Actively Recruiting
Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma
Led by Myung-Ju Ahn · Updated on 2023-02-14
50
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed resectable, clinically node-positive high-grade salivary gland carcinoma
- No previous chemotherapy treatment for this cancer
- At least one measurable or non-measurable lesion per RECIST 1.1 confirmed by imaging within 28 days before treatment
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Laboratory test results within specified limits within 28 days before treatment, including white blood cells, neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, and kidney function
- Women of childbearing potential must agree to use contraception during and after treatment as specified
- Men must agree to use contraception during and after treatment as specified
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Prior systemic anti-cancer therapy within the past 5 years
- Previous antineoplastic treatments for high-grade salivary gland carcinoma before study treatment
- Prior radiotherapy
- Residual adverse effects from prior treatments affecting safety
- Current or history of autoimmune disease
- Symptomatic or treated brain or meningeal metastases
- Pericardial fluid, pleural effusion, or ascites requiring treatment
- Recent transient ischemic attack, stroke, or thrombosis within 180 days
- Uncontrollable or significant cardiovascular diseases
- Uncontrollable diabetes mellitus
- Systemic infections requiring treatment
- Recent use of systemic corticosteroids or immunosuppressants within 28 days
- Recent surgeries within specified time frames before enrollment
- Recent use of radiopharmaceuticals except for diagnostic purposes
- Pregnant or breastfeeding women
- Recent use of unapproved drugs within 28 days
- Inability to provide informed consent
- History of severe hypersensitivity to nivolumab or other antibody products
- History of pneumonitis requiring steroids or current pneumonitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710
Actively Recruiting
Research Team
M
Myung-Ju Ahn, Ph.D.
CONTACT
H
HyeJung Chae
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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