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Brief Title: Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
Official Title: A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.
Study ID: NCT03260023
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Jacksonville, Florida, United States
Mayo Clinic, Rochester, Minnesota, United States
I.C.O. Paul Papin, Angers, , France
CHU Besançon, Besançon, , France
Hôpital Saint André - CHU de Bordeaux, Bordeaux, , France
Hôpitaux Civils de Colmar - Hôpital Pasteur, Colmar, , France
CLCC Georges-François Leclerc, Dijon, , France
Centre Léon Bérard, Lyon, , France
Hopital de la Timone, Marseille, , France
Institut Curie, Paris, , France
I.C.O. Gauducheau, Saint-Herblain, , France
Centre Paul Strauss - ICANS - Institut de cancérologie Strasbourg Europe, Strasbourg, , France
Institut Claudius Regaud - IUCT - Oncopole, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
ICO Badalona - Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Virgen de las Nieves, Granada, , Spain
Fundación de Investigación biomédica H. 12 de Octubre, Madrid, , Spain
Fundación de Investigación Biomédica Hospital Clínico San Carlos, Madrid, , Spain
Hospital Virgen de La Victoria, Malaga, , Spain
Hospital General de Valencia, Valencia, , Spain