A Study to Evaluate the Safety and Tolerability of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination with Nivolumab (BMS-936558) in Advanced Malignancies
Phase 1
Completed
- Conditions
- Advanced Malignancies
- Registration Number
- JPRN-jRCT2080223582
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Incidenence of Adverse Events (AEs) [ Time Frame: Up to two years ]<br>Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ]<br>Incidence of laboratory abnormalities [ Time Frame: Up to two years ]<br>Incidence of death [ Time Frame: Up to two years ]
- Secondary Outcome Measures
Name Time Method