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

Phase 1
Completed
Conditions
Advanced Malignancies
Interventions
Biological: Cabiralizumab
Biological: Nivolumab
Registration Number
NCT03158272
Lead Sponsor
Bristol-Myers Squibb
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
19
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
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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MonotherapyCabiralizumabCabiralizumab administered as a single agent intravenous formulation
Combination TherapyCabiralizumabCabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
Combination TherapyNivolumabCabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
Primary Outcome Measures
NameTimeMethod
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab MonotherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With Laboratory Abnormalities - Carbiralizumab MonotherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With Adverse Events (AEs) - Carbiralizumab MonotherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants Who Died - Carbiralizumab MonotherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab MonotherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy28 days (from first day of treatment)

The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.

Secondary Outcome Measures
NameTimeMethod
CmaxCycle 1 (from Day 1 pre-dose to Day 8, 168 hour)

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

Cmax is defined as the maximum observed serum concentration.

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo TherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an AE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.

Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo TherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab and nivolumab combination therapy.

Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination TherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced a laboratory abnormality during the course of the study while participating in carbiralizumab and nivolumab combination therapy

Duration of Response (DOR)From first dose to end of follow-up

To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies).

IMWG: International Myeloma Working Group

RECIST: Response Evaluation Criteria in Solid Tumors

Duration of response (DOR) was listed for participants with a BOR of complete response (CR) or partial response (PR).

CtroughCycles 1, 2, 3, 4, 5, 6, 7, 8, 9

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

Ctrough is defined as the Trough observed serum concentration (predose at each cycle).

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

T-HALFeff_CtroughCycle 2 (pre-dose), Cycle 8 (pre-dose)

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

T-HALFeff_Ctrough is defined as the effective elimination half-life that explains the degree of Ctrough accumulation observed.

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo TherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an SAE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.

Number of Participants Who Died - Carbiralizumab and Nivolumab Combo TherapyFrom first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that died during the course of the study while participating in cabiralizumab and nivolumab combination therapy.

AUC(0-T)Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

AUC(0-T) is defined as the area under the serum concentration-time curve from time zero to time of last quantifiable concentration after the first dose.

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

TmaxCycle 1 (from Day 1 pre-dose to Day 8, 168 hour)

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

Tmax is defined as the time of maximum observed serum concentration.

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

Best Overall Response (BOR)From first dose to end of follow-up, assessed up to July 2019, approximately 24 months

To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies).

IMWG: International Myeloma Working Group

RECIST: Response Evaluation Criteria in Solid Tumors

AI_CtroughCycle 2 (pre-dose), Cycle 8 (pre-dose)

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

Ctrough Accumulation Index; ratio of Ctrough at steady-state (i.e. Cycle 8) to Ctrough after the first dose

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

AI = Ctrough on cycle 8 / Ctrough on Cycle 2

AUC(TAU)Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)

Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.

AUC(TAU) is defined as the area under the serum concentration-time curve in one dosing interval.

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

Incidence of Anti-drug Antibodies (ADA)Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21

To characterize the immunogenicity of cabiralizumab and nivolumab.

Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.

Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.

Trial Locations

Locations (1)

Local Institution

🇯🇵

Chuo-ku, Tokyo, Japan

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