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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

  • Clinicaltrials.gov identifier

    NCT04209114

  • Recruitment Status

    Recruiting

  • First Posted

    December 23, 2019

  • Last update posted

    March 21, 2022

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.

  • Condition or Disease:Bladder Cancer
    Bladder Tumor
    Muscle-Invasive Bladder Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Bempegaldesleukin
    Procedure: Radical cystectomy (RC)
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 540 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official 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
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: December 2026
  • Estimated Study Completion Date: June 2029

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Combination Therapy
Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg
Biological: Nivolumab
Specified dose on specified days

Biological: Bempegaldesleukin
Specified dose on specified days

Procedure: Radical cystectomy (RC)
Surgical removal of the bladder
Experimental: Arm B: Monotherapy
Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
Biological: Nivolumab
Specified dose on specified days

Procedure: Radical cystectomy (RC)
Surgical removal of the bladder
Other: Arm C: Standard-of-care
RC alone, without neoadjuvant or adjuvant therapy
Procedure: Radical cystectomy (RC)
Surgical removal of the bladder

Outcome Measures

  • Primary Outcome Measures: 1. Pathologic Complete Response (pCR) rate of Arm A to Arm C [ Time Frame: Approximately 47 months ]
  • 2. Event-Free Survival (EFS) of Arm A vs Arm C [ Time Frame: Approximately 65 months ]
  • Secondary Outcome Measures: 1. pCR rate of Arm B to Arm C [ Time Frame: Approximately 47 months ]
  • 2. EFS of Arm B vs Arm C [ Time Frame: Approximately 65 months ]
  • 3. Overall Survival (OS) [ Time Frame: Approximately 86 months ]
  • 4. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  • 5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • 6. Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
  • 7. Incidence of immune-mediated AEs (imAEs) [ Time Frame: Up to 5 years ]
  • 8. Incidence of participants with clinical laboratory abnormalities [ Time Frame: Up to 5 years ]
  • 9. pCR rate of Arm A to Arm B [ Time Frame: Approximately 47 months ]
  • 10. EFS of Arm A vs Arm B [ Time Frame: Approximately 65 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Alabama
Local Institution
Birmingham

United States, Alabama
Local Institution
Mobile

United States, Arizona
Banner MD Anderson Cancer Center
Gilbert

United States, Arizona
Arizona Cancer Center
Tucson

United States, California
UC San Diego Moores Cancer Ctr
La Jolla

United States, California
Uc Irvine Health
Orange

United States, Florida
Local Institution
Miami

United States, Florida
Local Institution
Pensacola

United States, Georgia
Local Institution
Atlanta

United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City

United States, Louisiana
Local Institution
New Orleans

United States, Maine
Local Institution
Scarborough

United States, Minnesota
Local Institution
Rochester

United States, Missouri
Local Institution
Saint Louis

United States, New Jersey
Local Institution
Belleville

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick

United States, New York
Montefiore Medical Center
Bronx

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
Local Institution
Johnson City

United States, New York
Local Institution
Lake Success

United States, New York
Local Institution
New York

United States, New York
Local Institution
New York

United States, North Carolina
Duke University
Durham

United States, Oregon
Local Institution
Eugene

United States, Pennsylvania
Lehigh Valley Health Network
Allentown

United States, Pennsylvania
Local Institution
Hershey

United States, South Carolina
Medical University Of South Carolina
Charleston

United States, Tennessee
Local Institution
Chattanooga

United States, Texas
The University Of Texas MD Anderson Cancer Center
Houston

United States, Texas
Local Institution
San Antonio

United States, Texas
Scott And White Memorial Hosp
Temple

United States, Washington
University of Washington - Seattle Cancer Care Alliance
Seattle

United States, Washington
Local Institution
Spokane Valley

United States, Washington
Northwest Medical Specialties, Pllc
Tacoma

Argentina, Buenos Aires
Instituto Alexander Fleming
Caba

Argentina, Buenos Aires
Hospital Sirio Libanes
Capital Federal

Argentina, Buenos Aires
Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires

Argentina, Buenos Aires
Hospital Italiano De La Plata
La Plata

Argentina, Distrito Federal
Local Institution
Caba

Argentina, Santa FE
Local Institution
Rosario

Argentina
Instituto Oncologico De Cordoba
Cordoba

Australia, New South Wales
Gosford Hospital
Gosford

Australia, Victoria
Ballarat Health Services
Ballarat

Australia, Victoria
St Vincent's Hospital
Fitzroy

Australia, Victoria
Austin Hospital
Heidelberg

Australia, Western Australia
St John of God Murdoch Hospital
Murdoch

Austria
Universitaetsklinikum Graz
Graz

Austria
Medizinische Universitaet Wien
Wien

Austria
Klinik Ottakring (früher: Wilhelminenspital)
Wien

Belgium
Local Institution
Brussel

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Liège

Belgium
Local Institution
Wilrijk

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, RIO Grande DO SUL
Hospital Nossa Senhora Da Conceição
Porto Alegre

Brazil, SAO Paulo
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica
Barretos

Brazil, Sao Paulo
Fundacao Doutor Amaral Carvalho
Jau

Brazil
Inca - Instituto Nacional Do Cancer
Rio De Janeiro

Brazil
Hospital Sirio Libanes
Sao Paulo

Brazil
A. C. Camargo Cancer Center
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, British Columbia
Local Institution
Surrey

