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NCT05603910 · ClinicalTrials.gov record · last posted 2026-08-03

Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma

StatusRecruiting
PhasePhase 1
Started2023-04-15
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from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-04
critical
Primary endpoint(s) modified
WasNumber of Events of Treatment-Related Toxicity, Recommended Phase 2 Dose (RP2D) of Lenvatinib
NowNumber of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs), Number of Participants Experiencing Treatment-Related Toxicity: Dose-Limiting Toxicities (DLTs), Recommended Phase 2 Dose (RP2D) of Lenvatinib
2026-08-04
critical
Primary completion pushed: 2027-04-15 → 2029-04-15
2026-08-04
minor
Completion pushed: 2030-04-15 → 2034-04-15
Trial Details
NCT Number NCT05603910
Lead Sponsor Aaron Wolfson
Conditions Recurrent Endometrial Carcinoma, Unresectable Endometrial Carcinoma
Enrollment 18 participants
Start Date 2023-04-15
Primary Completion 2029-04-15 (estimated)
Study Completion 2034-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-03