ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Trial Title: ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

NCT ID: NCT05542407

Condition: Endometrial Cancer
Metastasis

Conditions: Official terms:
Endometrial Neoplasms
Obesity
Atezolizumab
TIC10 compound

Conditions: Keywords:
Atezolizumab
ONC201
obesity

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Atezolizumab
Description: 10 mg/kg- 20 mg/kg Atezolizumab will be administered by intravenous, on day 1 of each 21-day cycle.
Arm group label: Non-Obese
Arm group label: Obese

Intervention type: Drug
Intervention name: ONC201
Description: 375 mg once weekly - 625 mg ONC201 will be administered orally, once or twice weekly.
Arm group label: Non-Obese
Arm group label: Obese

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.

Criteria for eligibility:
Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria 1. Ability to understand and willingness to sign a written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of 0, 1, or 2 4. Histologically confirmed metastatic or recurrent EC (endometrioid, carcinosarcoma, serous, clear cell, adeno-squamous and mixed histologies). 5. Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria 6. Must have radiographic disease progression after at least 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy. 7. Life expectancy of at least 3 months. 8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment. Exclusion Criteria 1. Prior treatment with ONC201. 2. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, and anti PD-L1 therapeutic antibodies 3. Treatment with another investigational agent or participation in another clinical trial within the last 28 days prior to initiating protocol therapy. 4. Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to initiating protocol therapy. 5. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of protocol therapy Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 6. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of protocol therapy. 7. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti TNF-agents) within 2 weeks prior to initiation

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Lineberger Comprehensive Cancer Center

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Status: Recruiting

Contact:
Last name: Melisa Ramirez-Pineda

Phone: 919-966-5996
Email: Melisa_Ramirez-Pineda@med.unc.edu

Investigator:
Last name: Victoria Bae-Jump, M.D., PhD
Email: Principal Investigator

Start date: October 23, 2023

Completion date: July 31, 2025

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: Genentech, Inc.
Agency class: Industry

Collaborator:
Agency: Oncoceutics, Inc.
Agency class: Industry

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05542407
http://unclineberger.org/patientcare/clinical-trials/clinical-trials