Back to resultsSavolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC (SAMETA)
Primary Purpose
Papillary Renal Cell Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
savolitinib
durvalumab
sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Papillary Renal Cell Carcinoma focused on measuring Locally, Advanced, Metastatic, Carcinoma, Savolitinib, Sunitinib, Durvalumab, MET Driven, Papillary Renal Cell Carcinoma, Renal Cell
Eligibility Criteria
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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Arm A
Arm B
Arm C
Arm Description
savolitinib 600mg plus durvalumab 1500mg
sunitinib 50mg
durvalumab 1500mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival (OS) /savolitinib plus durvalumab relative to sunitinib
Defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants as randomised regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy.
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to sunitinib
Defined as the proportion of participants who have a Complete Response (CR) or Partial Response (PR) as determined by BICR per RECIST 1.1.
Duration of Response (DoR) / savolitinib plus durvalumab relative to sunitinib
Defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Disease Control Rate (DCR) at 24 and 48 weeks /savolitinib plus durvalumab relative to sunitinib
Defined as the percentage of participants who have a CR or PR or who have Stable Disease (SD) per RECIST 1.1 as assessed by BICR for at least 23 or 47 weeks, respectively after randomisation.
Time from randomisation to second progression or death (PFS2) /savolitinib plus durvalumab relative to sunitinib
Defined as time from randomisation to the earliest of the progression event (following the initial progression), subsequent to the first subsequent therapy or death.
Assessment of patient-reported symptoms, functioning, and HRQoL /savolitinib plus durvalumab relative to sunitinib
Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by FKSI-19.
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to durvalumab monotherapy
Defined as the proportion of participants who have a Complete Response (CR) or Partial Response (PR) as determined by BICR per RECIST 1.1
Duration of Response (DoR) / savolitinib plus durvalumab relative to durvalumab monotherapy
Defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to durvalumab monotherapy
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.
Evaluation of the PK of savolitinib pre-dose
Plasma concentration of savolitinib and its metabolites pre-dose (Ctrough / trough plasma concentration : measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) in participants randomised to savolitinib plus durvalumab.
Evaluation of the PK of savolitinib post-dose
Plasma concentration of savolitinib and its metabolites post-dose (C1h and C3h) in participants randomised to savolitinib plus durvalumab.
Evaluation of the PK of durvalumab pre-dose
Serum concentration of durvalumab pre-dose (Ctrough / trough plasma concentration : measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) in participants randomised to savolitinib plus durvalumab or durvalumab monotherapy.
Evaluation of the PK of durvalumab / Cmax (maximum plasma concentration)
Serum concentration of durvalumab at the end of infusion (Cmax) in participants randomised to savolitinib plus durvalumab or durvalumab monotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05043090
Brief Title
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
Acronym
SAMETA
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
September 14, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
Detailed Description
This is a Phase III, randomised, open label, 3 arm, multi-centre, international study assessing the efficacy and safety of savolitinib plus durvalumab compared with sunitinib in participants with MET-driven (without co-occurring FH mutations), unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anti-cancer therapy in the metastatic setting. The study will also investigate the contribution of durvalumab to the savolitinib plus durvalumab combination.
Approximately 200 participants will be randomised in a 2:1:1 ratio to one of the following intervention groups: savolitinib (600mg, oral, once daily) plus durvalumab (1500mg IV Q4W), sunitinib (50mg, oral, once daily for 4 consecutive weeks, followed by a sunitinib-free interval of 2-weeks, Q6W), or durvalumab monotherapy (1500mg IV Q4W).
Participants will continue to receive study intervention until objective radiological PD per RECIST 1.1 is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.
Depending on the preferred subsequent therapy, participants randomised to the durvalumab monotherapy arm will be eligible to switch to receive savolitinib in combination with durvalumab at the time of objective radiological PD assessed by BICR per RECIST 1.1, without any intervening systemic anti-cancer therapy following discontinuation of durvalumab monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Renal Cell Carcinoma
Keywords
Locally, Advanced, Metastatic, Carcinoma, Savolitinib, Sunitinib, Durvalumab, MET Driven, Papillary Renal Cell Carcinoma, Renal Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
savolitinib 600mg plus durvalumab 1500mg
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
sunitinib 50mg
Arm Title
Arm C
Arm Type
Experimental
Arm Description
durvalumab 1500mg
Intervention Type
Drug
Intervention Name(s)
savolitinib
Other Intervention Name(s)
AZD6094, HMPL-504, volitinib
Intervention Description
Tablets : 3 × 200 mg tablets once daily
Intervention Type
Drug
Intervention Name(s)
durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
Intervention Type
Drug
Intervention Name(s)
sunitinib
Other Intervention Name(s)
Sutent, SU11248
Intervention Description
Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib
Description
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.
