Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
The study will consist of two parts :
In the phase Ib: 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 1, evaluation of efficacy and further evaluation of safety of the
combination of TG4001 and avelumab will be performed in a single arm of patients with
recurrent or metastatic HPV-16 positive advanced malignancies.
In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will
be performed in a randomized, open-label controlled study comparing TG4001 in combination
with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies.
In both phases, tumor response will be evaluated on local assessment using RECIST 1.1.
All patients will be followed up until disease progression, death, or unacceptable toxicity,
or study withdrawal for any reason, whichever occurs first.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Transgene
Collaborators:
EMD Serono Research & Development Institute, Inc. Merck KGaA Merck KGaA, Darmstadt, Germany Pfizer