NCT03838263

Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer

A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer

Detailed description

Methodology: Patient screened wil be randomized 2:1 between 2 arms: * Experimental arm: Nivolumab 2 infusions (2 weeks part) before standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7 * Control arm: Standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7 Primary Objective: To assess the feasibility and tolerance of neoadjuvant nivolumab treatment before chemoradiation in "high-risk" HPV-driven Oropharynx Cancer

Conditions

• Oropharynx Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.
RADIATION	Chemoradiation	Standard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7

Timeline

• Start date: 2019-07-25
• Primary completion: 2022-04-01
• Completion: 2024-11-20
• First posted: 2019-02-12
• Last updated: 2025-03-04

Locations

11 sites across 1 country: France