Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC

Inclusion criteria

• . Age ≥ 18 years on the day of signing informed consent.
• . Metastatic or locally advanced (inoperable) type 2 or mixed PRCC, histologically confirmed by central review: FFPE blocks (or all HES and IHC slides) with the initial histology report must be sent for central reading before confirmation of inclusion in the study.
• . No prior systemic treatment for renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) even in adjuvant setting.
• . At least one measurable site of disease according to RECIST v1.1.
• . Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 evaluated within 7 days prior to the date of inclusion.
• . In case of prior radiation therapy, discontinuation of irradiation for at least 3 weeks before first dose of study treatment, with at least 1 site kept/preserved for evaluation. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks - limited field (\<10% of the whole body)) to non-CNS disease.
• . Adequate bone-marrow, hepatic, and renal functions within 14 days prior to the inclusion, with:
• . Absence of significant proteinuria (\<0.5 g/24h) confirmed by urinary dipstick test. If the dipstick test is ≥ 2+, proteinuria will be quantitated on a complete 24h urine sample (\< 1 g/l of protein/24h sample)

Exclusion criteria