RecruitingPhase 1NCT05542407

ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

58 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Metastasis Endometrial Endometrioid Adenocarcinoma Endometrial Mixed Cell Adenocarcinoma Endometrioid Endometrial Cancer Carcinosarcoma Serous Adenocarcinoma of Endometrium (Diagnosis)Clear Cell Endometrial Carcinoma

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of ONC201 (a drug that targets a protein inside cancer cells' mitochondria, or energy centers) with atezolizumab (an immunotherapy drug) for women with advanced or recurrent endometrial (uterine) cancer that is associated with obesity. Obesity-related endometrial cancers often have specific characteristics that may make them more likely to respond to this combination. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with metastatic or recurrent endometrial cancer (confirmed by biopsy) - Your cancer has measurable tumors on scans - Your cancer has progressed after at least one prior line of chemotherapy - Your general health is adequate (ECOG score 0–2) **You may NOT be eligible if:** - You have not had prior systemic chemotherapy - Your cancer does not meet the required endometrial histology type - You have severe autoimmune disease or are on immunosuppressive drugs - You have active or uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT05542407

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