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NCT05542407 · ClinicalTrials.gov registry record · Phase 1
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
A Phase 1 study of Endometrial Cancer and Metastasis, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT05542407 is a Phase 1 study of Endometrial Cancer and Metastasis that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 58 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05542407, a Phase 1 study of Endometrial Cancer and Metastasis, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Atezolizumab
- DRUG ONC201
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05542407
The ClinicalTrials.gov registry entry for NCT05542407 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (89% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.
NCT05542407 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05542407 about?
NCT05542407 is a clinical study titled "ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer". 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 c...
What is the current status of trial NCT05542407?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2023-10-23. Estimated completion is 2028-07-31.
What conditions does trial NCT05542407 study?
This clinical trial studies the following conditions: Endometrial Cancer, Metastasis, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrioid Endometrial Cancer.
What interventions are being tested in trial NCT05542407?
The interventions under investigation include: Atezolizumab (DRUG), ONC201 (DRUG).
Who is sponsoring clinical trial NCT05542407?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05542407 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.