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RECRUITING
NCT05542407
PHASE1

ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2023-10-23

Completion Date

2028-07-31

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

10 mg/kg- 20 mg/kg Atezolizumab will be administered by intravenous, on day 1 of each 21-day cycle.

DRUG

ONC201

375 mg once weekly - 625 mg ONC201 will be administered orally, once or twice weekly.

Locations (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States