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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: CANCER,NOS

Treatments: Drug: Ipilimumab; Drug: Lirilumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714739

CA223-001

Details and patient eligibility

About

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.

Enrollment: 337 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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337 participants in 4 patient groups

Part 1

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Lirilumab

Part 2 and 3: Cohort Expansion

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Lirilumab

Part 4: Cohort Expansion

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Lirilumab

Part 5 and 6

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Lirilumab

Drug: Ipilimumab