drugset / Trial / NCT05542407

ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

NCT05542407

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Endometrial cancer (EC) is the fourth most common cancer in United States women, and alarmingly, the frequency and mortality from EC continues to rise, in part due to the obesity epidemic. Obese women with EC have a 6.3-fold increased risk of death from this disease, as compared to their non-obese counterparts. Patients with advanced/recurrent EC are unlikely to be cured by surgery, conventional chemotherapy (paclitaxel + carboplatin is the standard first-line treatment), radiation, or a combination of these. Thus, new treatments for EC are desperately needed as well as a better understanding of the impact of obesity on EC biology and treatment. The purpose of this study is to test the safety of a combination of treatments, atezolizumab and ONC201, given based on body weight, to treat endometrial cancer. Using the combination of atezolizumab and ONC201, has not been approved by the Food and Drug Administration (FDA) for the treatment of endometrial cancer. This clinical trial will examine the treatment of atezolizumab + ONC201 in obese and non-obese subjects with metastatic/recurrent EC.

Timeline

Start
2023-10-23
Primary completion
2028-02-21
Completion
2028-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Atezolizumab Monoclonal antibody 20 mg/kg Intravenous
Subject Dordaviprone Small molecule 375 mg Oral
Subject Dordaviprone Small molecule 625 mg Oral