Trial results for the Phase 2 study NCT05263492, investigating pembrolizumab in combination with lenvatinib for recurrent endometrial cancer in Black participants, were posted on ClinicalTrials.gov on 2025-10-02. The study was terminated prematurely, with all 4 enrolled participants discontinuing treatment due to treatment-related adverse events.

Background

The study investigated the combination of pembrolizumab and lenvatinib for the treatment of mismatch repair-proficient recurrent endometrial cancer specifically in Black participants.

Trial design

The study NCT05263492 was a Phase 2 trial designed to determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants with mismatch repair-proficient recurrent endometrial cancer. The trial had an enrollment of 4 participants and was ultimately terminated. Interventions included lenvatinib and pembrolizumab.

Key results

The trial reported on the number of participants experiencing treatment-related adverse events and discontinuing treatment due to these events. For the outcome "Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population," 4 participants in the Pembrolizumab & Lenvatinib group experienced treatment-related adverse events.

Additionally, for the outcome "Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs)," 4 participants in the Pembrolizumab & Lenvatinib group discontinued treatment due to treatment-related adverse events.

What this means

The termination of this Phase 2 trial and the discontinuation of all 4 enrolled participants due to treatment-related adverse events indicate significant safety and tolerability challenges for the combination of pembrolizumab and lenvatinib in this specific patient population. These results suggest that the regimen, as studied, was not tolerable, leading to the premature cessation of the investigation into its efficacy.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05263492, titled "Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer," were posted on 2025-10-02 on clinicaltrials.gov.