Clinical trial · Interventional
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillary Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| durvalumab | Drug | Durvalumab | ALIAS |
| savolitinib | Drug | Savolitinib | ALIAS |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- savolitinib 600mg plus durvalumab 1500mg
- interventionNames
- Drug: savolitinib
- Drug: durvalumab
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- sunitinib 50mg
- interventionNames
- Drug: sunitinib
- type
- EXPERIMENTAL
- label
- Arm C
- description
- durvalumab 1500mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJackson-Spence F, Larkin J, Patel P, Valderrama BP, Rodriguez-Vida A, Glen H, Thistlethwaite FC, Ralph C, Srinivasan G, Mendez-Vidal MJ, Childress M, Li W, Boyle P, Gasco A, Markovets A, Hartmaier R, Ackerman C, Szabados BE, Priyadarshini G, Jamal F, Powles T, Suarez C. CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer. J Clin Oncol. 2026 Apr 20;44(12):1076-1082. doi: 10.1200/JCO-25-01840. Epub 2026 Mar 20. PMID 41861260