Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer (NCT03526432) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
United States110 participantsStarted 2018-08-08
Plain-language summary
This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
✓. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
✓. At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, and/or consolidation/maintenance therapy.
✓. Measurable disease by RECIST 1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm in long axis when measured by CT, MRI, or caliper measurement by clinical exam. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.
✓. Female patients 18 years or older.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
✓. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined in study protocol.
✓. Clinical laboratory values as specified in study protocol within 4 weeks before the first dose of study drug.
Exclusion criteria
✕. Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breast feeding are not eligible.
What they're measuring
1
Number of patients who experience complete or partial tumor response
✕. Previous treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody.
✕. History of auto-immune disorders (SLE, sarcoidosis, RA, Crohn's).
✕. Initiation of treatment with systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug
✕. Sensory or motor neuropathy ≥ Grade 2.
✕. Patients with symptomatic, untreated Central nervous system (CNS) metastasis; Patients with a history of treated CNS lesions are eligible if all criteria provided per study protocol are met.
✕. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, severe cardiac disease, bleeding diathesis, active infection, or any other condition that could compromise participation of the patient in the study.
✕. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.