Phase I/II clinical trial - Phases précoces tumeurs solides

TG4001.12
Phases précoces tumeurs solides
Ouvert depuis le: 07.16.2019
Site: Paris
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A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies and expansion cohort to oropharyngeal squamous cell carcinoma of the head and neck (SCCHN)
Description de l'essai

The study will consist of two parts :;In the phase Ib part: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation.;In the phase II part, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm cohort of patients with HPV-16 positive oropharyngeal SCCHN.;In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.;All patients will be followed up until disease progression or death due to any cause or the date of data cut-off, whichever occurs first.