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

NCT05727410 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-02-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Myung-Ju Ahn

    lead OTHER

Principal Investigators

  • Myung-Ju Ahn, Ph.D. · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727410 on ClinicalTrials.gov