NCT05036681

A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It's propose this pilot phase 2 study to explore the combination therapy of futibatinib with pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma to provide a well-tolerated regimen for durable responses.

Detailed description

Primary Objectives * To evaluate the objective response rate (ORR) of futibatinib and pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma. * To evaluate the safety and tolerability. Primary Endpoints * Complete responses (CRs) and partial responses (PRs) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Adverse events (AEs: clinical manifestations and laboratory tests) and serious adverse events (SAEs) according to the NCI Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0.

Conditions

• Metastatic Cancer
• Endometrium Cancer
• Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Futibatinib	tablets by mouth 1 time every day
DRUG	Pembrolizumab	Given by vein over about 30-60 minutes on Day 1 of all cycles

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-09-30
• Completion: 2025-05-06
• First posted: 2021-09-08
• Last updated: 2026-03-27
• Results posted: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study