NCT06016920 - Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 19, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

January 31, 2028

Conditions

HPV Positive Oropharyngeal Squamous Cell CarcinomaHNSCC

Interventions

BIOLOGICAL

VB10.16

"Intramuscular (i.m.) administrations of VB10.16 every 3 weeks (Q3W) starting at Week 1/Day 1 during a 12-week induction period, followed by a maintenance period with administrations every 6 weeks (Q6W) from Week 13 until Week 48. A total of up to 10 i.m. administrations will be given.~VB10.16 will be administered via Pharma Jet® Stratis 0.5 mL needle free injection system."

DRUG

Pembrolizumab

"Pembrolizumab 200 mg intravenous (i.v.) will be given in accordance with the local regulatory-approved label Q3W starting at Week 1/Day 1 for as long as the patient tolerates and continues to have clinical benefit from the treatment based on the patient and investigator's decision, up to a maximum of 35 treatments corresponding to approximately 2 years of treatment.~After 48 weeks of treatment patients can continue on 200 mg Q3W or change to 400 mg Q6W at the discretion of the investigator and after consultation with the sponsor.~Pembrolizumab will be given by i.v. infusion over 30 minutes."

Trial Locations (17)

34298

RECRUITING

CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM), Montpellier

75013

RECRUITING

Hôpital de la Pitié - Salpétrière in Paris, Paris

Unknown

RECRUITING

Fakultni nemocnice Olomouc, Olomuoc, Olomouc

RECRUITING

Hospices Civils De Lyon, Lyon

RECRUITING

Institut Gustave Roussy, Paris, Paris

RECRUITING

Universität Leipzig Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Leipzig

RECRUITING

Orszagos Onkologiai Intezet, Budapest, Budapest

RECRUITING

University of Bergen, Haukeland University Hospital, Bergen

RECRUITING

Oslo Universitetssykehus, Oslo

RECRUITING

Uniwersyteckie Cetrum Kliniczne, Gdansk

RECRUITING

Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy Instytut, Gliwice

RECRUITING

KO-MED Centra Kliniczne Lublin II, Lublin, Lublin

RECRUITING

Hospital del Mar, Barcelona, Barcelona

RECRUITING

Institut Catala d'Oncologia, Barcelona, Barcelona

RECRUITING

Hospital Universitario Virgen de las Nieves, Granada, Granada

RECRUITING

MD Anderson Cancer Center, Madrid, Madrid

RECRUITING

East and North Hertfordshire NHS Trust Mount Vernon Hospital, London