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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05043090




Registration number
NCT05043090
Ethics application status
Date submitted
11/08/2021
Date registered
13/09/2021
Date last updated
14/06/2024

Titles & IDs
Public title
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
Scientific title
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)
Secondary ID [1] 0 0
2021-000336-55
Secondary ID [2] 0 0
D5086C00001
Universal Trial Number (UTN)
Trial acronym
SAMETA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Papillary Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - savolitinib
Treatment: Drugs - durvalumab
Treatment: Drugs - sunitinib

Experimental: Arm A - savolitinib 600mg plus durvalumab 1500mg

Active comparator: Arm B - sunitinib 50mg

Experimental: Arm C - durvalumab 1500mg


Treatment: Drugs: savolitinib
Tablets : 3 × 200 mg tablets once daily

Treatment: Drugs: durvalumab
Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks

Treatment: Drugs: sunitinib
Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib
Timepoint [1] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [1] 0 0
Overall Survival (OS) /savolitinib plus durvalumab relative to sunitinib
Timepoint [1] 0 0
Approximately 28 months and approximately 42 months post first subject randomized
Secondary outcome [2] 0 0
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to sunitinib
Timepoint [2] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [3] 0 0
Duration of Response (DoR) / savolitinib plus durvalumab relative to sunitinib
Timepoint [3] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [4] 0 0
Disease Control Rate (DCR) at 24 and 48 weeks /savolitinib plus durvalumab relative to sunitinib
Timepoint [4] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [5] 0 0
Time from randomisation to second progression or death (PFS2) /savolitinib plus durvalumab relative to sunitinib
Timepoint [5] 0 0
Approximately 28 months and 42 months post first subject randomized
Secondary outcome [6] 0 0
Assessment of patient-reported symptoms, functioning, and HRQoL /savolitinib plus durvalumab relative to sunitinib
Timepoint [6] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [7] 0 0
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to durvalumab monotherapy
Timepoint [7] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [8] 0 0
Duration of Response (DoR) / savolitinib plus durvalumab relative to durvalumab monotherapy
Timepoint [8] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [9] 0 0
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to durvalumab monotherapy
Timepoint [9] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [10] 0 0
Evaluation of the PK of savolitinib pre-dose
Timepoint [10] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [11] 0 0
Evaluation of the PK of savolitinib post-dose
Timepoint [11] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [12] 0 0
Evaluation of the PK of durvalumab pre-dose
Timepoint [12] 0 0
Approximately 28 months post first subject randomized
Secondary outcome [13] 0 0
Evaluation of the PK of durvalumab / Cmax (maximum plasma concentration)
Timepoint [13] 0 0
Approximately 28 months post first subject randomized

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/09/2026
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Macquarie University
Recruitment hospital [3] 0 0
Research Site - Malvern
Recruitment hospital [4] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment outside Australia
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United States of America
State/province [1] 0 0
California
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Illinois
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Maryland
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United States of America
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Massachusetts
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New York
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Argentina
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Bahía Blanca
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Buenos Aires
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Caba
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autónoma Buenos Aires
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Argentina
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Cordoba
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La Plata
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Rosario
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San Miguel de Tucuman
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Brazil
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Belo Horizonte
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Brasilia
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Cachoeiro De Itapemirim
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Criciuma
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Curitiba
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Florianopolis
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Fortaleza
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Natal
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Salvador
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Czechia
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Ulm
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Shatin
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Cluj Napoca
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Cluj-Napoca
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Constanta
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Singapore
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Majadahonda
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Sevilla
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Valencia
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung
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Taiwan
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Tainan
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Turkey
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Adana
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Ankara
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Edirne
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Istanbul
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Izmir
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Karsiyaka
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Turkey
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Kazimkarabekir
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Ukraine
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Chernivts?
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Poltava
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Ukraine
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Zaporizhzhia
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United Kingdom
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Leicester
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT05043090
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Toni Choueiri
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05043090