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

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ClinicalTrials.gov Identifier: NCT03158272
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : October 3, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : November 29, 2020
Estimated Study Completion Date : November 30, 2020

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



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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


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Locations
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4678602
Contact: Site 0003         
Local Institution Recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Contact: Site 0002         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03158272     History of Changes
Other Study ID Numbers: CA025-001
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

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:
Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs