NANORAY-312
Research type
Research Study
Full title
A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma
IRAS ID
302425
Contact name
Claire Paterson
Contact email
Sponsor organisation
Nanobiotix SA
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
136067, IND; CIV-21-10-037887, CIV-ID; jRCT2051220124 , Japan Registry of Clinical Trials
Duration of Study in the UK
3 years, 5 months, 9 days
Research summary
The purpose of this research study is to evaluate safety/effectiveness of NBTXR3 injected directly into tumour and used together with radiotherapy alone or radiotherapy combined with cetuximab, and how it compares with radiotherapy alone, or radiotherapy combined with cetuximab in patients suffering from head and neck squamous cell cancer. The study is expected to enrol around 500 participants and Nanobiotix SA is the Sponsor.
This study is split up into three different periods: Screening, Treatment, and Follow-up Period. The screening and treatment period will last around 13 weeks. The follow-up period will be until death, lost to follow-up, withdrawal of consent, or end of study (expected 48 months after first randomised patient), whichever occurs first.
Treatment Period: Participants in Arm A (with NBTXR3)- NBTXR3 will be administered around Day 5 after randomisation. Participants will be observed for 2 hrs. They will return to the clinic at least 24 hrs after the injection in order to evaluate how the injected product is located within the tumour.
If receiving cetuximab, this will be given around 1 week before the start of radiotherapy. Premedication for subsequent administrations should be based upon clinical judgment and prior infusion reactions.
Radiotherapy will start between Day 10 and Day 19 after randomisation.
Participants will have a daily radiotherapy treatments (up to 20 mins) with a rest on the weekends. Consecutive doses of cetuximab (if applicable) will be given during radiotherapy, once per week.
Participants in Arm B (without NBTXR3)- If receiving cetuximab, this will be given around 1 week before the start of radiotherapy.
Radiotherapy will start between Day 10 and Day 19 after randomisation.
Participants will have a daily radiotherapy treatments (up to 20 mins) with a rest on the weekends. Consecutive doses of cetuximab (if applicable) will be given during radiotherapy, once per week.
A Global EoT and Follow-up period.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0088
Date of REC Opinion
10 Jun 2022
REC opinion
Further Information Favourable Opinion