Clinical trial · Interventional
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies
NCT03158272CI-TRIAL-00049035completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabiralizumab | Biological | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy
- description
- Cabiralizumab administered as a single agent intravenous formulation
- interventionNames
- Biological: Cabiralizumab
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
- interventionNames
- Biological: Cabiralizumab
- Biological: Nivolumab
Primary outcomes (6)
- measure
- Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.