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OpenTrials
Completed

NCT Number: NCT03158272

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

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.

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Key information

Conditions

Advanced Malignancies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabiralizumab

Biological

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy

    Time frame: From 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.

  2. Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy

    Time frame: From 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.

  3. Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy

    Time frame: 28 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.

  4. Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy

    Time frame: From 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.

  5. Number of Participants Who Died - Carbiralizumab Monotherapy

    Time frame: From 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.

  6. Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy

    Time frame: From 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.

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy

    Time frame: From 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.

  2. Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy

    Time frame: From 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.

  3. Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy

    Time frame: From 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.

  4. Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy

    Time frame: From 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.

  5. Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy

    Time frame: From 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

  6. AI_Ctrough

    Time frame: Cycle 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

  7. AUC(0-T)

    Time frame: 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.

  8. AUC(TAU)

    Time frame: 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.

  9. Cmax

    Time frame: 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.

    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.

  10. Ctrough

    Time frame: Cycles 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.

  11. T-HALFeff_Ctrough

    Time frame: Cycle 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.

  12. Tmax

    Time frame: 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.

    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.

  13. Incidence of Anti-drug Antibodies (ADA)

    Time frame: 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.

  14. Best Overall Response (BOR)

    Time frame: 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

  15. Duration of Response (DOR)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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