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This is a Phase III, randomised, open label, 3 arm, multi-centre, international study assessing the efficacy and safety of savolitinib plus durvalumab compared with sunitinib in participants with MET-driven (without co-occurring FH mutations), unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anti-cancer therapy in the metastatic setting.\nThe study will also investigate the contribution of durvalumab to the savolitinib plus durvalumab combination.

Approximately 200 participants will be randomised in a 2:1:1 ratio to one of the following intervention groups: savolitinib (600mg, oral, once daily) plus durvalumab (1500mg IV Q4W), sunitinib (50mg, oral, once daily for 4 consecutive weeks, followed by a sunitinib-free interval of 2-weeks, Q6W), or durvalumab monotherapy (1500mg IV Q4W).

Participants will continue to receive study intervention until objective radiological PD per RECIST 1.1 is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.

Depending on the preferred subsequent therapy, participants randomised to the durvalumab monotherapy arm will be eligible to switch to receive savolitinib in combination with durvalumab at the time of objective radiological PD assessed by BICR per RECIST 1.1, without any intervening systemic anti-cancer therapy following discontinuation of durvalumab monotherapy.

"},"designModule":{"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","maskingInfo":{"masking":"NONE"},"primaryPurpose":"TREATMENT"},"enrollmentInfo":{"count":148,"type":"ACTUAL"},"phases":["PHASE3"],"studyType":"INTERVENTIONAL"},"eligibilityModule":{"eligibilityCriteria":"

Inclusion Criteria:

Histologically confirmed unresectable and locally advanced or metastatic PRCC
PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay
No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
Karnofsky Score >70
At least one lesion, not previously irradiated, that can be accurately measured at baseline
Adequate organ and bone marrow function
Life expectancy ≥12weeks at Day 1

Exclusion Criteria:

History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs
Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
Active infection including HIV, TB, HBV and HCV
Active or prior documented autoimmune or inflammatory disorders
Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention

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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\nAll request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

","infoTypes":["STUDY_PROTOCOL","SAP"],"ipdSharing":"YES","timeFrame":"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.\nFor details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","url":"https://astrazenecagroup-dt.pharmacm.com/DT/Home"},"outcomesModule":{"primaryOutcomes":[{"description":"

Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.

The analysis will include all randomised participants as randomised, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.

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Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.

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