CTIS2023-508067-70-00Active, not recruitingPhase 1
A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors - CA224-020
Bristol Myers Squibb International Corporation0 sites2,000 target enrollmentStarted: January 17, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 2,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 0 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •For Dose escalation: subjects with cervical, ovarian, bladder and CRC, head and neck, gastric and hepatocellular cancer naive to immunooncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4., For Dose Expansion: all of the above in escalation except for cervical, ovarian and CRC, Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts., ECOG performance status of 0 to 2, At least 1 lesion with measurable disease at baseline, Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Exclusion Criteria
- •Primary CNS tumors or solid tumors with CNS metastases as the only site of active disease, Autoimmune disease, Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent, Uncontrolled CNS metastases
Investigators
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