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A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03251924
Collaborator
(none)
78
Enrollment
13
Locations
3
Arms
51.6
Actual Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Condition or Disease Intervention/Treatment Phase
  • Drug: BMS-986226
  • Biological: Nivolumab
  • Biological: Ipilimumab
  • Biological: Tetanus Vaccine
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Dec 20, 2021
Actual Study Completion Date :
Dec 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986226

administered intravenously

Drug: BMS-986226
specified dose on specified days

Biological: Tetanus Vaccine
specified dose on specified days
Experimental: BMS-986226 and Nivolumab

administered intravenously

Drug: BMS-986226
specified dose on specified days

Biological: Nivolumab
specified dose on specified days
Other Names:
  • BMS-936558
  • PD-1 receptor blocking monoclonal antibody [mAb]
  • Opdivo

    • Biological: Tetanus Vaccine
    specified dose on specified days
    Experimental: BMS-986226 and Ipilimumab

    administered intravenously

    Drug: BMS-986226
    specified dose on specified days

    Biological: Ipilimumab
    specified dose on specified days
    Other Names:
  • BMS-734016
  • MDX010
  • Checkpoint blocking antibody that recognizes CTLA-4
  • Yervoy

    • Biological: Tetanus Vaccine
    specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

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

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

    3. Incidence of AE due to discontinuation [Approximately 2 years]

    4. Incidence of AE resulting in death [Approximately 2 years]

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

    6. Incidence of clinical laboratory test abnormalities graded according to common terminology criteria for adverse events (CTCAE) [Approximately 2 years]

    Secondary Outcome Measures

    1. Objective response rate (ORR) measure by Clopper-Pearson method [Approximately 2 years]

    2. Median Duration of Response (mDOR) measured by Kaplan-Meier method [Approximately 2 years]

    3. Progression Free Survival (PFS) measured by Kaplan-Meier method [At 24 weeks]

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

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

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

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

    8. Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay [Approximately 2 years]

    9. Change from baseline in immunoassay for BMS-986226 [Approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 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:

    • Advanced solid tumors

    • Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).

    • At least 1 lesion accessible for biopsy in addition to the target lesion

    • Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen

    • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

    Exclusion Criteria:

    • Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll)

    • Participants with carcinomatous meningitis

    • Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

    • Active, known, or suspected autoimmune disease

    • Uncontrolled or significant cardiovascular disease

    • Participants with known allergies to egg products, neomycin and tetanus toxoid.

    • Prior adverse reaction to tetanus toxoid- containing vaccines.

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    2 Washington University School OF Medicine-Siteman Cancer Center Saint Louis Missouri United States 63110
    3 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    4 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    5 Tennessee Oncology, PLLC - SCRI - PPDS Nashville Tennessee United States 37203
    6 Local Institution Edmonton Alberta Canada T6G 1Z2
    7 Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    8 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 1Z5
    9 Local Institution Madrid Spain 28040
    10 Local Institution Madrid Spain 28050
    11 Kantonsspital Graubuenden Chur Switzerland 7000
    12 Chu Vaudois Lausanne Lausanne Switzerland 1011
    13 University Hospital Zuerich Zuerich Switzerland 8091

    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:
    NCT03251924
    Other Study ID Numbers:
    • CA021-002
    • 2017-000238-73
    First Posted:
    Aug 16, 2017
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Nivolumab
    Ipilimumab
    Antibodies
    Immunoglobulins
    Antibodies, Blocking

    Study Results

    No Results Posted as of Mar 25, 2022