Last updated on March 2019

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers and Expansion Cohort to Oropharyngeal SCCHN

Brief description of study

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.

Clinical Study Identifier: NCT03260023

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Toulouse, France
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