Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

June 28, 2021

Primary Completion Date

May 22, 2023

Study Completion Date

May 29, 2024

Conditions
Cervical Cancer
Interventions
DRUG

Cemiplimab

Administered intravenously (IV) every three weeks (Q3W)

BIOLOGICAL

ISA101b

Administered by subcutaneous (SC) injection on day 1, day 29, and day 50

Trial Locations (26)

1160

CHIREC Delta Hospital / Chirec Cancer Institute, Brussels

3000

UZ Leuven, Leuven

9000

Universitair Ziekenhuis Gent, Ghent

17007

Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO), Girona

20141

IRCCS-Istituto Europeo di Oncologia, Milan

28046

Hospital Universitario La Paz, Madrid

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola

85704

Arizona Oncology Associates, Tucson

85711

Arizona Oncology Associates, Tucson

92868

Regeneron Research Site, Orange

350040

State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region, Krasnodar

20220-410

Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA, Santo Cristo

90610-000

Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

88301-220

Centro De Novos Tratamentos Itajai, Itajaí

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos

22793-080

Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA), Rio de Janeiro

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

6229 HX

Maastricht University Medical Center, Maastricht

9713 GZ

University Medical Center Groningen, Groningen

2333 ZA

Leiden Universitair Medisch Centrum (LUMC), Leiden

6525 GA

Radboudumc, Nijmegen

03080

Seoul National University Hospital, Seoul

05505

University of Ulsan College of Medicine - Asan Medical Center (AMC), Seoul

06273

Gangnam Severance Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ISA Pharmaceuticals B.V.

INDUSTRY

lead

Regeneron Pharmaceuticals

INDUSTRY

NCT04646005 - Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy | Biotech Hunter | Biotech Hunter