A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: Lirilumab; Biological: Ipilimumab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03203876

CA223-030

Details and patient eligibility

About

The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
• The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

• Participants with untreated central nervous system (CNS) metastases
• Participants with an active, known, or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Part One Combination Therapy

Experimental group

Description:

Lirilumab and Nivolumab

Treatment:

Biological: Nivolumab

Biological: Lirilumab

Part 2 Combination Therapy

Experimental group

Description:

Lirilumab, Nivolumab and Ipilimumab

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Biological: Lirilumab