Time Frame
Approximately 28 months post first subject randomized
Secondary Outcome Measure Information:
Title
Overall Survival (OS) /savolitinib plus durvalumab relative to sunitinib
Description
Defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants as randomised regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy.
Time Frame
Approximately 28 months and approximately 42 months post first subject randomized
Title
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to sunitinib
Description
Defined as the proportion of participants who have a Complete Response (CR) or Partial Response (PR) as determined by BICR per RECIST 1.1.
Time Frame
Approximately 28 months post first subject randomized
Title
Duration of Response (DoR) / savolitinib plus durvalumab relative to sunitinib
Description
Defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Time Frame
Approximately 28 months post first subject randomized
Title
Disease Control Rate (DCR) at 24 and 48 weeks /savolitinib plus durvalumab relative to sunitinib
Description
Defined as the percentage of participants who have a CR or PR or who have Stable Disease (SD) per RECIST 1.1 as assessed by BICR for at least 23 or 47 weeks, respectively after randomisation.
Time Frame
Approximately 28 months post first subject randomized
Title
Time from randomisation to second progression or death (PFS2) /savolitinib plus durvalumab relative to sunitinib
Description
Defined as time from randomisation to the earliest of the progression event (following the initial progression), subsequent to the first subsequent therapy or death.
Time Frame
Approximately 28 months and 42 months post first subject randomized
Title
Assessment of patient-reported symptoms, functioning, and HRQoL /savolitinib plus durvalumab relative to sunitinib
Description
Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by FKSI-19.
Time Frame
Approximately 28 months post first subject randomized
Title
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to durvalumab monotherapy
Description
Defined as the proportion of participants who have a Complete Response (CR) or Partial Response (PR) as determined by BICR per RECIST 1.1
Time Frame
Approximately 28 months post first subject randomized
Title
Duration of Response (DoR) / savolitinib plus durvalumab relative to durvalumab monotherapy
Description
Defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Time Frame
Approximately 28 months post first subject randomized
Title
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to durvalumab monotherapy
Description
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.
Time Frame
Approximately 28 months post first subject randomized
Title
Evaluation of the PK of savolitinib pre-dose
Description
Plasma concentration of savolitinib and its metabolites pre-dose (Ctrough / trough plasma concentration : measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) in participants randomised to savolitinib plus durvalumab.
Time Frame
Approximately 28 months post first subject randomized
Title
Evaluation of the PK of savolitinib post-dose
Description
Plasma concentration of savolitinib and its metabolites post-dose (C1h and C3h) in participants randomised to savolitinib plus durvalumab.
Time Frame
Approximately 28 months post first subject randomized
Title
Evaluation of the PK of durvalumab pre-dose
Description
Serum concentration of durvalumab pre-dose (Ctrough / trough plasma concentration : measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) in participants randomised to savolitinib plus durvalumab or durvalumab monotherapy.
Time Frame
Approximately 28 months post first subject randomized
Title
Evaluation of the PK of durvalumab / Cmax (maximum plasma concentration)
Description
Serum concentration of durvalumab at the end of infusion (Cmax) in participants randomised to savolitinib plus durvalumab or durvalumab monotherapy.
Time Frame
Approximately 28 months post first subject randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni Choueiri
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bahía Blanca
ZIP/Postal Code
8000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ciudad Autónoma Buenos Aires
ZIP/Postal Code
1125
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Macquarie University
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30120-320
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cachoeiro De Itapemirim
ZIP/Postal Code
29308-065
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Criciuma
ZIP/Postal Code
88811-508
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Florianopolis
ZIP/Postal Code
88020-210
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60130-241
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pelotas
ZIP/Postal Code
96020-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Săo Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vitoria
ZIP/Postal Code
29043-260
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Providencia
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
4810561
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150049
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31052
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shatin
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560027
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belagavi
ZIP/Postal Code
590010
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kochi
ZIP/Postal Code
682026
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700020
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mysore
ZIP/Postal Code
570001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422004
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
91096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Safed
ZIP/Postal Code
13100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tricase
ZIP/Postal Code
73039
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cancún
ZIP/Postal Code
77500
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
México
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toluca De Lerdo
ZIP/Postal Code
50090
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-848
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baia Mare
ZIP/Postal Code
430295
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200094
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Kursk
ZIP/Postal Code
305524
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Kuzmolovskiy
ZIP/Postal Code
188663
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
St-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Research Site
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
?08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
32098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34218
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Karsiyaka
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kazımkarabekir
ZIP/Postal Code
01230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chernivtsі
ZIP/Postal Code
58001
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69040
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
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