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NCT05727410

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

Recruiting now Phase 2 Last updated 14 February 2023
What this trial tests

Phase 2 trial testing nivolumab, docetaxel, cisplatin Group in High-grade Salivary Gland Carcinoma in 50 participants. Currently enrolling.

Timeline
15 November 2022
Primary endpoint
31 August 2026
31 August 2026

Quick facts

Lead sponsorMyung-Ju Ahn
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date15 November 2022
Primary completion31 August 2026
Estimated completion31 August 2026
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Myung-Ju Ahn — full company profile →

Who can join

19 and older, any sex, with High-grade Salivary Gland Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05727410.

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