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A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Primary Purpose

Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Radical cystectomy (RC)

Bempegaldesleukin

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring immunotherapy, NKTR-214, nivolumab, bempeg

Eligibility Criteria

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

Inclusion Criteria:

Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Cisplatin-ineligible participants will be defined by any one of the following criteria:
i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing loss (assessed per local SOC).

iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy.

Documented Left Ventricular Ejection Fraction (LVEF) more than 45%

Exclusion Criteria:

Clinical evidence of ≥ N2 or metastatic bladder cancer
Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment.
Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC
History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event
Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias)

Other protocol-defined inclusion/exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Arm A: Combination Therapy

Arm B: Monotherapy

Arm C: Standard-of-care

Arm Description

Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg

Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab

RC alone, without neoadjuvant or adjuvant therapy

Outcomes

Primary Outcome Measures

Pathologic Complete Response (pCR) rate of Arm A to Arm C

Event-Free Survival (EFS) of Arm A vs Arm C

Secondary Outcome Measures

pCR rate of Arm B to Arm C

EFS of Arm B vs Arm C

Overall Survival (OS)

Incidence of Adverse Events (AEs)

Incidence of Serious Adverse Events (SAEs)

Incidence of AEs leading to discontinuation

Incidence of immune-mediated AEs (imAEs)

Incidence of participants with clinical laboratory abnormalities

pCR rate of Arm A to Arm B

EFS of Arm A vs Arm B

Full Information

NCT ID

NCT04209114

First Posted

December 20, 2019

Last Updated

October 11, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Nektar Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04209114

Brief Title

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Official Title

A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

February 5, 2020 (Actual)

Primary Completion Date

June 7, 2023 (Actual)

Study Completion Date

June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Nektar Therapeutics

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

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer

Keywords

immunotherapy, NKTR-214, nivolumab, bempeg

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Combination Therapy

Arm Type

Experimental

Arm Description

Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg

Arm Title

Arm B: Monotherapy

Arm Type

Experimental

Arm Description

Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab

Arm Title

Arm C: Standard-of-care

Arm Type

Other

Arm Description

RC alone, without neoadjuvant or adjuvant therapy

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, BMS-936558

Intervention Description

Specified dose on specified days

Intervention Type

Procedure

Intervention Name(s)

Radical cystectomy (RC)

Intervention Description

Surgical removal of the bladder

Intervention Type

Biological

Intervention Name(s)

Bempegaldesleukin

Other Intervention Name(s)

BMS-986321, NKTR-214, Bempeg

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Pathologic Complete Response (pCR) rate of Arm A to Arm C

Time Frame

Approximately 43 months

Title

Event-Free Survival (EFS) of Arm A vs Arm C

Time Frame

Approximately 43 months

Secondary Outcome Measure Information:

Title

pCR rate of Arm B to Arm C

Time Frame

Approximately 43 months

Title

EFS of Arm B vs Arm C

Time Frame

Approximately 43 months

Title

Overall Survival (OS)

Time Frame

Approximately 43 months

Title

Incidence of Adverse Events (AEs)

Time Frame

Up to 76.5 weeks

Title

Incidence of Serious Adverse Events (SAEs)

Time Frame

Up to 76.5 weeks

Title

Incidence of AEs leading to discontinuation

Time Frame

Up to 76.5 weeks

Title

Incidence of immune-mediated AEs (imAEs)

Time Frame

Up to 76.5 weeks

Title

Incidence of participants with clinical laboratory abnormalities

Time Frame

Up to 76.5 weeks

Title

pCR rate of Arm A to Arm B

Time Frame

Approximately 43 months

Title

EFS of Arm A vs Arm B

Time Frame

Approximately 43 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT) Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Cisplatin-ineligible participants will be defined by any one of the following criteria: i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing loss (assessed per local SOC). iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy. Documented Left Ventricular Ejection Fraction (LVEF) more than 45% Exclusion Criteria: Clinical evidence of ≥ N2 or metastatic bladder cancer Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment. Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias) Other protocol-defined inclusion/exclusion criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0080

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Local Institution - 0136

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Local Institution - 0029

City

La Jolla

State/Province

California

ZIP/Postal Code

92092-0698

Country

United States

Facility Name

Local Institution - 0015

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Local Institution - 0002

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Local Institution

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Local Institution - 0006

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Local Institution - 0009

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Local Institution - 0004

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Local Institution - 0005

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Local Institution - 0007

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Local Institution - 0139

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0023

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Local Institution - 0122

City

Gig Harbor

State/Province

Washington

ZIP/Postal Code

98332

Country

United States

Facility Name

Local Institution - 0102

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 0096

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1419

Country

Argentina

Facility Name

Local Institution - 0028

City

Ciudad Autónoma De Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution - 0124

