CA052002 is a Phase 1/2, multi-center, open-label study of BMS-986340 administered as a single agent and in combination with nivolumab in participants with select advanced solid tumors
- Conditions
- Male and female participants = 18 years of age with advanced or metastatic cancers .Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001188-26-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 105
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety, tolerability, and to determine the MTD, MAD, and/or RP2D(s) of BMS-986340 administered as monotherapy and in combination with nivolumab;Secondary Objective: - To characterize the PK profile of BMS-986340 administered as monotherapy and in combination with nivolumab<br>- To characterize the immunogenicity of BMS-986340 administered as monotherapy and in combination with nivolumab<br>- To assess the preliminary anti-tumor activity of BMS-986340 as monotherapy and in combination with nivolumab;Primary end point(s): Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities;Timepoint(s) of evaluation of this end point: continuously
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab<br>2) Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab<br>3) ORR, DCR, DOR, and PFSR;Timepoint(s) of evaluation of this end point: 1) depends on the cycles<br>2) continuously<br>3) at 6 months and 1 year per RECIST v1.1 by investigator