TG4050.02 clinical trial (protocol v2.0)
Research type
Research Study
Full title
A randomized phase I trial in patients with newly-diagnosed, locoregionally advanced, HPV-negative, squamous cell carcinoma of the head and neck (SCCHN) evaluating a mutanome-directed immunotherapy initiated at completion of primary treatment or at time of recurrence.
IRAS ID
264885
Contact name
Christian Ottensmeier
Contact email
Sponsor organisation
TRANSGENE
Eudract number
2018-003267-58
Duration of Study in the UK
3 years, 10 months, 0 days
Research summary
TG4050 is an investigational medicinal product manufactured specifically for each patient based on identification of tumour specific mutations. Tumour specific mutations expressed in the tumour tissue are detected by comparing the tumour and healthy tissue. In the following, mutated sequences are used to design a synthetic gene which is then cloned in a modified vaccinia Ankara viral vector. When administered to the patient TG4050 aims training the immune system to recognize the abnormal proteins coded by the mutated genes as foreign and then to destroy cancer cells that bear any of these proteins.
In the TG4050.02 clinical trial the safety and activity of TG4050 are evaluated in patients with newly-diagnosed, locoregionally advanced, HPV-negative, squamous cell carcinoma of the head and neck (SCCHN).
TG4050.02 consists of two distinct parts:
• A screening phase starting at or just before surgery when patients’ samples (blood and tumour) are collected to manufacture a TG4050 individualized product. During this phase, the patients receive their primary treatment (chemotherapy and/or radiotherapy) per usual medical practice.
• A treatment phase when patients receive TG4050 treatment. Patients in Arm A will receive TG4050 upon completion of primary treatment and radiological documentation of complete response. Patients in Arm B will receive TG4050 at the time of recurrence in combination with standard of care. Patient will receive TG4050 injections as long as not showing progressive disease and treatment is well tolerated for a maximum of 20 administrations. Arm A patients will receive a second round of TG4050 injections at the time of relapse if the first round has been well tolerated.Thirty patients will be enrolled in France and UK. In UK, patients will be enrolled in clinical centers located in Liverpool, London and Southampton.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0500
Date of REC Opinion
26 Mar 2020
REC opinion
Further Information Favourable Opinion