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

A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Docetaxel; Drug: Nivolumab; Drug: BMS-986360; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aires, Argentina, 1426
    • Local Institution - 0031
  • Buenos Aires
    • Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
      • Local Institution - 0033
  • Ciudad Autónoma De Buenos Aires
    • Caba, Ciudad Autónoma De Buenos Aires, Argentina, C1430EGF
      • Local Institution - 0030
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Local Institution - 0010
    • St Leonards, New South Wales, Australia, 2065
      • Local Institution - 0061
  • Queensland
    • Brisbane, Queensland, Australia, 4120
      • Local Institution - 0008
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Local Institution - 0063
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution - 0003
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0005
• Chile
  • Región Metropolitana De Santiago
    • Santiago, Región Metropolitana De Santiago, Chile, 7500921
      • Local Institution - 0047
    • Santiago, Región Metropolitana De Santiago, Chile, 8330032
      • Local Institution - 0035
    • Santiago, Región Metropolitana De Santiago, Chile, 8420383
      • Local Institution - 0034
• France
  • Paris, France, 75248
    • Local Institution - 0048
  • Toulouse, France, 31059
    • Local Institution - 0050
  • Provence-Alpes-Côte-d'Azur
    • Marseille, Provence-Alpes-Côte-d'Azur, France, 13273
      • Local Institution - 0049
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94800
      • Local Institution - 0052
• Italy
  • Padova, Italy, 35128
    • Local Institution - 0065
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Local Institution - 0057
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Local Institution - 0059
• Mexico
  • Puebla, Mexico, 72424
    • Local Institution - 0037
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 03100
      • Local Institution - 0038
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45070
      • Local Institution - 0041
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Local Institution - 0039
• Spain
  • Sevilla, Spain, 41013
    • Local Institution - 0064
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08036
      • Local Institution - 0053
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28034
      • Local Institution - 0055
    • Madrid, Madrid, Comunidad De, Spain, 28041
      • Local Institution - 0056
• United States
  • California
    • Los Angeles, California, United States, 90025
      • Local Institution - 0029
    • Los Angeles, California, United States, 90067
      • Local Institution - 0051
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Local Institution - 0026
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0001
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Local Institution - 0018
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0028
  • Texas
    • San Antonio, Texas, United States, 78229
      • Local Institution - 0027
  • Utah
    • West Valley City, Utah, United States, 84119
      • Local Institution - 0046

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986360	Drug: BMS-986360; Specified dose on specified days; Other Names: CC-90001
Experimental: BMS-986360 + Docetaxel	Drug: Docetaxel; Specified dose on specified days; Other Names: Taxotere®; Drug: BMS-986360; Specified dose on specified days; Other Names: CC-90001
Experimental: BMS-986360 + Nivolumab	Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo®; Drug: BMS-986360; Specified dose on specified days; Other Names: CC-90001
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Events (AEs)	Up to approximately 2 years
Number of participants with Serious Adverse Events (SAEs)	Up to approximately 2 years
Number of participants with Dose-Limiting Toxicities (DLTs)	Up to approximately 2 years
Number of participants with AEs leading to discontinuation	Up to approximately 2 years
Number of deaths	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax)	Up to approximately 2 years
Area under the plasma concentration-time curve (AUC)	Up to approximately 2 years
Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator	Up to approximately 2 years
Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment	Up to approximately 2 years
Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator	Up to approximately 2 years
Part 2: DOR based on RECIST v1.1 by BICR assessment	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Nivolumab; Solid tumors; Chemotherapy; CC-90001; BMS-986360
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine; Nivolumab
• Other Study ID Numbers: IM043-004; 2022-500930-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No