Endometrial CancerPhase 1NCT05542407
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
A Phase 1 study testing Atezolizumab and ONC201 in people with Endometrial Cancer and Metastasis, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Metastasis, Endometrioid Endometrial Cancer
- What is being tested?
- Atezolizumab and ONC201
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 31 Jul 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0, 1, or 2
- Histologically confirmed metastatic or recurrent EC (endometrioid, carcinosarcoma, serous, clear cell, adeno-squamous and mixed histologies).
- 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
- 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.
- Life expectancy of at least 3 months.
- Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.
Who cannot join
- Prior treatment with ONC201.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, and anti PD-L1 therapeutic antibodies
- Treatment with another investigational agent or participation in another clinical trial within the last 28 days prior to initiating protocol therapy.
- 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.
- 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.
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Melisa Ramirez-Pineda, 919-966-5996, Melisa_Ramirez-Pineda@med.unc.edu
Victoria Bae-Jump, M.D., PhD
About this study
Official title: Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
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.
- Conditions
- Endometrial Cancer, Metastasis, Endometrioid Endometrial Cancer, Carcinosarcoma, Serous Adenocarcinoma of Endometrium (Diagnosis), Clear Cell Endometrial Carcinoma
- Being tested
- Atezolizumab, ONC201
- Keywords
- Atezolizumab, ONC201, obesity
- Medical subject headings
- Endometrial Neoplasms, Neoplasm Metastasis, Carcinosarcoma, Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
10 mg/kg- 20 mg/kg Atezolizumab will be administered by intravenous, on day 1 of each 21-day cycle.
ONC201Drug
375 mg once weekly - 625 mg ONC201 will be administered orally, once or twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | Subjects with BMI > 30 kg/m2 Receives: Drug: Atezolizumab; Drug: ONC201 |
| Non-Obese | Experimental | Subjects with BMI ≤ 29.9 kg/m2 Receives: Drug: Atezolizumab; Drug: ONC201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2 dose (RP2D)
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.
Measured: Up to 3 weeks
Secondary outcomes (3)
Overall Response Rate (ORR)
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.
Measured: Up to 2 years
Progression Free Survival (PFS)
PFS is defined as time from first day of treatment until disease progression as defined by RECIST v1.1 or death from any cause.
Measured: Up to 2 years
Overall Survival (OS)
OS is defined as the time of the start of study treatment to death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start23 Oct 2023
- Primary completion21 Feb 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Oncoceutics, Inc., National Cancer Institute (NCI), Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Victoria Bae-Jump, MD, PhD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542407
- Sponsor's protocol ID
- LCCC2036
- Other IDs
- 5R21CA267584
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.