Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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
Last Update Posted : November 26, 2019
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 : 24 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 24, 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. Incidenence of Adverse Events (AEs) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of cabiralizumab as monotherapy in subjects with advanced solid tumors

  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of cabiralizumab as monotherapy in subjects with advanced solid tumors

  3. Incidence of laboratory abnormalities [ Time Frame: Up to two years ]
    To assess the safety and tolerability of cabiralizumab as monotherapy in subjects with advanced solid tumors

  4. Incidence of death [ Time Frame: Up to two years ]
    To assess the safety and tolerability of cabiralizumab as monotherapy in subjects with advanced solid tumors


Secondary Outcome Measures :
  1. Incidence of AEs [ Time Frame: Up to two years ]
    To assess the safety of cabiralizumab in combination with nivolumab in subjects with advanced solid tumors and hematologic malignancies

  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ]
    To assess the safety of cabiralizumab in combination with nivolumab in subjects with advanced solid tumors and hematologic malignancies

  3. Incidence of laboratory abnormalities [ Time Frame: Up to two years ]
    To assess the safety of cabiralizumab in combination with nivolumab in subjects with advanced solid tumors and hematologic malignancies

  4. Trough observed concentration (Ctrough) Accumulation Index; ratio of Ctrough at steady-state (AI_Ctrough) [ Time Frame: Up to one year ]
    Summary measures of pharmacokinetic (PK) parameters

  5. Area under the serum concentration-time curve from time zero to [AUC(0-T) [ Time Frame: Up to one year ]
    Summary measures of PK parameters

  6. Maximum observed serum concentration (Cmax) [ Time Frame: Up to one year ]
    Summary measures of PK parameters

  7. Trough observed serum concentration (Ctrough) [ Time Frame: Up to one year ]
    Summary of PK parameters

  8. Effective elimination half-life that explains the degree of Ctrough (T-HALFeff_Ctrough) [ Time Frame: Up to one year ]
    Summary measures of PK parameters

  9. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to one year ]
    Summary measures of PK parameters

  10. Volume of distribution at steady state (Vss) [ Time Frame: Up to one year ]
    Summary measures of PK parameters

  11. Incidence of Antidrug Antibodies (ADA) [ Time Frame: Up to four years ]
    To characterize the immunogenicity of cabiralizumab and nivolumab

  12. Best overall response (BOR) [ Time Frame: Up to two years ]
    Assessed per RECIST 1.1 or International Myeloma Working Group (IMWG) Response criteria

  13. Duration of response [ Time Frame: Up to two years ]
    Assessed per RECIST 1.1 or IMWG Response criteria

  14. Incidence of death [ Time Frame: Up to two years ]
    To assess the safety of cabiralizumab in combination with nivolumab in subjects with advanced solid tumors and hematologic malignancies



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
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
Last Update Posted: November 26, 2019
Last Verified: November 2019

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