Combining ONC201 and Atezolizumab for treating obesity-related endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety of a new treatment approach for endometrial cancer by combining two drugs, ONC201 and atezolizumab, specifically for obese women. Given the rising incidence and mortality of endometrial cancer, particularly among obese patients, this study seeks to provide an alternative treatment option for those with advanced or recurrent disease. Participants will receive the treatment based on their body weight, and the study will assess the effectiveness of this combination in managing the cancer. The trial is particularly focused on patients who have shown disease progression after standard therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Victoria Bae-Jump, MD, PhD — UNC-Chapel Hill
• Study coordinator: De'Andrea Taylor
• Email: deandrea_taylor@med.unc.edu
• Phone: 919-966-1195

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining nab-Sirolimus and Letrozole for advanced endometrial cancer

  This study is testing if a new combination of two medications, nab-sirolimus and letrozole, can help people with advanced endometrial cancer feel better and manage their disease.

  Recruiting at 9 sites Phase 2 Aadi Bioscience, Inc. · Little Rock, Arkansas and 8 other locations · NCT05997017

• Testing nivolumab with or without ipilimumab for recurrent endometrial cancer

  This study is testing if adding ipilimumab to nivolumab can help people with recurrent endometrial cancer live longer and feel better compared to just using nivolumab alone.

  Recruiting at 122 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 137 other locations · NCT05112601

• Targeted treatments for recurrent endometrial cancer

  This study is testing different targeted treatments, with or without an immune therapy, to see if they can help people with recurrent endometrial cancer based on their tumor's genetic makeup.

  Recruiting Phase 1/2 Alliance Foundation Trials, LLC. · Duarte, California and 20 other locations · NCT04486352

• Personalized navigation to support rural and Black women with endometrial cancer

  This pilot tests a tailored patient-navigation program to help rural and Black patients with endometrial cancer access care and services.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07927244

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.