Canada, Ontario
Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Sherbrooke

Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Fujian
Local Institution
Fuzhou

China, Fujian
Local Institution
Xiamen

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Heilongjiang
Local Institution
Harbin

China, Henan
Local Institution
Zhengzhou

China, Hubei
Local Institution
Wuhan

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing

China, Jiangxi
Local Institution
Nanchang

China, Shan1xi
Local Institution
Taiyuan

China, Shan3xi
Local Institution
XI An

China, Shandong
Local Institution
Jinan

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Tianjin
Local Institution
Tianjin

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Wenzhou

Czechia
Local Institution
Olomouc

Czechia
Local Institution
Praha 4

Czechia
Urologicka klinika 2. LF UK a FN Motol
Praha 5

France
Institut Sainte Catherine
Avignon Cedex 9

France
Hopital Saint Andre
Bordeaux

France
Centre Hospitalier de Cornouaille - Hopital Laennec
Brest

France
Local Institution
Caen

France
Centre Jean Perrin
Clermont-ferrand

France
Ch Departemental de Vendee
La Roche-sur-yon Cedex 9

France
Centre Leon Berard
Lyon Cedex 08

France
Institut Paoli-Calmettes
Marseille Cedex 9

France
Institut du Cancer de Montpellier
Montpellier

France
Centre Antoine Lacassagne
Nice

France
Institut Mutualiste Montsouris
Paris

France
Hopital Europeen Georges Pompidou
Paris

France
Institut Jean Godinot-Clinical Research Unit
Reims

France
Local Institution
Rennes Cedex

France
ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg

France
Hopital Foch
Suresnes

France
Local Institution
Toulouse Cedex 9

France
Hopital Bretonneau
Tours

France
Local Institution
Valenciennes

Germany
Local Institution
Chemnitz

Germany
Universitatsklinikum Carl Gustav Carus
Dresden

Germany
Uniklinikum Duesseldorf
Duesseldorf

Germany
Universitaetsklinikum Erlangen
Erlangen

Germany
Universitaetsklinikum Essen
Essen

Germany
Universitaetsklinikum Hamburg
Hamburg

Germany
Asklepios Klinik Altona
Hamburg

Germany
Local Institution
Hannover

Germany
Marien Hospital Herne
Herne

Germany
Universitaetsklinikum Jena
Jena

Germany
University Hospital Schleswig-Holstein
Luebeck

Germany
Universitaetsklinikum Muenster
Muenster

Germany
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg

Germany
Uniklinik Tuebingen
Tuebingen

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Marousi

Greece
Local Institution
Thessaloniki

Israel
Local Institution
Haifa

Israel
Local Institution
Ramat Gan

Israel
Local Institution
Tel-aviv

Italy
A.O.U. Careggi
Firenze

Italy
Local Institution
Milano

Italy
IRCCS Istituto Nazionale Tumori Milano
Milano

Italy
Local Institution
Pavia

Italy
Azienda Ospedaliera Universitaria Pisana
Pisa

Italy
Policlinico Gemelli
Roma

Italy
Istituto Clinico Humanitas IRCCS
Rozzano

Mexico, BAJA Californa SUR
Local Institution
La Paz

Mexico, Distrito Federal
Local Institution
Ciudad de Mexico

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Nuevo LEON
Local Institution
Monterey

Netherlands
Local Institution
Amsterdam

New Zealand
Local Institution
Auckland

Poland
KO-MED Biala Podlaska-Oddział Onkologii Klinicznej i Hematologii
Biala Podlaska

Poland
Local Institution
Katowice

Poland
Local Institution
Poznan

Poland
Klinika Nowotworow Ukladu Moczowego
Warszawa

Poland
Local Institution
Wroclaw

Russian Federation
Local Institution
Omsk

Russian Federation
Local Institution
Saint-Petersburg

Spain
Comp. Hosp. Univ. A Coruna
A Coruña

Spain
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona

Spain
H. Univ. Vall dHebron
Barcelona

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital General Universitario Gregorio Maranon
Madrid

Spain
Hospital Universitario Ramon Y Cajal
Madrid

Spain
Hosp Univer 12 De Octubre
Madrid

Spain
H. U. Marques de Valdecilla
Santander

Spain
Hospital Universitario Virgen Del Rocio
Sevilla

Turkey, Bornova
Local Institution
Izmir

Turkey
Local Institution
Adana

Turkey
Local Institution
Ankara

Turkey
Local Institution
Ankara

Turkey
Local Institution
Antalya

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Izmir

United Kingdom, Hertfordshire
Local Institution
Stevenage

United Kingdom
Local Institution
Bebington

United Kingdom
Local Institution
Leicester

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Wolverhampton

Sponsors and Collaborators

Bristol-Myers Squibb

Nektar Therapeutics

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04209114 History of Changes
  • Other Study ID Numbers: CA045-009, 2018-002676-40, 18-214-13
  • First Posted: December 23, 2019 Key Record Dates
  • Last Update Posted: March 21, 2022
  • Last Verified: March 2022
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: immunotherapy
    NKTR-214
    nivolumab
    bempeg
  • Additional relevant MeSH terms: Urinary Bladder Neoplasms
    Urologic Neoplasms
    Urogenital Neoplasms
    Neoplasms by Site
    Neoplasms
    Urinary Bladder Diseases
    Urologic Diseases