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NCT04646005 · ClinicalTrials.gov registry record · Phase 2
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, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT04646005 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 113 participants.
The verdict
NCT04646005, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study 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)
Interventions
- DRUG Cemiplimab
- BIOLOGICAL ISA101b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2024-05-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04646005
The ClinicalTrials.gov registry entry for NCT04646005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab is the first listed.
NCT04646005 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04646005 about?
NCT04646005 is a clinical study titled "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". 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 as...
What is the current status of trial NCT04646005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2021-06-28. Estimated completion is 2024-05-29.
What interventions are being tested in trial NCT04646005?
The interventions under investigation include: Cemiplimab (DRUG), ISA101b (BIOLOGICAL).
Who is sponsoring clinical trial NCT04646005?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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