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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

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
2022-503105-38-00
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
Active, not 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
12/06/2026
Actual
Sample size
Target
Accrual to date
Final
147
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 - 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
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
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Argentina
State/province [4] 0 0
Caba
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad Autonoma Buenos Aires
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Argentina
State/province [6] 0 0
Ciudad Autónoma Buenos Aires
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Argentina
State/province [7] 0 0
Cordoba
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Argentina
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La Plata
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Argentina
State/province [10] 0 0
San Miguel de Tucuman
Country [11] 0 0
Brazil
State/province [11] 0 0
Belo Horizonte
Country [12] 0 0
Brazil
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Brasilia
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Brazil
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Cachoeiro De Itapemirim
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Brazil
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Criciuma
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Brazil
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Curitiba
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Brazil
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Florianopolis
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Brazil
State/province [17] 0 0
Fortaleza
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Brazil
State/province [18] 0 0
Natal
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Brazil
State/province [19] 0 0
Pelotas
Country [20] 0 0
Brazil
State/province [20] 0 0
Porto Alegre
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio de Janeiro
Country [22] 0 0
Brazil
State/province [22] 0 0
Salvador
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Brazil
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Sao Paulo
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Brazil
State/province [24] 0 0
São Jose do Rio Preto
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Brazil
State/province [25] 0 0
Vitoria
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Chile
State/province [28] 0 0
Providencia
Country [29] 0 0
Chile
State/province [29] 0 0
Santiago
Country [30] 0 0
Chile
State/province [30] 0 0
Temuco
Country [31] 0 0
China
State/province [31] 0 0
Beijing
Country [32] 0 0
China
State/province [32] 0 0
Changsha
Country [33] 0 0
China
State/province [33] 0 0
Chongqing
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China
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Harbin
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China
State/province [35] 0 0
Jinan
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China
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Nanjing
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China
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Shanghai
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China
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Shenyang
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China
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Tianjin
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China
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Zhengzhou
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Praha 10
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Czechia
State/province [45] 0 0
Praha 5
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Czechia
State/province [46] 0 0
Praha 8
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Czechia
State/province [47] 0 0
Praha
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France
State/province [48] 0 0
Bordeaux
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France
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Quimper
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France
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Toulouse Cedex 9
Country [51] 0 0
France
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Villejuif
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Germany
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Hamburg
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Germany
State/province [53] 0 0
Hannover
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Germany
State/province [54] 0 0
München
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Germany
State/province [55] 0 0
Ulm
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Hong Kong
State/province [56] 0 0
Hong Kong
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Hong Kong
State/province [57] 0 0
Shatin
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India
State/province [58] 0 0
Bangalore
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India
State/province [59] 0 0
Belagavi
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India
State/province [60] 0 0
Jaipur
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India
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Mysore
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India
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Nashik
Country [63] 0 0
Israel
State/province [63] 0 0
Haifa
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Israel
State/province [64] 0 0
Petah Tikva
Country [65] 0 0
Italy
State/province [65] 0 0
Arezzo
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Italy
State/province [66] 0 0
Avellino
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Italy
State/province [67] 0 0
Bari
Country [68] 0 0
Italy
State/province [68] 0 0
Bologna
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Italy
State/province [69] 0 0
Firenze
Country [70] 0 0
Italy
State/province [70] 0 0
Meldola
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Reggio Emilia
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Italy
State/province [75] 0 0
Tricase
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Italy
State/province [76] 0 0
Verona
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Korea, Republic of
State/province [77] 0 0
Daejeon
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Goyang-si
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Korea, Republic of
State/province [79] 0 0
Incheon
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Korea, Republic of
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Seoul
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Mexico
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Aguascalientes
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Mexico
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Monterrey
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Mexico
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Queretaro
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Mexico
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Toluca De Lerdo
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Netherlands
State/province [85] 0 0
Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Rotterdam
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Kraków
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Poland
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Otwock
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Poland
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Poznan
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Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Coruña
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
State/province [102] 0 0
Málaga
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Spain
State/province [103] 0 0
Pamplona
Country [104] 0 0
Spain
State/province [104] 0 0
Sevilla
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Spain
State/province [105] 0 0
Valencia
Country [106] 0 0
Taiwan
State/province [106] 0 0
Kaohsiung City
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taichung
Country [108] 0 0
Taiwan
State/province [108] 0 0
Tainan
Country [109] 0 0
Turkey
State/province [109] 0 0
Adana
Country [110] 0 0
Turkey
State/province [110] 0 0
Ankara
Country [111] 0 0
Turkey
State/province [111] 0 0
Edirne
Country [112] 0 0
Turkey
State/province [112] 0 0
Istanbul
Country [113] 0 0
Turkey
State/province [113] 0 0
Izmir
Country [114] 0 0
Turkey
State/province [114] 0 0
Karsiyaka
Country [115] 0 0
Turkey
State/province [115] 0 0
Kazimkarabekir
Country [116] 0 0
Ukraine
State/province [116] 0 0
Dnipropetrovsk
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Leicester
Country [118] 0 0
United Kingdom
State/province [118] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05043090