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

• Status: Recruiting
• Trial end date: 2026-08-31

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

• Phase: Phase 2

Details

• Lead Sponsor: Myung-Ju Ahn
• Treatments: Cisplatin; Docetaxel; Nivolumab