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Clinical trialNCT03669718UnknownPhase 2Interventional

A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

SponsorISA PharmaceuticalsEnrollment194HPV16 PositiveSquamous Cell Carcinoma of the Oropharynx
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

44 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • University Hospital Antwerp

    Antwerp, Belgium

Brazil
  • Dfsatr/oncologia D'Or

    Brasília, Brazil

  • Instituto Do Cancer Do Estado de Sao Paulo

    São Paulo, Brazil

Czechia
  • University Hospital Olomouc

    Olomouc, Czechia

  • Nemocnice Na Bulovce

    Prague, Czechia

France
  • Centre Léon Bérard

    Lyon, France

  • Chu la Timone

    Marseille, France

  • Antoine Lacassagne Center

    Nice, France

  • Gustave Roussy

    Paris, France

  • Hopitaux Universitaires Pitié Salpêtrière Charles Foix

    Paris, France

Germany
  • Universitaetsklinikum Ulm

    Ulm, Germany

Hungary
  • Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

    Nyíregyháza, Hungary

  • University of Pecs Department of Oncotherapy

    Pécs, Hungary

  • Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, Hungary

Italy
  • Asst Spedali Civili Brescia, Department of Medical Oncology

    Brescia, Italy

  • Azienda Ospedaliera San Paolo Polo Universitario

    Milan, Italy

  • Istituto Nazionale Dei Tumori

    Milan, Italy

  • National Cancer Institute - Irccs "fondazione G. Pascale"

    Naples, Italy

  • National Cancer Institute Regina Elena, Irccs

    Rome, Italy

Mexico
  • Consultorio de Oncología Médica

    Oaxaca City, Mexico

Netherlands
  • Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, Netherlands

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • University Medical Center Utrecht

    Utrecht, Netherlands

Poland
  • Maria Sklodowska-Curie National Institute of Oncology

    Gliwice, Poland

  • Swietokrzyskie Oncology Center Kielce

    Kielce, Poland

Spain
  • Hospital Clinic of Barcelona

    Barcelona, Spain

  • Hospital Duran I Reynals - Institut Catala Doncologia Ico

    Barcelona, Spain

  • Vall D'Hebron

    Barcelona, Spain

  • Hospital Universitario Marqués de Valdecilla Santander

    Santander, Spain

United Kingdom
  • Aberdeen Royal Infirmary

    Aberdeen, United Kingdom

  • the Royal Marsden Nhs Foundation

    Chelsea, United Kingdom

  • Guy'S Hospital

    London, United Kingdom

  • the Royal Marsden Nhs Foundation Trust

    Sutton, United Kingdom

  • Beacon Centre Musgrove Park Hospital

    Taunton, United Kingdom

United States
  • City of Hope

    Duarte, California, United States

  • Moores Cancer Center at the Uc San Diego Health

    San Diego, California, United States

  • University of California San Francisco

    San Francisco, California, United States

  • Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, United States

4 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2018
Primary completion
30 Sept 2024
Completion
30 Jun 2025
Last update posted
29 Dec 2023
Registered enrollment
194
Registry id
NCT03669718

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.