Trials / Recruiting
RecruitingNCT05542407
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Endometrial Cancer
- Metastasis
- Endometrioid Endometrial Cancer
- Carcinosarcoma
- Serous Adenocarcinoma of Endometrium (Diagnosis)
- Clear Cell Endometrial Carcinoma
- Endometrial Endometrioid Adenocarcinoma
- Endometrial Mixed Cell Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-10-23
- Primary completion
- 2028-02-21
- Completion
- 2028-07-31
- First posted
- 2022-09-15
- Last updated
- 2026-01-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05542407. Inclusion in this directory is not an endorsement.