An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab or Nivolumab plus Ipilimumab in Patients with Advanced Cancers
- Conditions
- Advanced solid tumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509061-20-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 639
At least 1 lesion accessible for biopsy, Eastern Cooperative Oncology Group Performance Status of 0 or 1, Non-small cell lung carcinoma (only Part 1A and Part 1 Cohorts 1B1 through 1B5 [enrolled through revised Protocol 03]. Participants with NSCLC will not be allowed in Parts 1B6, 1B7 and 1C as per protocol Amendment 04).
Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll), Participants with active, known or suspected autoimmune disease, Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration, Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS), Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
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