D5086C00001 - SAMETA
Research type
Research Study
Full title
A Phase III, Open Label, Randomised, 3 Arm, Multi Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) (SAMETA)
IRAS ID
294538
Contact name
Guy Faust
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-000336-55
Duration of Study in the UK
3 years, 6 months, 30 days
Research summary
The purpose of this open label, randomised, 3-arm study is to assess whether a new combination treatment (Savolitinib and Durvalumab) is better than standard treatment sunitinib in MET-driven papillary renal cell cancer (PRCC). The study will also assess the contribution of one part of the combination (Durvalumab) into the overall treatment effectiveness.
The treatments options include 1) treatment with 2 investigational drugs, savolitinib and durvalumab in combination; 2) treatment with 1 investigational drug, durvalumab, alone; and 3) treatment with sunitinib which is a standard treatment for PRCC.
Approximately 670 participants with unresectable and locally advanced or metastatic PRCC will be screened to achieve approximately 200 participants randomly assigned to study intervention.
The 200 participants will be randomised, at approximately 165 centres in 25 countries, in a 2:1:1 ratio to receive treatment with 600 mg savolitinib once daily plus 1500 mg durvalumab every 4 weeks (Arm A), sunitinib 50 mg once daily (Arm B), or 1500 mg durvalumab every 4 weeks (Arm C). Participants can continue to receive study treatments as long as they are still receiving benefits from them. Participants will be followed up when they stop study treatment every 3 months.
Effective therapies for PRCC represent an unmet medical need. Papillary RCC is the most common subtype of non-clear cell renal cell carcinoma (nccRCC), accounting for 10% to 15% of renal malignancies. Available therapies have all been approved for the broader condition, RCC, with limited efficacy data obtained in PRCC. In practice, treatment of PRCC is based on extrapolation of data from studies conducted almost exclusively in ccRCC and international guidelines recommend a clinical study as one of the preferred options for treatment of advanced/metastatic PRCC patients. These facts indicate that novel therapies are urgently needed to improve clinical outcomes in these patients.
AstraZeneca is funding this research.
REC name
Wales REC 2
REC reference
21/WA/0195
Date of REC Opinion
17 Aug 2021
REC opinion
Further Information Favourable Opinion