Study identifier:D5086C00001
ClinicalTrials.gov identifier:NCT05043090
EudraCT identifier:2021-000336-55
CTIS identifier:2022-503105-38-00
A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)
Papillary Renal Cell Carcinoma
Phase 3
No
savolitinib, durvalumab, sunitinib
All
220
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm A savolitinib 600mg plus durvalumab 1500mg | Drug: savolitinib Tablets : 3 × 200 mg tablets once daily Other Name: AZD6094, HMPL-504, volitinib Drug: durvalumab Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks Other Name: MEDI4736 |
Active Comparator: Arm B sunitinib 50mg | Drug: sunitinib Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off Other Name: Sutent, SU11248 |
Experimental: Arm C durvalumab 1500mg | Drug: durvalumab Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks Other Name: MEDI4736 |