1. Histologically confirmed Papillary Renal Cell Carcinoma, which is unresectable and locally advanced or metastatic with measurable disease as per RECIST 1.1.
2. Confirmation of MET-driven PRCC without co-occurring Fumarate Hydratase or Von Hippel Lindau mutations from a tumour sample using the sponsor-designated central laboratory validated MET Next Generational Sequencing assay
3. Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC. Patients who have received prior therapy must have had disease progression within 6 months of the last dose of previous systemic therapy
4. Adequate haematological, renal (creatinine < 2xULN), cardiac and liver functions
5. Karnofsky performance status ≥ 80
6. Ability to swallow oral medicines.
1. Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days from the date of randomisation or 5 half-lives of the agent, whichever is longer. Most recent non-cytotoxic targeted therapy <14 days from the date of randomisation.
2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
3. Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 weeks before the date of randomisation.
4. History of serious liver disease
5. Serious active infection or gastrointestinal disease
6. Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy)
|Maximum Eligible Age:||130 Years|
|Minimum Eligible Age:||18 Years|