NCT03669718 - A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC | Biotech Hunter

Enrollment

194

Participants

Timeline

Start Date

November 30, 2018

Primary Completion Date

September 30, 2024

Study Completion Date

June 30, 2025

Conditions

Squamous Cell Carcinoma of the OropharynxHPV16 Positive

Interventions

BIOLOGICAL

ISA101b

Every 3 weeks for a total of 3 times

DRUG

Cemiplimab

Every 3 weeks for up to 24 months

OTHER

Placebo

Every 3 weeks for a total of 3 times

Trial Locations (44)

10029

ICAHN School of Medicine at Mount Sinai, New York

15232

UPMC Hillman Cancer Center, Pittsburgh

45069

University of Cincinnati Cancer Institute, Cincinnati

60208

Robert H. Lurie Comprehensive Cancer Center, Chicago

63110

Washington University School of Medicine, St Louis

77030

M. D. Anderson Cancer Center, Houston

91010

City of Hope, Duarte

92093

Moores Cancer Center at the UC San Diego Health, San Diego

94115

University of California San Francisco, San Francisco

97213

Providence Portland Medical Center, Portland

Unknown

University Hospital Antwerp, Antwerp

DFSATR/Oncologia D'Or, Brasília

Instituto do Cancer do Estado de Sao Paulo, São Paulo

University Hospital Olomouc, Olomouc

Nemocnice na Bulovce, Prague

Centre Léon Bérard, Lyon

CHU La Timone, Marseille

Antoine Lacassagne Center, Nice

Gustave Roussy, Paris

Hopitaux Universitaires Pitié Salpêtrière Charles Foix, Paris

Universitaetsklinikum Ulm, Ulm

Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Nyíregyháza

University of Pecs Department of Oncotherapy, Pécs

Hetenyi Geza Korhaz-Rendelointezet, Szolnok

ASST Spedali Civili Brescia, Department of Medical Oncology, Brescia

Azienda Ospedaliera San Paolo Polo Universitario, Milan

Istituto Nazionale dei Tumori, Milan

"National Cancer Institute - IRCCS Fondazione G. Pascale", Naples

National Cancer Institute Regina Elena, IRCCS, Rome

Consultorio de Oncología Médica, Oaxaca City

Radboud University Medical Center, Nijmegen

Maria Sklodowska-Curie National Institute of Oncology, Gliwice

Swietokrzyskie Oncology Center Kielce, Kielce

Hospital Clinic of Barcelona, Barcelona

Hospital Duran i Reynals - Institut Catala dOncologia ICO, Barcelona

Vall d'Hebron, Barcelona

Hospital Universitario Marqués de Valdecilla Santander, Santander

Aberdeen Royal Infirmary, Aberdeen

The Royal Marsden NHS Foundation, Chelsea

Guy's Hospital, London

The Royal Marsden NHS Foundation Trust, Sutton

Beacon Centre Musgrove Park Hospital, Taunton

1066CX

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

3584 CX

University Medical Center Utrecht, Utrecht