Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
UNC Lineberger Comprehensive Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria 1. Ability to understand and willingness to sign a written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of 0, 1, or 2 4. Histologically confirmed metastatic or recurrent EC (endometrioid, carcinosarcoma, serous, clear cell, adeno-squamous and mixed histologies). 5. Subjects must have measurable disease, defined as at least on…
Interventions
- DrugAtezolizumab
10 mg/kg- 20 mg/kg Atezolizumab will be administered by intravenous, on day 1 of each 21-day cycle.
- DrugONC201
375 mg once weekly - 625 mg ONC201 will be administered orally, once or twice weekly.
Location
- Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina