Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma

Phase 1 Completed 12 enrolled NYU Langone Health Bristol-Myers Squibb · collab Daiichi Sankyo · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety profile, tolerability, and immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with nivolumab (anti-PD-1 antibody) to subjects with unresectable Stage III or Stage IV melanoma.

Timeline

Start: 2016-10
Primary completion: 2019-12-23
Completion: 2021-01-01

Publications

Yoshida T, Ichikawa J, Giuroiu I, Laino AS, Hao Y, Krogsgaard M, Vassallo M, Woods DM, Stephen Hodi F, Weber J. C reactive protein impairs adaptive immunity in immune cells of patients with melanoma. J Immunother Cancer. 2020 Apr;8(1):e000234. doi: 10.1136/jitc-2019-000234.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DS-8273a	Monoclonal antibody	2 mg/kg	Intravenous
Subject	DS-8273a	Monoclonal antibody	4 mg/kg	Intravenous
Subject	DS-8273a	Monoclonal antibody	8 mg/kg	Intravenous
Subject	DS-8273a	Monoclonal antibody	16 mg/kg	Intravenous
Subject	DS-8273a	Monoclonal antibody	24 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	5 mg/kg	Intravenous

Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma

Summary

Timeline

Publications

Drugs

Indications