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Brief Title: 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.

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

INTRODUCTION

  • Org Study ID: CA045-009
  • Secondary ID: 2018-002676-40, 18-214-13
  • NTC ID: NCT04209114
  • Sponsor: Bristol-Myers Squibb
BMS Clinical Trial Information, BMS Clinical Trial Patient Recruiting, FDA Safety Alerts and Recalls

DESCRIPTION

Who is this study for?

Patients with muscle-invasive bladder cancer who are eligible for radical cystectomy and ineligible for cisplatin therapy

What is the goal of this study?

To study the effects of the combination of drugs over time, in patients who remain free of disease complications (EFS) and overall survival.

Summary

The purpose of the study is to see if 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.

Background

MIBC patients have a 50% 5 year survival rate after radical cystectomy surgery (surgery to remove bladder and nearby tissue) and a return of cancer rate, 30-54%. 1.  Therefore, additional treatment before and/or after surgery is often considered to lower the chance that the cancer returns.  Clinical studies are research tests of an investigational drug or drugs in people.  A drug must be tested in clinical studies before it may be used for patients in the general public.

You may be eligible for this clinical study if you:

Have muscle-invasive bladder cancer, cancer that has spread to the muscle wall of the bladder

Plan to have a radical cystectomy surgery, surgery to remove bladder and nearby tissue

Do not have an autoimmune disease

Are NOT eligible for cisplatin treatment

Participation in this clinical study is determined using the full eligibility requirements. Some key eligibility requirements are above. To prescreen for this study or other bladder cancer studies, please take the Bladder Cancer Screener on BMS Study Connect.

Gender: All               Minimum Age: 18 Years       Maximum Age: N/A

Study Design

Participants enrolled in the study will be randomly assigned to one of the following study treatment arms

– Arm A: Nivolumab + Bempegaldesleukin followed by Radical cystectomy (surgery) then Nivolumab + Bempegaldesleukin

– Arm B: Nivolumab followed by Radical cystectomy (surgery) then Nivolumab

-Arm C: observation only which is the current standard of care followed by Radical cystectomy (surgery) then observation only

*Participants should have surgery within 6 weeks of completion of presurgical therapy.

*Post surgery participants will continue to receive the same study treatment they received prior to surgery

Considering a clinical study?

There is a lot to think about when considering a clinical study.  Visit BMSSTUDYCONNECT.com/ to learn more and to take a screener to see if you qualify for this or other studies.

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.

  • Overall Status
    Recruiting
  • Start Date
    February 5, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants

Primary Outcome 1 - Timeframe: Approximately 36 months

Primary Outcome 2 - Measure: Event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after RC vs. SOC

Primary Outcome 2 - Timeframe: Approximately 54 months

CONDITION

  • Bladder Cancer
  • Bladder Tumor
  • Muscle-Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: please email:

