ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Phase 1

Recruiting

• Conditions: Metastasis; Endometrial Cancer
• Interventions: Drug: Atezolizumab; Drug: ONC201

• Registration Number: NCT05542407
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Study Start: 2023-10-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-02-21
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese	ONC201	Subjects with BMI \> 30 kg/m2
Non-Obese	ONC201	Subjects with BMI ≤ 29.9 kg/m2
Non-Obese	Atezolizumab	Subjects with BMI ≤ 29.9 kg/m2
Obese	Atezolizumab	Subjects with BMI \> 30 kg/m2

Primary Outcome Measures

Name	Time	Method
Recommended phase 2 dose (RP2D)	Up to 3 weeks	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 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate Instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 2 years	ORR is defined as the proportion of subjects achieving response complete response (CR) or partial response(PR) assessed by RECIST v1.1.; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions.
Overall Survival (OS)	Up to 2 years	OS is defined as the time of the start of study treatment to death from any cause.
Progression Free Survival (PFS)	Up to 2 years	PFS is defined as time from first day of treatment until disease progression as defined by RECIST v1.1 or death from any cause.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States