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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: Recruiting Phase 1 study of Endometrial Cancer and Metastasis, sponsored by UNC Lineberger Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The RP2D will be determined based on the incidence of dose-limiting toxicities (DLT)s. A DLT is defined as all grade 3 or above toxicities that are related to study treatment and occur within the first cycle of therapy. Adverse events are assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE). A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Modera
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 |
What NCT05542407 shows while recruiting
NCT05542407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05542407's enrollment target sits among peer trials
58 121st of 181 higher than 61 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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