Study of Cemiplimab in Adults With Cervical Cancer
Status:
Active, not recruiting
Trial end date:
2023-07-07
Target enrollment:
Participant gender:
Summary
The 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)