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An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03446040
Collaborator
(none)
92
Enrollment
16
Locations
4
Arms
60.4
Anticipated Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Actual Study Start Date :
Mar 8, 2018
Anticipated Primary Completion Date :
Mar 19, 2023
Anticipated Study Completion Date :
Mar 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A Dose Escalation: BMS-986258

Biological: BMS-986258
Specified dose on specified days
Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)

Biological: BMS-986258
Specified dose on specified days

Drug: rHuPH20
Specified dose on specified days
Other Names:
  • Enhanze

    		•
    Experimental: Part B Dose Escalation: BMS-986258 + nivolumab

    Biological: BMS-986258
    Specified dose on specified days

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

    		•
    Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab

    Biological: BMS-986258
    Specified dose on specified days

    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 AEs leading to death [Approximately 2 years]

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

    Secondary Outcome Measures

    1. Objective response rate (ORR) [Up to 12 months]

    2. Median duration of response (mDOR) [Up to 12 months]

    3. Progression free survival (PFS) rate [Up to 12 months]

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

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

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

    7. Observed concentration at the end of a dosing interval (Ctau) [Approximately 2 years]

    8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [Approximately 2 years]

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

    10. Concentration at the end of infusion (Ceoi) [Approximately 2 years]

    11. Incidence of anti-drug antibody (ADA) to BMS-986258 [Approximately 2 years]

    Eligibility Criteria

    Criteria

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

    • Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)

    • Eastern Cooperative Oncology Group Performance Status of 0 or 1

    • Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies

    • Women must agree to follow specific methods of contraception, if applicable

    Exclusion Criteria:

    • Active, known or suspected autoimmune disease

    • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

    • Other active malignancy requiring concurrent intervention

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hoag Memorial Hospital Presbyterian Los Angeles California United States 90033
    2 Usc/Norris Comprehensive Cancer Center Los Angeles California United States 90033
    3 University Of Colorado Aurora Colorado United States 80045
    4 Local Institution New Haven Connecticut United States 06520
    5 Local Institution Iowa City Iowa United States 52242
    6 Local Institution Ann Arbor Michigan United States 48109-5912
    7 START Midwest Grand Rapids Michigan United States 49546
    8 University of Cincinnati Medical Center Cincinnati Ohio United States 45267
    9 University Of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    10 The West Clinic, P.C. Germantown Tennessee United States 38138
    11 Local Institution Westmead New South Wales Australia 2145
    12 Local Institution Heidelberg Victoria Australia 3084
    13 Local Institution Edmonton Alberta Canada T6X 1E8
    14 Local Institution Vancouver British Columbia Canada V5Z 4E6
    15 Local Institution Kobe-shi Hyogo Japan 6500017
    16 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:
    NCT03446040
    Other Study ID Numbers:
    • CA031-002
    • 2019-000442-35
    First Posted:
    Feb 26, 2018
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nivolumab

    Study Results

    No Results Posted as of Feb 14, 2022