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NCT05061420 · ClinicalTrials.gov registry record · Phase 2
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT05061420 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 59 participants.
The verdict
NCT05061420, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
The study was a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study was structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who were treatment-naïve for recurrent and/or metastatic (R/M) disease. Substudy 4-Cohort B1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen. Substudy 5-Cohort B2 aimed to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen \& cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.
Interventions
- DRUG Pembrolizumab
- DRUG Cetuximab
- DRUG SAR444245 (Thor-707)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2024-11-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05061420
The ClinicalTrials.gov registry entry for NCT05061420 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05061420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05061420 about?
NCT05061420 is a clinical study titled "A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)". The study was a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study was structured as a master protocol for the inves...
What is the current status of trial NCT05061420?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2021-10-08. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT05061420?
The interventions under investigation include: Pembrolizumab (DRUG), Cetuximab (DRUG), SAR444245 (Thor-707) (DRUG).
Who is sponsoring clinical trial NCT05061420?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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