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RecruitingPhase 1

ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of atezolizumab and ONC201 together, given based on body weight, for endometrial cancer (cancer of the womb lining). It is for adults with or without obesity whose cancer has spread or come back. The FDA has not approved this drug combination for this 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be able and willing to sign consent and allow the release of personal health information.
  • Be at least 18 years old.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Have endometrial cancer that has spread or come back, confirmed by a tissue test.
  • Have at least one cancer spot that can be measured.
  • Scans must show cancer growth after at least one chemotherapy treatment course for cancer that has spread, or within 12 months after finishing chemotherapy given after surgery.
  • Be expected to live at least 3 months.
  • Have blood tests showing your organs work well enough, done within 72 hours before study treatment.

Who can't join

  • Have had ONC201 before.
  • Have had certain treatments that help the immune system attack cancer, including CD137 agonists or immune checkpoint blockers.
  • Have used another experimental drug or joined another clinical trial within 28 days before study treatment.
  • Have had chemotherapy or radiation within 4 weeks before study treatment, or have not recovered from side effects of earlier treatment.
  • Have taken antibiotics by mouth or through a vein to treat an infection within 2 weeks before study treatment. Antibiotics used to prevent infections are allowed.
  • Have recently taken medicines that boost the immune system throughout the body. The waiting time is at least 4 weeks, and may be longer depending on the drug.
  • Have taken medicines that weaken the immune system throughout the body within 2 weeks before study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC