A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Malignancies

Treatments: Biological: Cabiralizumab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03158272

CA025-001

Details and patient eligibility

About

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.

Enrollment: 19 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Performance status 0-1
• Adequate organ function
• Cohort M1, 2 and C1: Measurable disease
• Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor
• Cohort C2: Documented refractory or relapsed multiple myeloma
• Subjects must be refractory to or have relapsed after standard therapies, or have no known effective treatment

Exclusion Criteria:

• Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases
• Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)
• Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia

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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19 participants in 2 patient groups

Monotherapy

Experimental group

Description:

Cabiralizumab administered as a single agent intravenous formulation

Treatment:

Biological: Cabiralizumab

Combination Therapy

Experimental group

Description:

Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation

Treatment:

Biological: Cabiralizumab

Biological: Nivolumab