NCT04197219

Pembrolizumab With Axitinib in Recurrent Endometrial Cancer

Pembrolizumab With Axitinib in Recurrent Endometrial Cancer With Deficient Mismatch Repair System Post PD1 Exposure: Phase II Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to see if adding the experimental medication, axitinib, to usual treatment with pembrolizumab will work better than pembrolizumab alone. The study team will look at overall safety and side effects of the combination of axitinib and pembrolizumab to see how well it is tolerated. Researchers will also want to take some research blood samples to explore what effects the combination of treatment has on participants' cells and immune system and to see if there are things in participants' blood that can predict a response or resistance to the combined treatment.

Detailed description

This is a Phase 2, open label study of pembrolizumab in combination with axitinib in adult women with recurrent endometrial cancer with deficient mismatch repair system. Twenty-six participants in total will be enrolled into the study. All participants enrolled will receive pembrolizumab as standard of care combined with axitinib. Axitinib is approved by the Food and Drug Administration (FDA) for treatment in certain participants with advanced renal cell cancer but is considered investigational (experimental) in this study. However, it is not FDA approved for recurrent endometrial cancer. Axitinib is a type of drug called a tyrosine kinase inhibitor. It is thought to work by blocking tumor vasculature and decreasing the blood supply to the tumor. Also it has been shown to improve the function of immune cells within the tumor which may enable them to kill the tumor. Pembrolizumab is an immunotherapy that is FDA approved to treat participants with recurrent endometrial cancer with deficient mismatch repair system (dMMR). dMMR means having genetic changes within the tumor that make it unstable and potentially able to benefit from immunotherapy. Pembrolizumab works by improving the function of the immune cells enabling them to kill cancer cells. Axitinib given in combination with pembrolizumab has not been tested for endometrial cancer. In this study the combination of axitinib and pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA).

Conditions

• Recurrent Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg IV day 1 of each cycle every 21 days
DRUG	Axitinib	5 mg PO BID continuously

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-01-01
• Completion: 2026-12-01
• First posted: 2019-12-13
• Last updated: 2020-11-05

Regulatory

• FDA-regulated drug study