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Local Institution - 0027

City

Capital Federal

State/Province

Distrito Federal

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution - 0174

City

Rosario

State/Province

Santa FE

ZIP/Postal Code

S2000DTC

Country

Argentina

Facility Name

Local Institution - 0097

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution - 0137

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

Local Institution - 0158

City

Ballarat

State/Province

Victoria

ZIP/Postal Code

3350

Country

Australia

Facility Name

Local Institution - 0157

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Local Institution - 0011

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution - 0013

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Local Institution - 0148

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Local Institution - 0150

City

Vienna

ZIP/Postal Code

1160

Country

Austria

Facility Name

Local Institution - 0123

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution - 0083

City

Wilrijk

State/Province

Antwerpen

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Local Institution - 0101

City

Brussel

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Local Institution - 0098

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Local Institution - 0068

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution - 0100

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Local Institution - 0177

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90560-030

Country

Brazil

Facility Name

Local Institution - 0039

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Local Institution - 0176

City

Barretos

State/Province

SAO Paulo

ZIP/Postal Code

14784400

Country

Brazil

Facility Name

Local Institution - 0037

City

Jau

State/Province

Sao Paulo

ZIP/Postal Code

17210-120

Country

Brazil

Facility Name

Local Institution - 0038

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01509-010

Country

Brazil

Facility Name

Local Institution - 0041

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Local Institution - 0040

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Local Institution - 0082

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Local Institution - 0036

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

JiH 5N4

Country

Canada

Facility Name

Local Institution - 0018

City

Quebec

ZIP/Postal Code

G1R3S1

Country

Canada

Facility Name

Local Institution - 0204

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400016

Country

China

Facility Name

Local Institution

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

Facility Name

Local Institution

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450000

Country

China

Facility Name

Local Institution

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

Local Institution

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410031

Country

China

Facility Name

Local Institution

City

Taiyuan

State/Province

Shan1xi

Country

China

Facility Name

Local Institution

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250117

Country

China

Facility Name

Local Institution - 0022

City

Olomouc

ZIP/Postal Code

77900

Country

Czechia

Facility Name

Local Institution - 0020

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Local Institution - 0021

City

Praha

ZIP/Postal Code

14059

Country

Czechia

Facility Name

Local Institution - 0077

City

Avignon Cedex 9

ZIP/Postal Code

84918

Country

France

Facility Name

Local Institution - 0091

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution - 0151

City

Clermont-Ferrand

ZIP/Postal Code

63011

Country

France

Facility Name

Local Institution - 0059

City

La Roche-sur-Yon

ZIP/Postal Code

85000

Country

France

Facility Name

Local Institution - 0071

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

Local Institution - 0057

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Local Institution - 0075

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

Local Institution - 0070

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

Local Institution - 0062

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Local Institution - 0060

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

Local Institution - 0064

City

Quimper

ZIP/Postal Code

29000

Country

France

Facility Name

Local Institution - 0161

City

Reims

ZIP/Postal Code

51726

Country

France

Facility Name

Local Institution - 0058

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Name

Local Institution - 0056

City

Suresnes

ZIP/Postal Code

92151

Country

France

Facility Name

Local Institution - 0074

City

Tours

ZIP/Postal Code

37000

Country

France

Facility Name

Universitatsklinikum Carl Gustav Carus

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution - 0117

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Local Institution - 0119

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Local Institution - 0050

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Local Institution - 0052

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Local Institution - 0051

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Local Institution - 0049

City

Herne

ZIP/Postal Code

44625

Country

Germany

Facility Name

Local Institution - 0045

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Local Institution - 0053

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Local Institution - 0113

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Local Institution - 0048

City

Nuernberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Local Institution - 0046

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Local Institution - 0178

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Local Institution - 0088

City

Athens

ZIP/Postal Code

15125

Country

Greece

Facility Name

Local Institution - 0033

City

Chaidari

ZIP/Postal Code

12462

Country

Greece

Facility Name

Local Institution - 0035

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Local Institution - 0129

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution - 0131

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Local Institution - 0130

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution - 0149

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Local Institution - 0162

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Local Institution - 0025

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution - 0026

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Local Institution - 0065

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution - 0044

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Local Institution - 0154

City

La Paz

State/Province

BAJA Californa SUR

ZIP/Postal Code

23040

Country

Mexico

Facility Name

Local Institution - 0132

City

Ciudad de Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Local Institution - 0160

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Local Institution - 0133

City

Monterrey

State/Province

Nuevo LEON

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution - 0069

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 0167

City

Biala Podlaska

ZIP/Postal Code

21-505

Country

Poland

Facility Name

Local Institution - 0054

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Local Institution - 0104

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Local Institution - 0106

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Local Institution - 0110

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0109

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Local Institution - 0105

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution - 0108

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 0103

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0107

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Local Institution - 0111

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution

City

Stevenage

State/Province

Hertfordshire

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Local Institution - 0085

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Local Institution - 0042

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

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A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Bladder Cancer, Bladder Tumor, 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

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