OncoMatch/Clinical Trials/NCT05542407
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
Is NCT05542407 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Atezolizumab and ONC201 for endometrial cancer.
Treatment: Atezolizumab · ONC201 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic cytotoxic chemotherapy — metastatic or adjuvant
Must have radiographic disease progression after at least 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy
Cannot have received: ONC201 (ONC201)
Prior treatment with ONC201
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint inhibitor (anti-CTLA-4, anti-PD-L1)
Prior treatment with ... immune checkpoint blockade therapies, including antiCTLA-4, and anti PD-L1 therapeutic antibodies
Lab requirements
Blood counts
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.
Kidney function
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.
Liver function
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
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