Documented response to Opdivo+Yervoy in a Patient With Refractory ASPS

[D.ap]

Positive Tumor Response to Combined Checkpoint Inhibitors in a Patient With Refractory Alveolar Soft Part Sarcoma: A Case Report

http://ascopubs.org/doi/full/10.1200/JGO.2017.009993

[Olga]

Interesting case from Europe. They used a combination first - nivolumab (OPDIVO in US) and Ipilimumab (Yervoy) - for two cycles and after continued on OPDIVO only, with the 69% regression so far. Interesting was their observation of the initial response when there was a demonstrated decrease in the size of bilateral metastatic pulmonary nodules, but the liver metastasis and some of the extensive peritoneal implants slightly increased in size, with a decrease in intratumoral density. As we now know it is a sign of the pseudoprogression. That was confirmed later by the next scanning - after four cycles of this combination therapy, the patient achieved a partial response (−51% from baseline), on the basis of Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST), with a substantial decrease in the size of multiple bilateral pulmonary metastases, liver metastases, and peritoneal implants.
I am wondering how they deal it in a clinical trial setting when the mixed response like in the beginning would disqualify the patient from the trial...