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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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

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

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)

2.Event-free survival (EFS) defined as time from randomization to event in Arm 2 vs Arm 3 (Safety Run-In and Main Study)

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

NCT ID

NCT04960709

First Posted

June 17, 2021

Last Updated

August 4, 2023

Sponsor

AstraZeneca

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

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

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

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

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

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

Time Frame

Up to 84 months

Title

Time Frame

Up to 84 months

Title

Time Frame

Up to 84 months

Title

Time Frame

Up to 84 months

Title

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

Description

Clinical chemistry will be assessed by kidney function assessment in mg/dL

Time Frame

Up to 84 months

Title

Description

Clinical chemistry will be assessed by thyroid function assessment in units per mL.

Time Frame

Up to 84 months

Title

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

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

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

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

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

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

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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)

Muscle Invasive Bladder Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial