Trials / Completed
CompletedNCT04646005
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cemiplimab | Administered intravenously (IV) every three weeks (Q3W) |
| BIOLOGICAL | ISA101b | Administered by subcutaneous (SC) injection on day 1, day 29, and day 50 |
Timeline
- Start date
- 2021-06-28
- Primary completion
- 2023-05-22
- Completion
- 2024-05-29
- First posted
- 2020-11-27
- Last updated
- 2025-09-08
- Results posted
- 2024-09-19
Locations
26 sites across 8 countries: United States, Belgium, Brazil, Italy, Netherlands, Russia, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04646005. Inclusion in this directory is not an endorsement.