drugset

drugset / Trial / NCT02946671

Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

NCT02946671 ↗

Phase 1 Completed 16 enrolled Osaka University Clinical Study Support, Inc. · collab Fiverings Co., Ltd. · collab Kyowa Kirin, Inc. · collab Ono Pharmaceutical Co., Ltd. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1). To assess the behavior of immune cells in peripheral blood and tumor.

Timeline

Start: 2016-03
Primary completion: 2020-03
Completion: 2020-03

Publications

Jinushi K, Saito T, Kurose K, Suzuki S, Kojima T, Takahara T, Makino T, Ogawa T, Nishikawa H, Kakimi K, Iida S, Nakajima J, Doki Y, Oka M, Ueda R, Wada H. Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors. J Immunother Cancer. 2025 Apr 2;13(4):e010634. doi: 10.1136/jitc-2024-010634.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mogamulizumab	Monoclonal antibody	0.1 mg/kg	—
Subject	Mogamulizumab	Monoclonal antibody	0.3 mg/kg	—
Subject	Mogamulizumab	Monoclonal antibody	1 mg/kg	—
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous

Indications