Combining ONC201 and Atezolizumab for treating obesity-related endometrial cancer
Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
This study is testing a new treatment for advanced or recurrent endometrial cancer in obese women by combining two drugs, ONC201 and atezolizumab, to see if it helps manage their cancer better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, atezolizumab, radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05542407 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women aged 18 and older with histologically confirmed metastatic or recurrent endometrial cancer who have experienced disease progression after prior treatments.
Not a fit: Patients with early-stage endometrial cancer or those who have not undergone prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for obese women suffering from advanced endometrial cancer.
How similar studies have performed: While the combination of ONC201 and atezolizumab has not been previously tested for endometrial cancer, similar approaches in other cancers have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.