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

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT04895709

This study is testing a new treatment called BMS-986340, both on its own and with other drugs, to see how safe it is for people with advanced solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment949 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsnivolumab
Locations48 sites (Clovis, California and 47 other locations)
Trial IDNCT04895709 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors who have progressed on standard therapies and can provide tumor biopsies.

Not a fit: Patients who have not received prior therapies or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer new treatment options for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, 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 this trial is running

Clovis, California and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.