ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT05542407
Phase
PHASE1
Status
Recruiting
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Conditions

  • Carcinosarcoma
  • Clear Cell Endometrial Carcinoma
  • Endometrial Cancer
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrioid Endometrial Cancer
  • Metastasis
  • Serous Adenocarcinoma of Endometrium (Diagnosis)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    10 mg/kg- 20 mg/kg Atezolizumab will be administered by intravenous, on day 1 of each 21-day cycle.
  • ONC201 — DRUG
    375 mg once weekly - 625 mg ONC201 will be administered orally, once or twice weekly.

Study Details

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.

Key Dates

Start date
Oct 23, 2023
Status verified
Jan 2026
Primary completion
Feb 21, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Obese
    Subjects with BMI \> 30 kg/m2
  • Experimental: Non-Obese
    Subjects with BMI ≤ 29.9 kg/m2

Primary Outcome Measure

Recommended phase 2 dose (RP2D) [ Time Frame: Up to 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Melisa Ramirez-Pineda
[email protected]
919-966-5996
Victoria Bae-Jump, M.D., PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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