Study of Cemiplimab in Adults With Cervical Cancer
Completed · Phase 3
Conditions studied: Squamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer
In brief
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)
Key facts
- Study ID
- NCT03257267
- Run by
- Regeneron Pharmaceuticals
- People needed
- 608
- Starts
- 2017-09-05
- Expected to finish
- 2023-04-20
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Arizona Oncology Associates — Tucson, Arizona, United States
- University of California Irvine — Orange, California, United States
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States
- Cancer Research for the Ozarks — Springfield, Missouri, United States
- New York Presbyterian Queens — Flushing, New York, United States
- Northwell Health — Lake Success, New York, United States
- Laura and Issac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
- First Health of the Carolinas Outpatient Cancer Center — Pinehurst, North Carolina, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Texas Oncology, P.A. — Austin, Texas, United States
- St. George Hospital — Kogarah, New South Wales, Australia
- Northern NSW Health District, The Tweed Hospital — Tweed Heads, New South Wales, Australia
- Royal Brisbane & Women's Hospital — Herston, Queensland, Australia
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- St. John of God Subiaco Hospital — Subiaco, Western Australia, Australia
- OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie — Aalst, Belgium
- Institut Bordet — Brussels, Belgium
- Cliniques universitaires Saint-Luc — Brussels, Belgium
- UZLeuven Gynaelologic Oncology — Leuven, Belgium
- CHC Saint Joseph — Liège, Belgium
- CHU Liège — Liège, Belgium
- CHU UCL Namur site Sainte Elisabeth — Namur, Belgium
- Liga Norte Riograndense Contra o Câncer — Natal, Rio Grande do Norte, Brazil
- Arizona Oncology Associates — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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