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

Launched by BRISTOL-MYERS SQUIBB · May 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BMS-986340 for patients with advanced solid tumors, which include various types of cancers like cervical cancer, lung cancer, and breast cancer. The main goal is to find out how safe the treatment is, how well it is tolerated by patients, and the best dose to use. Participants may receive BMS-986340 alone or in combination with other medications, such as nivolumab or docetaxel. This is the first time BMS-986340 is being tested in humans.

To join the study, participants typically need to be between the ages of 65 and 74, have measurable cancer that has worsened despite prior treatments, and provide a fresh tumor biopsy for testing. Those who are pregnant, have certain brain cancers, or have other significant health issues may not be eligible. If someone takes part in this trial, they can expect regular visits for monitoring and assessments as the study progresses. This trial is currently recruiting participants, and it is an important step in understanding how BMS-986340 can help patients with difficult-to-treat cancers.

Gender

ALL

Eligibility 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