eVOLVE-HNSCC
Research type
Research Study
Full title
A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
IRAS ID
1008593
Contact name
Ghada Chaabani
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are seeking a better way to treat specific type of cancer that affects the head and neck.
This cancer, called locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is caused
by cells in the head and neck growing out-of-control, has spread to glands (called lymph nodes) in the
neck and has not been removed by surgery. Currently, LA-HNSCC is treated with a combination of
chemotherapy and radiotherapy (cCRT). After cCRT treatment, the only option is to observe if the
cancer returns.
In order to participate in this trial, participants must have completed cCRT treatment. This trial aims
to assess a drug called volrustomig used after cCRT treatment. Volrustomig is designed to help the
immune system kill cancer cells. The trial is designed to understand if volrustomig is safe; if it will
improve the time it takes for the cancer to return and if the patients taking it live longer than the ones
who do not.
This is a phase 3, randomized, open-label trial, where participant receive treatment for up to 12
months. Randomized means that each participant’s treatment will be randomly assigned by a
computer program. Open-label means the participants, researchers, trial doctors, and other trial staff
will know what each participant is receiving.
This trial will include about 1145 participants with HNSCC.
Participants will be randomly assigned to one of 2 treatment groups:
1. Arm A – Volrustomig: on Day 1 of each 21-day cycle for up to 12 months or 18 cycles or
until RECIST 1.1 progression.
2. Arm B – Observation: undergo observation for up to 12 months or until RECIST 1.1
progression.
Volrustomig will be given through a needle put into a vein (IV infusion).
The treatment length of time for a patient will depend on their individual response to it.REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0138
Date of REC Opinion
19 Feb 2024
REC opinion
Further Information Favourable Opinion