Phase 1
Completed N=19
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
Advanced Malignancies
Source: ClinicalTrials.gov NCT03158272 ↗
Enrolled (actual)
19
Serious AEs
52.6%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy — 3; 4 Number of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy |
3; 4 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy |
1; 2 | — |
| PRIMARY Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy |
0; 0 | — |
| PRIMARY Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy |
0; 1 | — |
| PRIMARY Number of Participants Who Died - Carbiralizumab Monotherapy |
0; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy |
3; 4; 2; 4; 1; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy |
6; 5 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy |
1; 1 | — |
| SECONDARY Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy |
1; 1 | — |
| SECONDARY Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy |
1; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy |
6; 6; 3; 5; 3; 1 | — |
| SECONDARY AI_Ctrough |
NA; NA | — |
| SECONDARY AUC(0-T) |
4992; 11668; 9969; 8723 | — |
| SECONDARY AUC(TAU) |
4992; 12499; 9969; 10590 | — |
| SECONDARY Cmax |
43.7; 91.4; 84.8; 76.2 | — |
| SECONDARY Ctrough |
2.44; 18.5; 10.1; 16.5; 4.70; 39.8 | — |
| SECONDARY T-HALFeff_Ctrough |
NA; NA | — |
| SECONDARY Tmax |
3.18; 0.546; 1.14; 1.32 | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADA) |
1; 0; 2; 0; NA; NA | — |
| SECONDARY Best Overall Response (BOR) |
2; 0; 3; 0; 1; 3 | — |
| SECONDARY Duration of Response (DOR) |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03158272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.