Actively Recruiting
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-29
58
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent and HIPAA authorization
- Female aged 18 years or older
- ECOG Performance Status of 0, 1, or 2
- Histologically confirmed metastatic or recurrent endometrial cancer (including endometrioid, carcinosarcoma, serous, clear cell, adeno-squamous, and mixed types)
- Measurable disease by RECIST criteria
- Radiographic disease progression after at least one systemic cytotoxic therapy for metastatic disease or progression within 12 months of completing adjuvant chemotherapy
- Life expectancy of at least 3 months
- Adequate organ function verified by labs within 72 hours prior to treatment
You will not qualify if you...
- Prior treatment with ONC201
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4 and anti-PD-L1 antibodies
- Participation in another investigational trial or treatment with another investigational agent within 28 days prior to study treatment
- Chemotherapy or radiotherapy within 4 weeks prior to study treatment or unresolved adverse events from such treatments
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to study treatment (prophylactic antibiotics allowed)
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives prior to study treatment
- Treatment with systemic immunosuppressive medications within 2 weeks prior to study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
D
De'Andrea Taylor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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