Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158272
Recruitment Status : Completed
First Posted : May 18, 2017
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Biological: Cabiralizumab Biological: Nivolumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment will only in combination therapy arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies
Actual Study Start Date : May 25, 2017
Actual Primary Completion Date : October 23, 2019
Actual Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Monotherapy
Cabiralizumab administered as a single agent intravenous formulation
Biological: Cabiralizumab
Specified dose on specified days

Experimental: Combination Therapy
Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
Biological: Cabiralizumab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo




Primary Outcome Measures :
  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 Outcome Measures :
  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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158272


Locations
Layout table for location information
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4678602
Local Institution
Kamogawa-shi, Chiba, Japan, 2968602
Local Institution
Kashiwa-shi, Chiba, Japan, 2778577
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] September 10, 2019
Study Protocol  [PDF] March 22, 2018

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03158272    
Other Study ID Numbers: CA025-001
First Posted: May 18, 2017    Key Record Dates
Results First Posted: December 21, 2020
Last Update Posted: December 21, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action