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An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03745807
Collaborator
Nektar Therapeutics (Industry), Ono Pharmaceutical Co. Ltd (Industry)
3
Enrollment
1
Location
1
Arm
8.3
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.

Condition or Disease Intervention/Treatment Phase
  • Biological: NKTR-214
  • Biological: Nivolumab
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study to Evaluate Safety and Tolerability of NKTR-214 (BMS-986321) Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
Actual Study Start Date :
Apr 9, 2019
Actual Primary Completion Date :
Dec 18, 2019
Actual Study Completion Date :
Dec 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination

NKTR-214 + nivolumab

Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin
  • BMS-986321

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [Approximately 2 years]

    2. Incidence of serious adverse events (SAEs) [Approximately 2 years]

    3. Incidence of AEs leading to discontinuation [Approximately 2 years]

    4. Incidence of deaths [Approximately 2 years]

    5. Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [Approximately 2 years]

    6. Incidence of laboratory abnormalities [Approximately 2 years]

    Secondary Outcome Measures

    1. Maximum observed concentration (Cmax) [Approximately 2 years]

    2. Time of maximum observed concentration (Tmax) [Approximately 2 years]

    3. Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Approximately 2 years]

    4. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [Approximately 2 years]

    5. Total body clearance (CLT) [Approximately 2 years]

    6. Volume of distribution (Vz) [Approximately 2 years]

    7. Apparent terminal phase half-life (T-HALF) [Approximately 2 years]

    8. Trough observed serum concentration at the end of the dosing interval (Ctrough) [Approximately 2 years]

    9. Incidence of anti-drug antibodies (ADA) to NKTR-214 [Approximately 2 years]

    10. Incidence of anti-drug antibodies (ADA) to nivolumab [Approximately 2 years]

    11. Best overall response (BOR) [Approximately 2 years]

    12. Duration of response (DOR) [Approximately 2 years]

    Eligibility Criteria

    Criteria

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

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

    Inclusion Criteria:

    • Histologic or cytological confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor with measurable disease per RECIST v1.1.

    • Life expectancy >12 weeks.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    Exclusion Criteria:

    • Active, known or suspected autoimmune disease.

    • History of organ transplant that requires use of immune suppressive agents.

    • Prior surgery or radiotherapy within 14 days of Cycle 1 Day 1. Participants must have recovered from all radiation-related, toxicities and not requiring corticosteroids.

    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
    • Nektar Therapeutics
    • Ono Pharmaceutical Co. Ltd

    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:
    NCT03745807
    Other Study ID Numbers:
    • CA045-010
    • 18-214-14
    First Posted:
    Nov 19, 2018
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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

    Study Results

    No Results Posted as of Oct 4, 2021