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ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

NCT05542407 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-01-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Oncoceutics, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Victoria Bae-Jump, MD, PhD · UNC-Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2028-02-21
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542407 on ClinicalTrials.gov