CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 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/NCT04646005
NCT04646005Phase 2Completed
CompareCT.gov

A Phase 2 Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

Regeneron Pharmaceuticals·interventional·Posted Nov 27, 2020·Updated Sep 8, 2025

In Brief

A Phase 2 clinical trial evaluating Cemiplimab and ISA101b for Cervical Cancer. Completed, enrolled 113 participants across 26 sites in 8 countries.

Detailed Summary

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: * To characterize the safety profile of cemiplimab + ISA101b * To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesBelgium, Brazil, Italy, Netherlands, Russia, South Korea, Spain, United States
CollaboratorsISA Pharmaceuticals B.V.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 27, 2020
Enrollment StartJun 28, 2021
Primary CompletionMay 22, 2023
Study CompletionMay 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.6 years ago

Interventions

Cemiplimabdrug

Administered intravenously (IV) every three weeks (Q3W)

ISA101bbiological

Administered by subcutaneous (SC) injection on day 1, day 29, and day 50