Overview

Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

Status:
Recruiting

Trial end date:
2024-10-22

Target enrollment:

Participant gender:

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)

Phase:

Phase 2

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

ISA Pharmaceuticals B.V.

Treatments:

Cemiplimab