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Spots Global Cancer Trial Database for Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

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Trial Identification

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

Interventions

TG4001
Avelumab

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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