EUCTR2021-001188-26-ESActive, not recruitingPhase 1
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab in Participants with Advanced Solid Tumors
Bristol-Myers Squibb International Corporation0 sites105 target enrollmentStarted: November 19, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 105
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
- •Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, 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
- •Other protocol-defined inclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
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 exclusion criteria apply
Investigators
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