Testing BMS-986340 alone and with other treatments for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of BMS-986340, both as a standalone treatment and in combination with nivolumab or docetaxel, in patients with advanced solid tumors. It is a first-in-human trial that aims to determine the recommended doses for these therapies. Participants must provide tumor biopsies for biomarker analysis and have measurable disease that has progressed after standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Radiographically documented progressive disease on or after the most recent therapy.
* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.

Exclusion Criteria

* Women who are pregnant or breastfeeding.
* Primary central nervous system (CNS) malignancy.
* Untreated CNS metastases.
* Leptomeningeal metastases.
* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
* Active, known, or suspected autoimmune disease.
* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
* Prior organ or tissue allograft.
* Uncontrolled or significant cardiovascular disease.
* Major surgery within 4 weeks of study drug administration.
* History of or with active interstitial lung disease or pulmonary fibrosis.
* Other protocol-defined inclusion/exclusion criteria apply.

Where it's running

• Community Cancer Institute
  Clovis, California, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• John Theurer Cancer Center
  Hackensack, New Jersey, United States Recruiting
• Providence Cancer Center Oncology and Hematology Care- Eastside
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.