CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 608 enrolled
Drug / intervention
Cemiplimab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03257267
NCT03257267Phase 3Completed
CompareCT.gov

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

Regeneron Pharmaceuticals·interventional·Posted Aug 22, 2017·Updated Apr 8, 2025

In Brief

A Phase 3 clinical trial evaluating Cemiplimab and Investigator Choice (IC) Chemotherapy for Squamous Cell Carcinoma (SCC) and Recurrent or Metastatic, Platinum-refractory Cervical Cancer. Completed, enrolled 608 participants across 105 sites in 14 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer
CountriesAustralia, Belgium, Brazil, Canada, Greece, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 22, 2017
Enrollment StartSep 5, 2017
Primary CompletionMar 15, 2021
Study CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.9 years ago

Interventions

Cemiplimabdrug

Intravenous (IV) administration every 3 weeks (Q3W)

Investigator Choice (IC) Chemotherapydrug

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.