CC Gastric/GEJ Adenocarcinoma MSS-CRC NSCLC SCCHN RCC UC PAC Melanoma ONs TNBC
Conditions
Interventions
Drug: BMS-986340
Drug: Nivolumab
Drug: Docetaxe(Ex-Japan)
Sponsors
Oza Jay
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event, serious adverse event, dose-limiting toxicity, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK, Incidence of anti-drug antibodies, ORR, DCR, DOR, PFSR, etc. | — |
Countries
Australia, Canada, China, Germany, Israel, Italy, Japan, Spain, United States
Contacts
Public ContactJay Oza
Bristol-Myers Squibb
Outcome results
None listed