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A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02913313
Collaborator
Ono Pharmaceutical Co. Ltd (Industry)
241
Enrollment
20
Locations
6
Arms
98.6
Anticipated Duration (Months)
12.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
241 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Actual Study Start Date :
Nov 30, 2016
Anticipated Primary Completion Date :
Mar 19, 2024
Anticipated Study Completion Date :
Feb 18, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1A: Dose Escalation Monotherapy

Drug: BMS-986207
Specified dose on specified days
Experimental: Part 1B: Dose Escalation Combination Therapy

Drug: BMS-986207
Specified dose on specified days

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

    		•
    Experimental: Part 2A: Expansion Monotherapy

    Drug: BMS-986207
    Specified dose on specified days
    Experimental: Part 2B: Expansion Combination Therapy

    Drug: BMS-986207
    Specified dose on specified days

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

    		•
    Experimental: Part 1C: Triplet Cohort

    Drug: BMS-986207
    Specified dose on specified days

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

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

    		•
    Experimental: Part 2C: Triplet Expansion

    Drug: BMS-986207
    Specified dose on specified days

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Up to 27 months]

    2. Incidence of Serious Adverse Events (SAEs) [Up to 27 months]

    3. Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [Up to 6 weeks]

    4. Incidence of AEs leading to discontinuation [Up to 27 months]

    5. Incidence of deaths [Up to 27 months]

    6. Number of participants with laboratory abnormalities [Up to 27 months]

    7. Objective response rate (ORR) [Up to 36 months]

    8. Median duration of response (mDOR) [Up to 36 months]

    9. Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [At 24 weeks]

    Secondary Outcome Measures

    1. Objective response rate (ORR) [Up to 36 months]

    2. Median duration of response (mDOR) [Up to 36 months]

    3. Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 [At 24 Weeks]

    4. Maximum observed serum concentration (Cmax) [Up to 27 months]

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

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

    7. Incidence of anti-drug antibody (ADA) [Up to 27 months]

    Eligibility Criteria

    Criteria

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

    • Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment

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

    • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization

    Exclusion Criteria:

    • Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll

    • Other active malignancy requiring concurrent intervention

    • Uncontrolled or significant cardiovascular disease

    • Active, known, or suspected autoimmune disease

    • NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    2 Columbia University Medical Center (Cumc) New York New York United States 10032
    3 Local Institution - 0012 Philadelphia Pennsylvania United States 19104
    4 Local Institution - 0002 Philadelphia Pennsylvania United States 19111
    5 UPMC Cancer Center Pittsburgh Pennsylvania United States 15213
    6 Local Institution - 0010 Salt Lake City Utah United States 84112
    7 Local Institution - 0019 Córdoba Cordoba Argentina X5002HWE
    8 Local Institution - 0022 Buenos Aires Distrito Federal Argentina C1093AAS
    9 Local Institution - 0023 Caba Distrito Federal Argentina C1430
    10 Local Institution - 0006 Nedlands Western Australia Australia 6009
    11 Local Institution - 0008 Ottawa Ontario Canada K1H 8L6
    12 Local Institution - 0007 Toronto Ontario Canada M5G 2M9
    13 Local Institution - 0021 Santiago Metropolitana Chile 8420383
    14 Local Institution - 0004 Kashiwa-shi Chiba Japan 2778577
    15 Local Institution - 0005 Chuo-ku Tokyo Japan 1040045
    16 Local Institution Bucharest Romania 022328
    17 Local Institution Cluj-Napoca Romania 400015
    18 Local Institution Craiova Romania 200347
    19 Local Institution Floresti/ Cluj Romania 407280
    20 Local Institution Singapore Singapore 119074

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • 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:
    NCT02913313
    Other Study ID Numbers:
    • CA020-002
    • 2016-002263-34
    First Posted:
    Sep 23, 2016
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 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
    First line NSCLC
    Additional relevant MeSH terms:
    Neoplasms
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Jul 28, 2022