Spots Global Cancer Trial Database for Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer
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Trial Identification
Brief Title: Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer
Official Title: A Multi-Centre, Open-label Phase 2a Trial of the Combination of VB10.16 and Atezolizumab in Patients With Advanced or Recurrent, Non-resectable HPV 16-Positive Cervical Cancer
Study ID: NCT04405349
Study Description
Brief Summary: This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care.
Detailed Description: Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period. Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Hopital de Libramont, Bruxelles, , Belgium
Universitair Ziekenhuis Gent (Uz Gent), Gent, , Belgium
Chu Ucl Namur, Namur, , Belgium
Multiprofile Hospital for Active Treatment for Women's Health - Nadezhda Sofia, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Serdika"" EOOD, Sofia, , Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed, Sofia, , Bulgaria
Masaryk Memorial Cancer Institute, Brno, , Czechia
Nemocnice Pardubickeho Kraje Pardubicka Nemocnice, Pardubice, , Czechia
University Hospital Kralovske Vinohrady, Praha, , Czechia
Nemocnice Na Bulovce, Praha, , Czechia
Universitatsklinikum Augsburg, Augsburg, , Germany
University Clinic Carl Gustav Carus, Dresden, , Germany
Universitatsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Medizinische Fakulat Mannheim Der Universitat Heidelberg, Heidelberg, , Germany
Oslo University Hospital, Oslo, , Norway
Jagielońskie Centum Innowacji, Centrum Badań Klinicznych JCI, Kraków, , Poland
Wielkopolskie Centrum Onkologii, Poznań, , Poland
'Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Warsaw, , Poland
Contact Details
Name: Siri Torhaug, MD
Affiliation: Nykode Therapeutics ASA
Role: STUDY_DIRECTOR
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