So given the data that we were, we were presented with from ourry one, where we had 14 patients with platinum resistant ovarian cancer and two complete responses, the decision was made to push forward with a phase 3 trial. Uh, again, the big question was how do you design a phase 3 trial and uh neural oncology and in collaboration with the FDA and the gynecological oncology group. Uh, came up with a forearm design, which include the combination therapy of nimbaleukin plus pembrolizumab, which was what was studied in artistry one, as well as two other arms, uh, looking at both of the single agent immune therapies, Pembrolizumab and nimbaleukin. Uh, the fourth arm, which is the control arm, which is needed for phase 3 trials, is looking at standard of care chemotherapy, and the investigators are given a choice of 4 different chemotherapies that are approved in the bladder resistant setting. To be the standard of care therapy uh arm. Uh, the randomization, uh, which happened prior to enrollment was 3 to 1 to 1 to 3 with 3 going into the combination, uh, 1 going into each single agent arms, and 3 going into arm 4, which is the control arm. Given the historical data that we had with Pembrolizumab, uh, with a response rate of around 10%. Um, we made the decision, the decision, excuse me, the decision was made early on that both arms 2 and 3, which were the single agent immune therapy, should have early stopping rules if we don't see a signal because the last thing we'd like to do is enroll a lot of patients on an arm that we're not convinced may have single agent activity. And and so the decision was made in both of those arms if a signal was not seen early enough that they would be closed early for futility and enrollment would continue in the combination. Uh, as well as, uh, the control arms. All of these patients were platinum resistant that went on to the trial. All of them, or none of them had received immune checkpoint inhibitor, and all of them had to have had prior treatment with bevacizumab. And if patients were known to be BRCA mutation positive, they had to have had prior treatment with PARP inhibitors as well. All the patients on this trial had measurable disease.
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