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Monoclonal Antibodies

ONC201 + Atezolizumab for Endometrial Cancer

Phase 1

Recruiting

Led By Victoria Bae-Jump, MD, PhD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests a combination of treatments to treat endometrial cancer, which has a higher risk of death in obese women. It aims to find a better understanding of the impact of obesity and new treatments for the disease.

Who is the study for?

This trial is for adults over 18 with advanced or recurrent endometrial cancer, who have measurable disease and have had progression after chemotherapy. They must understand the study and consent to participate. Those with adequate organ function and a life expectancy of at least 3 months can join. People cannot join if they've had certain recent treatments, including ONC201, other clinical trials, chemotherapy, radiotherapy, immunostimulatory agents, systemic immunosuppressive medications or checkpoint blockade therapies.Check my eligibility

What is being tested?

The trial tests the safety of combining Atezolizumab and ONC201 in treating obesity-related endometrial cancer based on body weight. This combination isn't FDA-approved yet for this use. The study includes both obese and non-obese subjects with metastatic/recurrent endometrial cancer to see how well these drugs work together.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions since Atezolizumab is an immune checkpoint inhibitor that can cause inflammation in various organs; fatigue; infusion reactions; digestive issues like nausea or diarrhea; skin rash; hormonal gland problems (like thyroid); liver enzymes increase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recommended phase 2 dose (RP2D)

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: ObeseExperimental Treatment2 Interventions

Subjects with BMI > 30 kg/m2

Group II: Non-ObeseExperimental Treatment2 Interventions

Subjects with BMI ≤ 29.9 kg/m2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

ONC201

2017

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,275 Total Patients Enrolled

1 Trials studying Metastasis

50 Patients Enrolled for Metastasis

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,085 Total Patients Enrolled

Oncoceutics, Inc.Industry Sponsor

5 Previous Clinical Trials

178 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its blessing to Obese for therapeutic use?

"Due to its limited safety and efficacy data, our team assigned a score of 1 for the medication Obese on a scale from 1-3."

Answered by AI

Are any vacancies available for this clinical trial?

"Affirmative. This clinical trial is currently recruiting, with its initial posting on the 16th of August 2023 and most recent update occurring on the 7th of September 2023."

Answered by AI

What is the overall population engaged in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling patients; it was posted on August 16th 2023 and updated most recently on September 7th 2023. The study requires 58 participants from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

2023. "ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05542407.