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Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin (VOLGA)

Primary Purpose

Muscle Invasive Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Tremelimumab
Enfortumab Vedotin
Radical Cystectomy
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Invasive Bladder Cancer focused on measuring Bladder Cancer, Immunotherapy, PD-L1, Durvalumab (MEDI4736), Tremelimumab, Enfortumab Vedotin (PADCEV)

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically documented muscle-invasive UC of the bladder.
  • Participants with transitional cell and mixed transitional/non-transitional cell histologies;
  • Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0.
  • Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
  • Medically fit for cystectomy and able to receive neoadjuvant therapy;
  • Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
  • ECOG performance status of 0,1,2 at enrollment.
  • Availability of tumor sample prior to study entry;
  • Must have a life expectancy of at least 12 weeks at randomization.
  • Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy (must be documented in the medical records)

Exclusion criteria:

  • Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
  • Active infection
  • Uncontrolled intercurrent illness
  • Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Durvalumab + Tremelimumab + Enfortumab vedotin

Durvalumab + Enfortumab vedotin

Cystectomy with or without approved Adjuvant Therapy.

Arm Description

Participants will receive 3 preoperative 21-day cycles of Durvalumab + Tremelimumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days.

Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days.

Participants may receive SoC (nivolumab approved as adjuvant treatment for MIBC based on high risk criteria) per approved label in the country OR Participants receive standard of care surgery (radical cystectomy) alone.

Outcomes

Primary Outcome Measures

Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on pCR rate (Safety Run-In and Main Study)
Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per central pathological review using specimens obtained via cystectomy, up to 3 years.
Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on EFS (Safety Run-In and Main Study)
Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 3 years.
Safety and Tolerability as evaluated by adverse events occurring throughout the study (Safety Run-In part)
Frequency of Adverse Events.
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (blood pressure in mmHg) (Safety Run-In part)
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (pulse rate) in beats per minute (Safety Run-In part)
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (respiration rate) in breaths per minute (Safety Run-In part)
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (temperature) in degrees Celsius (Safety Run-In part)
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin s assessed by abnormality in clinical chemistry by liver function (Safety Run-In part)
Clinical chemistry will be assessed by liver function assessment (ALT, AST, albumin, total bilirubin measured in units per dL)
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by kidney function (Safety Run-In part)
Clinical chemistry will be assessed by kidney function assessment in mg/dL
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by thyroid function (Safety Run-In part)
Clinical chemistry will be assessed by thyroid function assessment in units per mL.
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in haematology (Safety Run-In part)
Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by ECG (pulse rate) (Safety Run-In part)
Changes in WHO/ECOG performance status (Safety Run-In part)
Eastern Cooperative Oncology Group (ECOG) performance status scale range 0 to 5, where 0 is fully active, able to carry on all pre disease performance without restriction - best outcome and 5 -death - worst outcome.

Secondary Outcome Measures

1.Pathologic complete response (pCR) rates at time of cystectomy in Arm 2 vs Arm 3 (Safety Run-In and Main Study)
Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per central pathological review using specimens obtained via cystectomy, at 3 years.
2.Event-free survival (EFS) defined as time from randomization to event in Arm 2 vs Arm 3 (Safety Run-In and Main Study)
Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 5 years.
3.Overall survival (Main Study part)
Overall Survival is defined as length of time from randomization until the date of death due to any cause, whichever came first, assessed up to 5 years.
4.EFS at 24 months (EFS24) (Main Study part)
EFS24 is defined as proportion of participants alive and event-free at 24 months
5.Overall survival rate at 5 years (Main Study part)
The proportion of participants alive at 5 years (OS5) is defined as the Kaplan-Meier estimate of OS at 5 years after randomization
6.Disease-free survival (DFS) (Main Study part)
DFS is defined as time from radical cystectomy to recurrence or death, whichever came first, assessed up to 5 years.
7.Pathologic downstaging (pDS) rate-to < pT2 (Main Study part)
pDS rate is defined as the rate of downstaging to < pT2, including pT0, pTis, pTa, pT1, and N0
8.Disease-specific survival (DSS) (Main Study part)
DSS is defined as time from randomization until death due to bladder cancer, assessed up to 5 years.
9.EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire) (Main Study part)
10.Immunogenicity of durvalumab when used in combination with Tremelimumab as measured by presence of antidrug antibodies (ADA) (Main Study part)
11.Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab and tremelimumab (Main Study part)
11.Time to maximum observed serum concentration (tmax) of durvalumab and tremelimumab (Main Study part)
12. Metastasis-free survival (MFS) (Main Study part)
MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first, up to approximately 48 months.

