Calendario›REGN›Cemiplimab

Cemiplimab

Study of Cemiplimab in Adults With Cervical Cancer

Ensayo de REGENERON PHARMACEUTICALS, INC. en Squamous Cell Carcinoma (SCC) · Recurrent or Metastatic, Platinum-refractory Cervical Cancer (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

608

previstos

Centros

105

Fin del objetivo primario

mar 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2017.

Qué mide

Overall Survival (OS) (From first dose up to 90 following last dose (~42 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03257267), actualizada en abr 2025.