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NCT05603910 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma
A Phase 1 study of Recurrent Endometrial Carcinoma and Unresectable Endometrial Carcinoma, sponsored by Aaron Wolfson.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05603910: Recruiting Phase 1 study of Recurrent Endometrial Carcinoma and Unresectable Endometrial Carcinoma, sponsored by Aaron Wolfson.
NCT05603910 is a Phase 1 study of Recurrent Endometrial Carcinoma and Unresectable Endometrial Carcinoma that is actively recruiting participants, run by Aaron Wolfson. The registered enrollment target is 18 participants, below the 252-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05603910, a Phase 1 study of Recurrent Endometrial Carcinoma and Unresectable Endometrial Carcinoma, is actively recruiting participants, sponsored by Aaron Wolfson.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to see if it is feasible to combine a fixed dose of pembrolizumab and a daily dose of oral lenvatinib, along with daily treatments of an abbreviated course of pelvic external beam radiation therapy, to support cancer cells in multiplying and spreading to other body sites.
Primary Outcome
The RP2D will be the highest dose of Lenvatinib that in combination with Pembrolizumab and Hypofractionated (HypoFx) pelvic External Beam Radiotherapy (EBRT) yields less than 2 Dose Limiting Toxicities (DLTs) in 6 patients.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Hypofractionated External Beam Radiation Therapy
- DRUG Lenvatinib
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-04-15 |
| Est. Completion | 2030-04-15 |
| Phase | Phase 1 |
What NCT05603910 shows while recruiting
NCT05603910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 252-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05603910 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05603910 about?
NCT05603910 is a clinical study titled "Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma". The purpose of this research study is to see if it is feasible to combine a fixed dose of pembrolizumab and a daily dose of oral lenvatinib, along with daily treatments of an abbreviated course of pelvic external beam radiation therapy, to support cancer cells in multiplying and spreading to other b...
What is the current status of trial NCT05603910?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-04-15. Estimated completion is 2030-04-15.
What conditions does trial NCT05603910 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Unresectable Endometrial Carcinoma.
What interventions are being tested in trial NCT05603910?
The interventions under investigation include: Pembrolizumab (DRUG), Hypofractionated External Beam Radiation Therapy (RADIATION), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05603910?
This trial is sponsored by Aaron Wolfson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05603910 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05603910's enrollment target sits among peer trials
18 18th of 19 higher than 1 of 19 other Recurrent Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Endometrial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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