Full Information

First Posted
June 17, 2021
Last Updated
August 4, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04960709
Brief Title
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Acronym
VOLGA
Official Title
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
July 18, 2025 (Anticipated)
Study Completion Date
September 8, 2028 (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 global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer. The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC). Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Invasive Bladder Cancer
Keywords
Bladder Cancer, Immunotherapy, PD-L1, Durvalumab (MEDI4736), Tremelimumab, Enfortumab Vedotin (PADCEV)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
None (Open Label)
Allocation
Randomized
Enrollment
830 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab + Tremelimumab + Enfortumab vedotin
Arm Type
Experimental
Arm Description
Participants will receive 3 preoperative 21-day cycles of Durvalumab + Tremelimumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days.
Arm Title
Durvalumab + Enfortumab vedotin
Arm Type
Experimental
Arm Description
Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days.
Arm Title
Cystectomy with or without approved Adjuvant Therapy.
Arm Type
Active Comparator
Arm Description
Participants may receive SoC (nivolumab approved as adjuvant treatment for MIBC based on high risk criteria) per approved label in the country OR Participants receive standard of care surgery (radical cystectomy) alone.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
IMFINZI, MEDI4736
Intervention Description
Anti- PD-L1 Antibody
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Intervention Description
Human IgG2 mAb
Intervention Type
Drug
Intervention Name(s)
Enfortumab Vedotin
Other Intervention Name(s)
PADCEV
Intervention Description
Nectin-4-directed antibody and microtubule inhibitor conjugate
Intervention Type
Procedure
Intervention Name(s)
Radical Cystectomy
Intervention Description
For cisplatin-ineligible or cisplatin-refusal patients
Primary Outcome Measure Information:
Title
Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on pCR rate (Safety Run-In and Main Study)
Description
Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per central pathological review using specimens obtained via cystectomy, up to 3 years.
Time Frame
Up to 3 years
Title
Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on EFS (Safety Run-In and Main Study)
Description
Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 3 years.
Time Frame
Up to 3 years
Title
Safety and Tolerability as evaluated by adverse events occurring throughout the study (Safety Run-In part)
Description
Frequency of Adverse Events.
Time Frame
At completion of study treatment by the last patient and at 3 months.
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (blood pressure in mmHg) (Safety Run-In part)
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (pulse rate) in beats per minute (Safety Run-In part)
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (respiration rate) in breaths per minute (Safety Run-In part)
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by vital signs (temperature) in degrees Celsius (Safety Run-In part)
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin s assessed by abnormality in clinical chemistry by liver function (Safety Run-In part)
Description
Clinical chemistry will be assessed by liver function assessment (ALT, AST, albumin, total bilirubin measured in units per dL)
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by kidney function (Safety Run-In part)
Description
Clinical chemistry will be assessed by kidney function assessment in mg/dL
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by thyroid function (Safety Run-In part)
Description
Clinical chemistry will be assessed by thyroid function assessment in units per mL.
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in haematology (Safety Run-In part)
Description
Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Time Frame
Up to 84 months
Title
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by ECG (pulse rate) (Safety Run-In part)
Time Frame
Up to 84 months
Title
Changes in WHO/ECOG performance status (Safety Run-In part)
Description
Eastern Cooperative Oncology Group (ECOG) performance status scale range 0 to 5, where 0 is fully active, able to carry on all pre disease performance without restriction - best outcome and 5 -death - worst outcome.
Time Frame
Up to 84 months
Secondary Outcome Measure Information:
Title
1.Pathologic complete response (pCR) rates at time of cystectomy in Arm 2 vs Arm 3 (Safety Run-In and Main Study)
Description
Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per central pathological review using specimens obtained via cystectomy, at 3 years.
Time Frame
3 years
Title
2.Event-free survival (EFS) defined as time from randomization to event in Arm 2 vs Arm 3 (Safety Run-In and Main Study)
Description
Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 5 years.
Time Frame
Up to 5 years
Title
3.Overall survival (Main Study part)
Description
Overall Survival is defined as length of time from randomization until the date of death due to any cause, whichever came first, assessed up to 5 years.
Time Frame
Up to 5 years
Title
4.EFS at 24 months (EFS24) (Main Study part)
Description
EFS24 is defined as proportion of participants alive and event-free at 24 months
Time Frame
Up to 24 months
Title
5.Overall survival rate at 5 years (Main Study part)
Description
The proportion of participants alive at 5 years (OS5) is defined as the Kaplan-Meier estimate of OS at 5 years after randomization
Time Frame
At 5 years
Title
6.Disease-free survival (DFS) (Main Study part)
Description
DFS is defined as time from radical cystectomy to recurrence or death, whichever came first, assessed up to 5 years.
Time Frame
Up to first recurrence of disease or death up to 5 years
Title
7.Pathologic downstaging (pDS) rate-to < pT2 (Main Study part)
Description
pDS rate is defined as the rate of downstaging to < pT2, including pT0, pTis, pTa, pT1, and N0
Time Frame
3 years
Title
8.Disease-specific survival (DSS) (Main Study part)
Description
DSS is defined as time from randomization until death due to bladder cancer, assessed up to 5 years.
Time Frame
from randomization until death due to bladder cancer up to 5 year.
Title
9.EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire) (Main Study part)
Time Frame
from baseline and time to definitive clinically, assessed up to 5 years
Title
10.Immunogenicity of durvalumab when used in combination with Tremelimumab as measured by presence of antidrug antibodies (ADA) (Main Study part)
Time Frame
At 3 months after last dose of durvalumab and tremelimumab
Title
11.Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab and tremelimumab (Main Study part)
Time Frame
At 3 months after last dose of durvalumab and tremelimumab
Title
11.Time to maximum observed serum concentration (tmax) of durvalumab and tremelimumab (Main Study part)
Time Frame
At 3 months after last dose of durvalumab and tremelimumab
Title
12. Metastasis-free survival (MFS) (Main Study part)
Description
MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first, up to approximately 48 months.
Time Frame
From randomization until the first recognition of distant metastases or death, up to approximately 48 months.

