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A Phase I / 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

Status
Active
Cancer Type
Bladder Cancer
Cervical Cancer
Kidney Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Skin Cancer (Non-Melanoma)
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT01968109
Protocol IDs
CA224-020 (primary)
NCI-2014-00315
2014-002605-38
Study Sponsor
Bristol-Myers Squibb

Summary

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and / or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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