Trial results for the Phase 2 study (NCT05036681) investigating the combination of futibatinib and pembrolizumab in metastatic microsatellite stable (MSS) endometrial carcinoma were posted on ClinicalTrials.gov on 2025-09-17. The study, which was subsequently terminated, reported 1 objective response among enrolled participants.
Background
The study aimed to explore the combination therapy of futibatinib with pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma. The goal was to provide a well-tolerated regimen for durable responses in this patient population.
Trial design
The study (NCT05036681) was a Phase 2 trial. It enrolled 9 participants with metastatic cancer, specifically endometrial carcinoma, who had microsatellite stable (MSS) disease. The trial investigated the combination of futibatinib and pembrolizumab.
Key results
The trial reported outcomes for 'Dose Level 1' participants. For the objective of evaluating the Objective Response Rate (ORR) of futibatinib and pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma, there was 1 participant with PR/CR (partial response/complete response).
Regarding Progression Free Survival, the median was 87 days. For Overall Survival, the median was 157 days.
What this means
The termination of this Phase 2 study and the reported outcomes suggest that the combination of futibatinib and pembrolizumab in metastatic microsatellite stable endometrial carcinoma did not demonstrate sufficient efficacy to continue. The observation of only 1 objective response among 9 enrolled participants, alongside median progression-free survival of 87 days and overall survival of 157 days, indicates limited clinical benefit in this specific patient population under the study conditions.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05036681, titled 'A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma,' were posted on 2025-09-17 on clinicaltrials.gov.