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: Arizona Cancer Center
Tucson, Arizona 85737
United States
Status: Recruiting Contact: Contact
Site 0015
732-235-3272
Facility: UC San Diego Moores Cancer Ctr
La Jolla, California 92092-0698
United States
Status: Recruiting Contact: Contact
Site 0092
718-405-8404
Facility: University Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Maged Khalil, Site 0005
206-606-1909
Facility: Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Status: Recruiting Contact: Contact
Martin Angel, Site 0028
+5435142842484
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Daniel Cutuli, Site 0096
+4331638581060
Facility: Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United States
Status: Recruiting Contact: Contact
Site 0157
4185254444
Facility: Medical University Of South Carolina
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: Contact
Site 0013
+33490276262
Facility: The University Of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Kilian Gust, Site 0123
+33298526748
Facility: Scott And White Memorial Hosp
Temple, Texas 76508
United States
Status: Recruiting Contact: Contact
Site 0101
+33251446572
Facility: University of Washington - Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Site 0098
+33469856243
Facility: Northwest Medical Specialties, Pllc
Tacoma, Washington 98405
United States
Status: Recruiting Contact: Contact
Site 0100
+33467612508
Facility: Instituto Alexander Fleming
Caba, Buenos Aires 1426
Argentina
Status: Recruiting Contact: Contact
Site 0083
+33492031363
Facility: Hospital Sirio Libanes
Capital Federal, Buenos Aires 1419
Argentina
Status: Recruiting Contact: Contact
Site 0177
+33156616139
Facility: Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires 1280
Argentina
Status: Recruiting Contact: Contact
Juliana de Menezes, Site 0039
+33156093833
Facility: Hospital Italiano De La Plata
La Plata, Buenos Aires 1900
Argentina
Status: Recruiting Contact: Contact
Site 0176
+33326504485
Facility: Instituto Oncologico De Cordoba
Cordoba, New South Wales 5000
Argentina
Status: Recruiting Contact: Contact
Denis Leonardo Fontes Jardim, Site 0040
+33247479919
Facility: Local Institution
Gosford, Victoria 2250
Australia
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Maria Nirvana Formiga, Site 0038
+493514582157
Facility: Local Institution
Ballarat, Victoria 3350
Australia
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Carrie Yeung, Site 0082
+492118119353
Facility: Local Institution
Fitzroy, Victoria 3065
Australia
Status: Recruiting Contact: Contact
Site 0036
+4991318223355
Facility: Local Institution
Heidelberg, Western Australia 3084
Australia
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Vincent Castonguay, Site 0018
+4923234995252
Facility: Local Institution
Murdoch, RIO Grande DO SUL 6150
Australia
Status: Recruiting Contact: Contact
Site 0022
+4936419329956
Facility: Universitaetsklinikum Graz
Graz, RIO Grande DO SUL 8036
Austria
Status: Recruiting Contact: Contact
Site 0021
+4945150043699
Facility: Medizinische Universitaet Wien
Wien, SAO Paulo 1090
Austria
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Antonin Brisuda, Site 0020
+492518349949
Facility: Local Institution
Wien, Sao Paulo 1160
Austria
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Werner Hilgers, Site 0077
+499113983085
Facility: Local Institution
Brussel, Alberta 1090
Belgium
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Marine Gross-Goupil, Site 0091
+302105832196
Facility: Local Institution
Edegem, Ontario 2650
Belgium
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Hakim Mahammedi, Site 0151
+302310693253
Facility: Local Institution
Gent, Quebec 9000
Belgium
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Frank Priou, Site 0059
+3923902876
Facility: Local Institution
Wilrijk, BAJA Californa SUR 2610
Belgium
Status: Recruiting Contact: Contact
Gwenaelle Gravis, Site 0057
+390630154945
Facility: Hospital Nossa Senhora Da Conceição
Porto Alegre, Distrito Federal 91350-200
Brazil
Status: Recruiting Contact: Contact
Delphine Borchiellini, Site 0070
+48225462433
Facility: Fundacao Doutor Amaral Carvalho
Jau, Distrito Federal 17210-080
Brazil
Status: Recruiting Contact: Contact
Stephane Oudard, Site 0060
+34934978925
Facility: Inca - Instituto Nacional Do Cancer
Rio De Janeiro, Nuevo LEON 20231-050
Brazil
Status: Recruiting Contact: Contact
Jean-Christophe Eymard, Site 0161
+34932746000
Facility: Hospital Sirio Libanes
Sao Paulo, Bornova 01308-050
Brazil
Status: Recruiting Contact: Contact
Philippe Barthelemy, Site 0058
+34957011448
Facility: Fundacao Antonio Prudente-Hospital Ac Camargo
Sao Paulo, Hertfordshire 01509-900
Brazil
Status: Recruiting Contact: Contact
Thierry Lebret, Site 0056
+34915868115
Facility: Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa, L1G 2B9
Canada
Status: Recruiting Contact: Contact
Guenter Niegisch, Site 0117
+34942202525
Facility: Local Institution
Sherbrooke, J1H 5N4
Canada
Status: Recruiting Contact: Contact
Site 0050

Facility: CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec, G1R 2J6
Canada
Status: Recruiting Contact: Contact
Site 0052

Facility: Local Institution
Olomouc, 77900
Czechia
Status: Recruiting Contact: Contact
Site 0051

Facility: Local Institution
Praha 4, 140 59
Czechia
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Florian Roghmann, Site 0049

