High-grade Salivary Gland Carcinoma Clinical Trial
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
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
This is a phase II, single center, open-label, single arm study in patients with resectable, high grade salivary gland carcinoma. 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00095563 -
Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
|
Phase 2 |