A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05625412
Collaborator
(none)
220
16
4
55.7
13.8
0.2

Study Details

Study Description

Brief Summary

The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Actual Study Start Date :
Dec 9, 2022
Anticipated Primary Completion Date :
May 1, 2026
Anticipated Study Completion Date :
Jul 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986360

Drug: BMS-986360
Specified dose on specified days
Other Names:
  • CC-90001
  • Experimental: BMS-986360 + Docetaxel

    Drug: BMS-986360
    Specified dose on specified days
    Other Names:
  • CC-90001
  • Drug: Docetaxel
    Specified dose on specified days
    Other Names:
  • Taxotere®
  • Experimental: BMS-986360 + Nivolumab

    Drug: BMS-986360
    Specified dose on specified days
    Other Names:
  • CC-90001
  • Drug: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo®
  • BMS-936558
  • Experimental: BMS-986360 + Capecitabine

    Drug: BMS-986360
    Specified dose on specified days
    Other Names:
  • CC-90001
  • Drug: Capecitabine
    Specified dose on specified days
    Other Names:
  • Xeloda®
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Adverse Events (AEs) [Up to approximately 2 years]

    2. Number of participants with Serious Adverse Events (SAEs) [Up to approximately 2 years]

    3. Number of participants with Dose-Limiting Toxicities (DLTs) [Up to approximately 2 years]

    4. Number of participants with AEs leading to discontinuation [Up to approximately 2 years]

    5. Number of deaths [Up to approximately 2 years]

    Secondary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to approximately 2 years]

    2. Time of maximum observed plasma concentration (Tmax) [Up to approximately 2 years]

    3. Area under the plasma concentration-time curve (AUC) [Up to approximately 2 years]

    4. Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator [Up to approximately 2 years]

    5. Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment [Up to approximately 2 years]

    6. Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator [Up to approximately 2 years]

    7. Part 2: DOR based on RECIST v1.1 by BICR assessment [Up to 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:
    • Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.

    • In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study.

    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

    • Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy)

    Exclusion Criteria:
    • Participants with primary central nervous system (CNS) disease, or tumors with CNS metastases as the only disease site, will be excluded. Participants with controlled brain metastases, however, will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), no longer taking steroids for at least 2 weeks prior to first dose of study intervention, and with no new or progressive neurological signs and symptoms.

    • Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.

    • Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease.

    • Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy

    Other protocol-defined inclusion/exclusion criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles California United States 90025
    2 Cedars-Sinai Medical Center Los Angeles California United States 90048
    3 Valkyrie Clinical Trials Los Angeles California United States 90067
    4 Ochsner Medical Center - Jefferson Highway New Orleans Louisiana United States 70121
    5 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    6 Carolina BioOncology Institute Huntersville North Carolina United States 28078
    7 Tennessee Oncology Nashville Nashville Tennessee United States 37203
    8 South Texas Accelerated Research Therapeutics (START) San Antonio Texas United States 78229
    9 START Mountain Region West Valley City Utah United States 84119
    10 NEXT Virginia Fairfax Virginia United States 22031
    11 Local Institution - 0032 ABB Ciudad Autónoma De Buenos Aires Argentina C1199ABB
    12 Local Institution - 0010 Darlinghurst New South Wales Australia 2010
    13 Local Institution - 0008 Brisbane Queensland Australia 4120
    14 Local Institution - 0003 Ottawa Ontario Canada K1H 8L6
    15 Local Institution - 0005 Toronto Ontario Canada M5G 2M9
    16 Local Institution - 0047 Santiago Región Metropolitana De Santiago Chile 6900941

    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:
    NCT05625412
    Other Study ID Numbers:
    • IM043-004
    • 2022-500930-27
    First Posted:
    Nov 22, 2022
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2023