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

NCT05625412 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM043-0042022-500930-27
• Study Type: interventional
• Target: 70
• Locations: 9 countries
• Sites: 35

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.

Conditions

Advanced Solid Tumors

Keywords

Solid tumors; Nivolumab; Chemotherapy; BMS-986360; CC-90001

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (4)

BMS-986360

EXPERIMENTAL

Drug: BMS-986360

BMS-986360 + Docetaxel

EXPERIMENTAL

Drug: BMS-986360; Drug: Docetaxel

BMS-986360 + Nivolumab

EXPERIMENTAL

Drug: BMS-986360; Drug: Nivolumab

BMS-986360 + Capecitabine

EXPERIMENTAL

Drug: BMS-986360; Drug: Capecitabine

Interventions

BMS-986360 DRUG

Specified dose on specified days

Also known as: CC-90001

BMS-986360; BMS-986360 + Capecitabine; BMS-986360 + Docetaxel; BMS-986360 + Nivolumab

Docetaxel DRUG

Specified dose on specified days

Also known as: Taxotere®

BMS-986360 + Docetaxel

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo®, BMS-936558

BMS-986360 + Nivolumab

Capecitabine DRUG

Specified dose on specified days

Also known as: Xeloda®

BMS-986360 + Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (35)

Local Institution - 0029

Los Angeles, California, 90025, United States

Location

Local Institution - 0051

Los Angeles, California, 90067, United States

Location

Local Institution - 0026

New Orleans, Louisiana, 70121, United States

Location

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0018

Huntersville, North Carolina, 28078, United States

Location

Local Institution - 0028

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0027

San Antonio, Texas, 78229, United States

Location

Local Institution - 0046

West Valley City, Utah, 84119, United States

Location

Local Institution - 0033

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

Location

Local Institution - 0030

CABA, Buenos Aires F.D., C1430EGF, Argentina

Location

Local Institution - 0031

Buenos Aires, 1426, Argentina

Location

Local Institution - 0010

Darlinghurst, New South Wales, 2010, Australia

Location

Local Institution - 0061

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0008

Brisbane, Queensland, 4120, Australia

Location

Local Institution - 0063

Frankston, Victoria, 3199, Australia

Location

Local Institution - 0003

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0005

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0047

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0035

Santiago, Santiago Metropolitan, 8330032, Chile

Location

Local Institution - 0034

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0049

Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

Location

Local Institution - 0052

Villejuif, Val-de-Marne, 94800, France

Location

Local Institution - 0048

Paris, 75248, France

Location

Local Institution - 0050

Toulouse, 31059, France

Location

Local Institution - 0057

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0059

Candiolo, Torino, 10060, Italy

Location

Local Institution - 0065

Padua, 35128, Italy

Location

Local Institution - 0041

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0038

Mexico City, Mexico City, 03100, Mexico

Location

Local Institution - 0039

Monterrey, Nuevo León, 66460, Mexico

Location

Local Institution - 0037

Puebla City, 72424, Mexico

Location

Local Institution - 0053

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Local Institution - 0055

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Local Institution - 0056

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Local Institution - 0064

Seville, 41013, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

CC-90001; Docetaxel; Nivolumab; Capecitabine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 22, 2022
• Study Start: December 9, 2022
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); ES (4); IT (3); US (8); AR (3); ME (4); AU (4); CA (2); CL (3)