ANZGOG’s ADELE study is a randomised phase 2 trial that aims to improve outcomes for women with high-risk endometrial cancer.
Led by Principal Investigator Prof Linda Mileshkin & co-chair Dr Yeh Chen Lee, the study is open at 10 sites across Australia and aims to open 13 more sites in ANZ, with a target of recruiting 135 participants.
ADELE is testing the effect of ADjuvant tislelizumab plus chemotherapy after post-operative pelvic chemoradiation in high risk EndometriaL cancer: a randomised phase 2 trial.
“Given increasing evidence that immunotherapy can benefit some women with advanced endometrial cancer, we hope that adding this to standard treatment in the post operative setting for those with high risk disease may help to improve outcomes for women”
ADELE Principal Investigator – Prof Linda Mileshkin
Prof Mileshkin comments, “Endometrial cancer is the most common and increasing gynaecological cancer in Australia. Standard primary treatment is hysterectomy, however 30% of women with more advanced disease or high-risk histology may not be cured with surgery alone. Current standard adjuvant therapy involves a combination of adjuvant chemotherapy and radiation. We plan to test if these outcomes can be improved by adding immunotherapy, which has shown promising results in relapsed endometrial cancer, to standard adjuvant therapy. We propose to undertake a multi-centre randomized phase 2 trial in which women with high-risk endometrial cancer would be randomized to receive standard adjuvant therapy with chemoradiation to the pelvis followed by adjuvant chemotherapy or the same adjuvant regimen with the addition of concurrent followed by maintenance immune checkpoint inhibitor therapy. Participants would be randomized 2:1 to the intervention arm and stratified by whether or not their tumour is mismatch repair deficient or proficient given the likely differential responses to immunotherapy in these molecular subsets.
The aim of the trial is to determine if patient outcomes can be improved by the adding immune checkpoint inhibitor therapy to standard adjuvant therapy for high-risk Endometrial Cancer (EC).
ADELE Principal Investigator, Professor Linda Mileshkin
The Primary objective is to determine the feasibility of delivering the combined adjuvant immunotherapy. Secondary objectives are to determine the: failure free survival rate, adverse event profile, treatment completion rate and, the impact on quality of life. Translational research objectives are to assess the association between clinical outcomes and potential predictive/prognostic biomarkers including PD-L1, mismatch repair status, tumour infiltrating lymphocytes and longitudinal change in ctDNA.”
ADELE is an ANZGOG study in collaboration with the NHMRC Clinical Trials Centre, at the University of Sydney, and funded by the Medical Research Future Fund.
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