CALYPSO

Title: MEDI4736 combinations in metastatic renal cell carcinoma

Disease site: Renal cancer (clear cell and papillary)

Status: In follow up (closed to recruitment)

Trial Design: International, multicentre, open label phase Ib/IIa study of durvalumab alone, savolitinib alone, and durvalumab in combination with savolitinib or tremelimumab in patients with metastatic renal cell cancer. CALYPSO will be carried out in two phases, a dose finding phase and a dose expansion/randomised phase.

Patients with metastatic renal cell cancer, either papillary or clear cell, (irrespective of PD-L1 and MET alteration status) were enrolled in the dose finding phase. This component allowed de-escalation of both savolitinib and durvalumab doses with intensive safety monitoring to ensure patient safety. This part of the study is now closed.

The expansion phase aims to evaluate the two cohort populations separately (irrespective of PD-L1 and MET alteration status). Patients with metastatic clear cell renal cancer or sarcomatoid renal cancer will be randomised (1:1:1:1) to receive either savolitinib alone or durvalumab alone or savolitinib plus durvalumab or tremelimumab plus durvalumab. In addition, metastatic papillary cell renal cancer will receive the combination of savolitinib and durvalumab. In both disease cohorts patients will receive treatment until progression at which point they will enter a survival follow up.

Retrospective exploratory biomarker analysis results will be compared with responses to savolitinib, tremelimumab and durvalumab.