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
Completed · Phase 2
Conditions studied: Cervical Cancer
In brief
The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: * To characterize the safety profile of cemiplimab + ISA101b * To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
Key facts
- Study ID
- NCT04646005
- Run by
- Regeneron Pharmaceuticals
- People needed
- 113
- Starts
- 2021-06-28
- Expected to finish
- 2024-05-29
- Last updated by the study team
- 2025-09-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Arizona Oncology Associates — Tucson, Arizona, United States
- Arizona Oncology Associates — Tucson, Arizona, United States
- Regeneron Research Site — Orange, California, United States
- Universitair Ziekenhuis Gent — Ghent, East Flanders, Belgium
- UZ Leuven — Leuven, Vlaams Brabant, Belgium
- CHIREC Delta Hospital / Chirec Cancer Institute — Brussels, Belgium
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA — Santo Cristo, Rio de Janeiro, Brazil
- Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- Centro De Novos Tratamentos Itajai — Itajaí, Santa Catarina, Brazil
- Fundacao Pio XII - Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil
- Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA) — Rio de Janeiro, Brazil
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS — Meldola, Emilia-Romagna, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy
- IRCCS-Istituto Europeo di Oncologia — Milan, Italy
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands
- University Medical Center Groningen — Groningen, Netherlands
- Leiden Universitair Medisch Centrum (LUMC) — Leiden, Netherlands
- Radboudumc — Nijmegen, Netherlands
- State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region — Krasnodar, Krasnodarskiy Kray, Russia
- Seoul National University Hospital — Seoul, South Korea
- University of Ulsan College of Medicine - Asan Medical Center (AMC) — Seoul, South Korea
- Gangnam Severance Hospital — Seoul, South Korea
- Korea University Guro Hospital — Seoul, South Korea
- Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO) — Girona, Catalonia, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.