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An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03994601
Collaborator
(none)
344
Enrollment
27
Locations
2
Arms
55.2
Anticipated Duration (Months)
12.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
344 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-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Actual Study Start Date :
Sep 6, 2019
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Apr 13, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A BMS-986288

Drug: BMS-986288
Specified dose on specified days
Experimental: Arm B BMS-986288 in combination with Nivolumab

Drug: BMS-986288
Specified dose on specified days

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Up to 2 years]

    2. Incidence of Serious Adverse Events (SAEs) [Up to 2 years]

    3. Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria [Up to 2 years]

    4. Incidence of AEs leading to discontinuation [Up to 2 years]

    5. Incidence of AEs leading to death [Up to 2 years]

    6. Incidence of AEs leading to laboratory abnormalities [Up to 2 years]

    Secondary Outcome Measures

    1. Maximum Observed Concentration (Cmax) of BMS-986288 [Up to 2 years]

    2. Time of Maximum Observed Concentration (Tmax) of BMS-986288 [Up to 2 years]

    3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 [Up to 2 years]

    4. Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 [Up to 2 years]

    5. Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 [Up to 2 years]

    6. Trough Observed Concentrations (Ctrough) of BMS-986288 [Up to 2 years]

    7. Total Body Clearance (CLT) of BMS-986288 [Up to 4 months]

    8. Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 [Up to 4 months]

    9. Accumulation Index (AI) of BMS-986288 [Up to 4 months]

    10. Terminal Half-Life (T-HALF) of BMS-986288 [Up to 4 months]

    11. Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 [Up to 2 years]

    12. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment [Up to 4 years]

    13. Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment [Up to 4 years]

    14. Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment [Up to 4 years]

    15. Time to Response (TTR) by RECIST v1.1 by Investigator Assessment [Up to 4 years]

    16. Percentage of change from baseline in T-regulatory cells (Tregs) [Up to 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 or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy

    • Eastern Cooperative Oncology Group Performance Status of 0 or 1

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

    Exclusion Criteria:

    • Active, known or suspected autoimmune disease

    • Active malignancy requiring concurrent intervention

    • Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Colorado Aurora Colorado United States 80045
    2 Johns Hopkins University Baltimore Maryland United States 21287
    3 Washington University Saint Louis Missouri United States 63110
    4 Hackensack University Medical Center Hackensack New Jersey United States 07601
    5 Local Institution - 0011 Ciudad Autónoma De Buenos Aires Buenos Aires Argentina 1426
    6 Local Institution - 0014 Córdoba Cordoba Argentina X5000HXL
    7 Local Institution - 0013 Río Cuarto Cordoba Argentina 5800
    8 Local Institution ABB Distrito Federal Argentina C1199
    9 Local Institution Buenos Aires Distrito Federal Argentina 1431
    10 Local Institution - 0012 Caba Distrito Federal Argentina C1430
    11 Local Institution - 0016 Buenos Aires Argentina C1280AEB
    12 Local Institution - 0006 Toronto Ontario Canada M5G 1X6
    13 Local Institution - 0019 Santiago Metropolitana Chile 7510032
    14 Local Institution - 0009 Santiago Metropolitana Chile 8420383
    15 Local Institution - 0010 Viña del Mar Valparaiso Chile 2520598
    16 Local Institution - 0018 Bron Cedex France 69677
    17 Local Institution - 0026 Marseille France 13915
    18 Local Institution Paris France 75005
    19 Local Institution - 0021 Toulon France 83100
    20 Local Institution Ancona Italy 60126
    21 Local Institution Catanzaro Italy 88100
    22 Local Institution Milano Italy 20162
    23 Local Institution Milano Italy 20162
    24 Local Institution Monza Italy 20900
    25 Local Institution - 0023 Madrid Spain 28041
    26 Local Institution - 0024 Majadahonda Spain 28222
    27 Local Institution - 0025 València Spain 46026

    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:
    NCT03994601
    Other Study ID Numbers:
    • CA043-001
    First Posted:
    Jun 21, 2019
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 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 Jul 13, 2022