Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Phase 1

Active, not recruiting

• Conditions: eoplasms by site; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10067821Term: Head and neck cancer Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10067946Term: Renal cell carcinoma Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10017758Term: Gastric cancer Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10053571Term: Melanoma Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10005003Term: Bladder cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508067-70-00
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified