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A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05407675
Collaborator
(none)
113
Enrollment
4
Locations
3
Arms
55.8
Anticipated Duration (Months)
28.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
113 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Actual Study Start Date :
Aug 2, 2022
Anticipated Primary Completion Date :
Mar 26, 2027
Anticipated Study Completion Date :
Mar 26, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: BMS-986408 Monotherapy

Drug: BMS-986408
Specified dose on specified days
Experimental: Part 2: BMS-986408 in combination with nivolumab

Drug: BMS-986408
Specified dose on specified days

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

    		•
    Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab

    Drug: BMS-986408
    Specified dose on specified days

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

    • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy
  • BMS-734016

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Dose-Limiting Toxicities (DLTs) [Up to 28 days]

    2. Number of participants with Adverse Events (AEs) [Up to 29 months]

    3. Number of deaths [Up to 50 months]

    Secondary Outcome Measures

    1. Maximum concentration (Cmax) [Up to 27 months]

    2. Time of maximum observed concentration (Tmax) [Up to 27 months]

    3. Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T)) [Up to 27 months]

    4. Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Up to 50 months]

    5. Duration of Response (DOR) assessed by RECIST v1.1 [Up to 50 months]

    Eligibility Criteria

    Criteria

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

    • Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    • Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant

    • Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)

    • Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

    Exclusion Criteria:

    • An active, known or suspected autoimmune disease

    • Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment

    • Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug

    • Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    2 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    3 Local Institution Houston Texas United States 77030
    4 Local Institution - 0007 Edmonton Alberta Canada T6G 1Z2

    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:
    NCT05407675
    Other Study ID Numbers:
    • CA099-003
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Cancer
    Oncology
    Phase 1
    Solid Tumor
    Additional relevant MeSH terms:
    Neoplasms
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Aug 25, 2022