Title:
Atezolizumab Trial in Endometrial Cancer – AtTEnd (AtTEnd)
Principal Investigator:
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Nicoletta Colombo, MD, of the Istituto Europeo di Oncologia (IEO)-Milan
Description:
The primary objective of the study is to evaluate atezolizumab given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.
Patients enrolled in the experimental arm will receive atezolizumab in combination with paclitaxel and carboplatin. The control arm is treatment with placebo in combination with paclitaxel and carboplatin.
Primary outcome measures include progression-free survival and overall survival, with secondary endpoints including objective response rate, duration of response, safety, quality of life, and compliance.
Participants with newly diagnosed, histologically confirmed with residual disease after surgery either measurable or evaluable, or inoperable stage III-IV endometrial carcinoma/carcinosarcoma, after diagnostic biopsy, and naive to first-line systemic anticancer treatment are eligible for enrollment. Recurrent endometrial cancer patients can also enroll, provided they have not yet been treated for recurrent disease.
A formalin-fixed paraffin-embedded tumor sample or at least 20 unstained slides from initial surgery or from diagnostic biopsy must be available to be sent to a central laboratory for microsatellite determination prior to randomization.
Patients with a history of autoimmune disease, prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, or anti-PDL-1 therapeutic antibodies or anti-CTLA-4 therapies are not eligible for trial enrollment. Those with uterine leiomyosarcoma and a history of other certain malignancies within the last 5 years are also not eligible for enrollment.
To review the full list of inclusion and exclusion criteria please refer to the reference.
Status: This trial is ongoing and recruiting patients as of July 27, 2018.
This study is sponsored by Hoffmann-La Roche and Mario Negri Institute for Pharmacological Research.
Reference
Clinicaltrials.gov. Atezolizumab Trial in Endometrial Cancer – AtTEnd (AtTEnd). NCT03603184. https://clinicaltrials.gov/ct2/show/NCT03603184. Accessed October 26, 2020.
