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RECRUITING
NCT05727410
PHASE2

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

Sponsor: Myung-Ju Ahn

View on ClinicalTrials.gov

Summary

1. Primary Objective: \- Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor 2. Secondary Objectives: * Complete resection rate * Response rate to neoadjuvant therapy according to RECIST 1.1 * Downstaging at pathologic staging compared to clinical staging performed at study entry * Distant metastasis free survival (DMFS) rate at 2 years * Disease free survival at 2 years * Overall survival rate at 2 years * Safety and feasibility 3. Exploratory Objectives: * PD L1 expression by 28-8 immunohistochemistry * IHC (HER2, AR, etc) * Whole exome sequencing (WES) * Whole transcriptome sequencing (WTS) * Peripheral blood biomarkers (CD4+ T cells, CD8+ T cell, myeloid derived suppressor cells (MDSC), Treg etc) * Interferon gamma related gene expression profile * Multiplex florescence measure of tumor cells and tumor microenvironment cells

Official title: A Phase II Trial of Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-11-15

Completion Date

2026-08-31

Last Updated

2023-02-14

Healthy Volunteers

No

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.

Locations (1)

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

Seoul, South Korea