Use the hyperlinks, where available to access additional clinical trial information.
The effect of adjuvant tislelizumab plus chemotherapy on failure free survival after post-operative pelvic chemoradiation in high risk endometrial cancer - ADELE: a randomised phase 2 trial
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Other Non-Commercial Sponsor
University of Sydney
Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of tislelizumab and carboplatin plus paclitaxel chemotherapy, followed by tislelizumab alone for another 8 cycles. In the Active Comparator Arm, participants will receive a sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of carboplatin plus paclitaxel chemotherapy. Pelvic chemoradiation should commence within 4-6 weeks after surgery, but no later than 8 weeks, and prior to chemotherapy +/- immunotherapy. Pelvic chemoradiation will be at a dose of 45Gy in 25 fractions, delivered to the clinical target volume 5 days a week for 5 weeks. Tislelizumab (200mg) will be be administered via intravenous infusion (IV) once every 3 weeks for up to 12 cycles, and carboplatin (AUC 5) and paclitaxel (175mg/m^2) will also be administered via IV once every 3 weeks.