Clinical study TG4001.12 (V6.1)
Research type
Research Study
Full title
A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies including oropharyngeal squamous cell carcinoma of the head and neck (SCCHN)
IRAS ID
264220
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Transgene
Eudract number
2016-002799-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
TG4001 is a HPV-targeted immunotherapeutic virus and able to provide histologic clearance of cervical precancerous lesions. Avelumab is a human anti–PD-L1 monoclonal antibody. The combination of both is investigated in a phase Ib/II trial for the treatment of metastatic or recurrent HPV-16 positive cancers including oropharyngeal squamous cell carcinoma of the head and neck (SCCHN), cervical, vulvar, vaginal, penile and anal cancer. TG4001 and avelumab both being immunotherapy agents are expected to boost the immune system to fight the cancer and may provide combinatorial benefit in the clinic.
TG4001 and avelumab have not been approved by Regulatory Authorities for treatment of HPV-16+ malignancies.
The study is a phase Ib/II trial. The primary objective of the phase Ib part is to assess the safety of the combination of TG4001 and avelumab. The primary objective of the phase II is to assess the efficacy of the combination in terms of response rate.
The phase Ib part was conducted in France in 9 patients; the phase II part is extended to other countries including UK and is planned to include at least 40 patients, out of which at least 18 patients with oropharyngeal SCCHN.
Participation in the study may last up to 27 months. The study is divided into four periods;
• Screening Period - a period of up to 21 days to check eligibility
• Treatment period - a period of up to 24 months of treatment with study drugs (TG4001 and avelumab)
• Safety follow-up period - a period of up to 90 days once study treatment has been stopped
• Survival follow-up period - once treatment and safety follow-up portions of the study are completed, patients will be contacted every 3 months.All study-specific procedures will be performed within these periods.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0015
Date of REC Opinion
19 Mar 2020
REC opinion
Further Information Favourable Opinion