Clinical trial NCT03158272: A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
Official title: A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-05-18
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment will only in combination therapy arm.
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy
timeFrame: 28 days (from first day of treatment)
measure: Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants Who Died - Carbiralizumab Monotherapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
timeFrame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
measure: AI_Ctrough
timeFrame: Cycle 2 (pre-dose), Cycle 8 (pre-dose)
measure: AUC(0-T)
timeFrame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
measure: AUC(TAU)
timeFrame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
measure: Cmax
timeFrame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
measure: Ctrough
timeFrame: Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9
measure: T-HALFeff_Ctrough
timeFrame: Cycle 2 (pre-dose), Cycle 8 (pre-dose)
measure: Tmax
timeFrame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
measure: Incidence of Anti-drug Antibodies (ADA)
timeFrame: Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21
measure: Best Overall Response (BOR)
timeFrame: From first dose to end of follow-up, assessed up to July 2019, approximately 24 months
measure: Duration of Response (DOR)
timeFrame: From first dose to end of follow-up
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Kamogawa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: