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Completed

NCT Number: NCT05625412

A 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0033, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986360

Drug

Specified dose on specified days

Other names: CC-90001

docetaxel

Drug

Specified dose on specified days

Other names: Taxotere®

Nivolumab

Drug

Specified dose on specified days

Other names: Opdivo®, BMS-936558

Capecitabine

Drug

Specified dose on specified days

Other names: Xeloda®

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to approximately 2 years

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to approximately 2 years

  3. Number of participants with Dose-Limiting Toxicities (DLTs)

    Time frame: Up to approximately 2 years

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2 years

  5. Number of deaths

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to approximately 2 years

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to approximately 2 years

  3. Area under the plasma concentration-time curve (AUC)

    Time frame: 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

    Time frame: Up to approximately 2 years

  5. Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment

    Time frame: Up to approximately 2 years

  6. Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator

    Time frame: Up to approximately 2 years

  7. Part 2: DOR based on RECIST v1.1 by BICR assessment

    Time frame: Up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2022
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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