MITO END-3: A Randomized Phase II Trial of Avelumab Plus Carboplatin and Paclitaxel Compared to Carboplatin and Paclitaxel in Advanced or Recurrent Endometrial Cancer

Adding checkpoint inhibitors to first-line chemotherapy might improve the outcome of advanced/recurrent endometrial cancer (EC) patients. MITO END3 is a randomized phase II trial comparing avelumab plus carboplatin/paclitaxel versus carboplatin/paclitaxel in patients with advanced/recurrent EC and ECOG performance status 0-1. Primary endpoint was progression-free survival (PFS); superiority of the experimental arm was tested with 80% power and one-tailed alpha 0·20; subgroup analyses according to mismatch repair (MMR) status were planned. ClinicalTrials.gov NCT03503786.