Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 15, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
High-grade Salivary Gland Carcinoma
Interventions
DRUG

nivolumab, docetaxel, cisplatin Group

Patients will be treated with nivolumab 360mg and plus docetaxel 60mg/m2 and cisplatin 60mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive radiation 59.4 Gy in 27 fractions. Boost RT of 6.6 Gy in 3 fractions to tumor bed and/or gross tumor will be optional in patients who had R1-R2 resection. If tumors are regarded inoperable after neoadjuvant therapy (due to high risk of post-operative complication, or metastatic disease), they will be off from this study and receive the appropriate treatment, though they will be also included in the efficacy and safety analyses.

Trial Locations (1)

135-710

RECRUITING

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul

All Listed Sponsors
lead

Myung-Ju Ahn

OTHER