Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
SAMETA
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)
3 other identifiers
interventional
148
25 countries
139
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2021
Typical duration for phase_3
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedStudy Start
First participant enrolled
October 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMay 8, 2025
May 1, 2025
3.7 years
August 11, 2021
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib
Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants as randomised, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.
Approximately 28 months post first subject randomized
Secondary Outcomes (13)
Overall Survival (OS) /savolitinib plus durvalumab relative to sunitinib
Approximately 28 months and approximately 42 months post first subject randomized
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to sunitinib
Approximately 28 months post first subject randomized
Duration of Response (DoR) / savolitinib plus durvalumab relative to sunitinib
Approximately 28 months post first subject randomized
Disease Control Rate (DCR) at 24 and 48 weeks /savolitinib plus durvalumab relative to sunitinib
Approximately 28 months post first subject randomized
Time from randomisation to second progression or death (PFS2) /savolitinib plus durvalumab relative to sunitinib
Approximately 28 months and 42 months post first subject randomized
- +8 more secondary outcomes
Study Arms (3)
Arm A
EXPERIMENTALsavolitinib 600mg plus durvalumab 1500mg
Arm B
ACTIVE COMPARATORsunitinib 50mg
Arm C
EXPERIMENTALdurvalumab 1500mg
Interventions
Tablets : 3 × 200 mg tablets once daily
Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (139)
Research Site
Boston, Massachusetts, 02215, United States
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New York, New York, 10065, United States
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Buenos Aires, C1120AAT, Argentina
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CABA, C1426ANZ, Argentina
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Ciudad Autonoma Buenos Aires, C1181ACH, Argentina
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Ciudad Autónoma Buenos Aires, 1125, Argentina
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Córdoba, 5000, Argentina
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La Plata, 1900, Argentina
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Rosario, S2002KDS, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Box Hill, 3128, Australia
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Macquarie University, 2109, Australia
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St Leonards, 2065, Australia
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Belo Horizonte, 30120-320, Brazil
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Brasília, 70200-730, Brazil
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Cachoeiro de Itapemirim, 29308-065, Brazil
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Criciúma, 88811-508, Brazil
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Curitiba, 81520-060, Brazil
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Florianópolis, 88020-210, Brazil
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Fortaleza, 60130-241, Brazil
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Natal, 59075-740, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90110-270, Brazil
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Rio de Janeiro, 22250-905, Brazil
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Salvador, 40050-410, Brazil
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São Jose Do Rio Preto, 15090-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 05652-900, Brazil
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Săo Paulo, 01246-000, Brazil
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Vitória, 29043-260, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Providencia, 7510032, Chile
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Santiago, 7500653, Chile
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Santiago, 8420383, Chile
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Temuco, 4810561, Chile
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Beijing, 100039, China
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Changsha, 410011, China
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Changsha, 410013, China
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Chongqing, 400030, China
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Harbin, 150049, China
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Jinan, 250012, China
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Nanjing, 210029, China
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Shanghai, 200032, China
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Shenyang, 110042, China
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Tianjin, 300060, China
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Zhengzhou, 450008, China
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 775 20, Czechia
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Prague, 100 34, Czechia
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Prague, 140 59, Czechia
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Prague, 15000, Czechia
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Prague, 180 81, Czechia
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Bordeaux, 33075, France
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Quimper, 29107, France
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Toulouse, 31059, France
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Villejuif, 94800, France
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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München, 81377, Germany
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Ulm, 89081, Germany
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Hong Kong, Hong Kong
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Shatin, 00000, Hong Kong
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Bangalore, 560027, India
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Belagavi, 590010, India
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Jaipur, 302002, India
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Mysore, 570001, India
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Nashik, 422004, India
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Haifa, 91096, Israel
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Petah Tikva, 49100, Israel
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Arezzo, 52100, Italy
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Avellino, 83100, Italy
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Reggio Emilia, 42123, Italy
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Tricase, 73039, Italy
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Verona, 37134, Italy
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Aguascalientes, 20230, Mexico
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Monterrey, 64460, Mexico
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Querétaro, 76090, Mexico
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Toluca, 50090, Mexico
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Krakow, 30-348, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, Poland
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Cluj-Napoca, 400015, Romania
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Cluj-Napoca, 400641, Romania
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Craiova, 200094, Romania
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Singapore, 169610, Singapore
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Daejeon, 35015, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 405-760, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, ?08041, Spain
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Córdoba, 14004, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Kaohsiung City, 83301, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Adana, 01120, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06200, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 32098, Turkey (Türkiye)
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Istanbul, 34218, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Karşıyaka, 35575, Turkey (Türkiye)
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Kazımkarabekir, 01230, Turkey (Türkiye)
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Dnipropetrovsk, 49005, Ukraine
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Leicester, LE1 5WW, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW3 6JJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toni Choueiri
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
September 13, 2021
Study Start
October 28, 2021
Primary Completion
June 23, 2025
Study Completion
October 30, 2025
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.