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 or cytologically documented muscle-invasive UC of the bladder. Participants with transitional cell and mixed transitional/non-transitional cell histologies; Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0. Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC. Medically fit for cystectomy and able to receive neoadjuvant therapy; Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC; ECOG performance status of 0,1,2 at enrollment. Availability of tumor sample prior to study entry; Must have a life expectancy of at least 12 weeks at randomization. Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy (must be documented in the medical records) Exclusion criteria: Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening. Active infection Uncontrolled intercurrent illness Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies. Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.
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
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berazategui
ZIP/Postal Code
B1884BBF
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1280AEB
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
C1430EFA
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1419AHL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pilar
ZIP/Postal Code
B1629AHJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krems
ZIP/Postal Code
3500
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
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
Fortaleza
ZIP/Postal Code
60135-237
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350200
Country
Brazil
Individual Site Status
Not yet 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
Santa Maria
ZIP/Postal Code
97015-450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Săo Paulo
ZIP/Postal Code
03162-065
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Uberlândia
ZIP/Postal Code
38408-150
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
Not yet recruiting
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Not yet 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
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
80001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cali
ZIP/Postal Code
760043
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
050010
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Medellín
Country
Colombia
Individual Site Status
Suspended
Facility Name
Research Site
City
Amiens
ZIP/Postal Code
80090
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marseille CEDEX
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint-Priez En Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30559
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
Herne
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Reutlingen
ZIP/Postal Code
72766
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Maroussi, Athens
ZIP/Postal Code
15125
Country
Greece
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
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9112001
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
Aviano
ZIP/Postal Code
33081
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
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
Pozzuoli
ZIP/Postal Code
80078
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00137
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Terni
ZIP/Postal Code
05100
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
37124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamamatsu-shi
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hirosaki-shi
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ichikawa-shi
ZIP/Postal Code
272-8516
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashihara-shi
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kumamoto-shi
ZIP/Postal Code
860-0008
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Matsuyama-shi
ZIP/Postal Code
791-0288
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miyazaki-shi
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toyama-shi
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsukuba-shi
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Busan
ZIP/Postal Code
47392
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
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02841
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
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Colima
ZIP/Postal Code
28018
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64570
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tlalpan
ZIP/Postal Code
14050
Country
Mexico
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
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hilversum
ZIP/Postal Code
1313 XZ
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nowa Sol
ZIP/Postal Code
67-106
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Braga
ZIP/Postal Code
4710
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1500-458
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisbon
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Nizhniy Novgorod
ZIP/Postal Code
603074
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630007
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
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
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
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28033
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
28046
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
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
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
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dusit
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
5000
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Antalya
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
34722
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
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kiev
ZIP/Postal Code
3022
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G12 0XH
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
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh city
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hue
ZIP/Postal Code
530000
Country
Vietnam
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.
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 de-identified 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

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin

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