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A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03192943
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
17.6
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
Actual Study Start Date :
Jun 23, 2017
Actual Primary Completion Date :
Dec 11, 2018
Actual Study Completion Date :
Dec 11, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation

monotherapy and combination therapy

Drug: BMS-986205
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events (AEs) [15 months]

      Safety and Tolerability

    2. Incidence of Serious Adverse Events (SAEs) [15 months]

      Safety and Tolerability

    3. Incidence of Death [15 months]

      Safety and Tolerability

    4. Incidence of Laboratory Abnormalities [15 months]

      Safety and Tolerability

    5. AEs leading to discontinuation [Up to one year]

      Safety and Tolerability

    Secondary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to one year]

      To characterize the Pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab

    2. Time of maximum observed plasma concentration (Tmax) [Up to one year]

      To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

    3. Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] [Up to one year]

      To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

    4. Trough observed plasma concentration at the end of the dosing interval (Ctrough) [Up to one year]

      To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

    5. Apparent total body clearance (CLT/F) [Up to one year]

      To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

    6. Apparent volume of distribution at steady-state (Vss/F) [Up to one year]

      To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

    7. Percent urinary recovery over 24 hours (%UR24) [Up to 24 hours]

      To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

    8. Biomarker Availability [Up to one year]

      To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab

    9. Incidence of anti-drug antibody (ADA) [Up to one year]

      To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205

    10. Best Overall Response (BOR) [Up to one year]

      To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors

    11. Duration of Response (DOR) [Up to one year]

      To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

    • Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)

    • Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting

    • Eastern Cooperative Oncology Group performance status of ≤ 1

    Exclusion Criteria:

    • Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded

    • History of congenital or autoimmune hemolytic disorders

    • History or presence of hypersensitivity or idiosyncratic reaction to methylene blue

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Chuo-ku Tokyo Japan 1040045

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03192943
    Other Study ID Numbers:
    • CA017-048
    First Posted:
    Jun 20, 2017
    Last Update Posted:
    Apr 1, 2019
    Last Verified:
    Mar 1, 2019
    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:
    Nivolumab
    Linrodostat

    Study Results

    No Results Posted as of Apr 1, 2019