous treatment for cancer Exclusion Criteria: * Active or chronic autoimmune diseases * Uncontrolled or significant cardiovascular disease * Chronic hepatitis (except for subjects with hepatocellular carcinoma) * Active infection * Active Central nervous system (CNS) metastases * Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS) * Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma) Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available