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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 Has 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

    October 18, 2021

Study Description

Brief summary:

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

  • Condition or Disease:Muscle-Invasive Bladder Cancer
    Bladder Tumor
    Bladder Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Bempeg
    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 Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: August 2023
  • Estimated Study Completion Date: September 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Combination
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: Bempeg
Specified dose on specified days

Procedure: Radical cystectomy (RC)
Surgical removal of the bladder
Experimental: 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: 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 neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants [ Time Frame: Approximately 36 months ]
  • 2. Event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after RC vs. SOC [ Time Frame: Approximately 54 months ]
  • Secondary Outcome Measures: 1. pCR rate of neoadjuvant nivolumab monotherapy to SOC at the time of surgery in all randomized participants [ Time Frame: Approximately 36 months ]
  • 2. EFS of neoadjuvant nivolumab followed by adjuvant nivolumab vs. SOC [ Time Frame: Approximately 54 months ]
  • 3. Overall survival [ Time Frame: Approximately 74 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 laboratory abnormalities [ Time Frame: Up to 5 years ]

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT) and confirmed by radiographic imaging. - 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% - Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Clinical evidence of pathologic lymph node (LN) 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 Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

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

Locations

Italy
Policlinico Gemelli
Roma

Italy
Local Institution
Firenze

Italy
Local Institution
Milano

Italy
IRCCS Istituto Nazionale Tumori Milano
Milano

Italy
Local Institution
Pavia

Italy
Azienda Ospedaliera Universitaria Pisana
Pisa

Italy
Istituto Clinico Humanitas IRCCS
Rozzano

Australia, New South Wales
Local Institution
Gosford

Australia, Victoria
Local Institution
Ballarat

Australia, Victoria
Local Institution
Fitzroy

Australia, Victoria
Local Institution
Heidelberg

Australia, Western Australia
Local Institution
Murdoch

United States, Alabama
Local Institution
Birmingham

United States, Alabama
Local Institution
Mobile

United States, Arizona
Local Institution
Gilbert

United States, Arizona
Arizona Cancer Center
Tucson

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

United States, California
Local Institution
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

Austria
Universitaetsklinikum Graz
Graz

Austria
Medizinische Universitaet Wien
Wien

Austria
Local Institution
Wien

Belgium
Local Institution
Brussel

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Liege

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
Local Institution
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
Fundacao Antonio Prudente-Hospital Ac Camargo
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

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
Local Institution
Essen

Germany
Local Institution
Hamburg

Germany
Local Institution
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
Local Institution
Tuebingen

Greece
University General Hospital of Athens Attikon
Athens

Greece
Athens Medical Center
Marousi

Greece
Papageorgiou General Hospital
Thessaloniki

Israel
Local Institution
Haifa

Israel
Local Institution
Ramat Gan

Israel
Local Institution
Tel-aviv

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
Local Institution
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
Ankara

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

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: October 18, 2021
  • Last Verified: October 2021
  • 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: bempeg
    nivolumab
    NKTR-214
    immunotherapy
  • Additional relevant MeSH terms: Urinary Bladder Neoplasms