NCT03257267

Study of Cemiplimab in Adults With Cervical Cancer

An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Squamous Cell Carcinoma (SCC)
• Recurrent or Metastatic, Platinum-refractory Cervical Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Intravenous (IV) administration every 3 weeks (Q3W)
DRUG	Investigator Choice (IC) Chemotherapy	IC chemotherapy options include: 1. Antifolate: Pemetrexed 2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan 3. Nucleoside analogue: Gemcitabine 4. Vinca alkaloid: Vinorelbine The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.

Timeline

• Start date: 2017-09-05
• Primary completion: 2021-03-15
• Completion: 2023-04-20
• First posted: 2017-08-22
• Last updated: 2025-04-08
• Results posted: 2022-04-06

Locations

105 sites across 14 countries: United States, Australia, Belgium, Brazil, Canada, Greece, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study