A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors
- Conditions
- Advanced Solid TumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000416-21-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
-Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy;
-Eastern Cooperative Oncology Group Performance Status of 0 or 1;
-Some participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies;
-Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some patients;
-Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation;
-Willing and able to comply with all study procedures.
Other protocol defined inclusion criteria could 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 338
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
-Participants with primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded;
-Active, known, or suspected autoimmune disease;
-Participants with other active malignancy requiring concurrent intervention;
-Prior organ allograft.
Other protocol defined exclusion criteria could apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method