A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors

Completed · Phase 1

Conditions studied: Advanced Cancer

In brief

The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.

Key facts

Study ID

NCT05298592

Run by

Bristol-Myers Squibb

People needed

77

Starts

2022-03-31

Expected to finish

2024-08-16

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parts 1A, 1B, 1C:
• Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
• Part 1D:
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.
• All Parts:
• Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Adequate organ function

You may not qualify if…

• Prior organ or tissue allograft
• Leptomeningeal metastases
• Untreated CNS metastases
• Serious or uncontrolled medical disorders
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0021 — Birmingham, Alabama, United States
• University California San Diego Moores Cancer Center — La Jolla, California, United States
• The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate — Los Angeles, California, United States
• UCLA Health — Los Angeles, California, United States
• Local Institution - 0001 — Hackensack, New Jersey, United States
• Carolina BioOncology Institute, PLLC — Huntersville, North Carolina, United States
• Sanford Cancer Center — Sioux Falls, South Dakota, United States
• Mary Crowley Cancer Research - Medical City Hospital — Dallas, Texas, United States
• Local Institution - 0006 — Richmond, Virginia, United States
• Local Institution - 0029 — Viedma, Río Negro Province, Argentina
• Local Institution - 0023 — Rosario, Santa Fe Province, Argentina
• Local Institution - 0028 — Buenos Aires, Argentina
• Local Institution - 0032 — Córdoba, Argentina
• Local Institution - 0018 — Jette, Brussels Capital, Belgium
• Local Institution - 0015 — Edegem, MA, Belgium
• Local Institution - 0012 — Brussels, Belgium
• Local Institution - 0031 — Kashiwa-shi, Chiba, Japan
• Local Institution - 0026 — Seongnam-si, Gyeonggi-do, South Korea
• Local Institution - 0024 — Seoul, South Korea
• Local Institution - 0027 — Seoul, South Korea
• Local Institution - 0025 — Seoul, South Korea
• Local Institution - 0008 — Málaga, Andaluca, Spain
• Local Institution - 0030 — Barcelona, Spain
• Local Institution - 0017 — Barcelona, Spain
• Institut Catala dOncologia ICO - Hospital Duran i Reynals Location — Barcelona, Spain

Full record on ClinicalTrials.gov

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