Facility: Urologicka klinika 2. LF UK a FN Motol
Praha 5, 150 06
Czechia
Status: Recruiting Contact: Contact
Marc-Oliver Grimm, Site 0045

Facility: Institut Sainte Catherine
Avignon Cedex 9, 84918
France
Status: Recruiting Contact: Contact
Mario Kramer, Site 0053

Facility: Hopital Saint Andre
Bordeaux, 33075
France
Status: Recruiting Contact: Contact
Martin Boegemann, Site 0113

Facility: Centre Hospitalier de Cornouaille - Hopital Laennec
Brest, 29200
France
Status: Recruiting Contact: Contact
Sascha Pahernik, Site 0048

Facility: Centre Jean Perrin
Clermont-ferrand, 63000
France
Status: Recruiting Contact: Contact
Aristotelis Bamias, Site 0033

Facility: Ch Departemental de Vendee
La Roche-sur-yon Cedex 9, 85925
France
Status: Recruiting Contact: Contact
Marinos Tsiatas, Site 0088

Facility: Centre Leon Berard
Lyon Cedex 08, 69373
France
Status: Recruiting Contact: Contact
Christos Papandreou, Site 0035

Facility: Institut Paoli-Calmettes
Marseille Cedex 9, 13273
France
Status: Recruiting Contact: Contact
Site 0129

Facility: Institut du Cancer de Montpellier
Montpellier, 34298
France
Status: Recruiting Contact: Contact
Site 0130

Facility: Centre Antoine Lacassagne
Nice, 06189
France
Status: Recruiting Contact: Contact
Site 0131

Facility: Institut Mutualiste Montsouris
Paris, 75014
France
Status: Recruiting Contact: Contact
Site 0149

Facility: Hopital Europeen Georges Pompidou
Paris, 75015
France
Status: Recruiting Contact: Contact
Site 0162

Facility: Institut Jean Godinot-Clinical Research Unit
Reims, 51100
France
Status: Recruiting Contact: Contact
Giuseppe Procopio, Site 0025

Facility: ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg, 67200
France
Status: Recruiting Contact: Contact
Luca Galli, Site 0026

Facility: Hopital Foch
Suresnes, 92151
France
Status: Recruiting Contact: Contact
Giampaolo Tortora, Site 0065

Facility: Hopital Bretonneau
Tours, 37000
France
Status: Recruiting Contact: Contact
Site 0154

Facility: Universitatsklinikum Carl Gustav Carus
Dresden, 01307
Germany
Status: Recruiting Contact: Contact
Site 0133

Facility: Uniklinikum Duesseldorf
Duesseldorf, 40225
Germany
Status: Recruiting Contact: Contact
Site 0069

Facility: Universitaetsklinikum Erlangen
Erlangen, 91054
Germany
Status: Recruiting Contact: Contact
Site 0167

Facility: Local Institution
Essen, 45122
Germany
Status: Recruiting Contact: Contact
Site 0055

Facility: Local Institution
Hamburg, 20246
Germany
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Pawel Wiechno, Site 0054

Facility: Local Institution
Hamburg, 22453
Germany
Status: Recruiting Contact: Contact
Site 0016

Facility: Marien Hospital Herne
Herne, 44625
Germany
Status: Recruiting Contact: Contact
Aurea Molina Diaz, Site 0104

Facility: Universitaetsklinikum Jena
Jena, 07747
Germany
Status: Recruiting Contact: Contact
Olatz Etxaniz, Site 0106

Facility: University Hospital Schleswig-Holstein
Luebeck, 23538
Germany
Status: Recruiting Contact: Contact
Rafael Morales Barrera, Site 0110

Facility: Universitaetsklinikum Muenster
Muenster, 48149
Germany
Status: Recruiting Contact: Contact
MARIA JOSE MENDEZ VIDAL, Site 0109

Facility: Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg, 90419
Germany
Status: Recruiting Contact: Contact
Jose Arranz Arija, Site 0105

Facility: Local Institution
Tuebingen, 72076
Germany
Status: Recruiting Contact: Contact
Teresa Alonso Gordoa, Site 0108

Facility: University General Hospital of Athens Attikon
Athens, 12462
Greece
Status: Recruiting Contact: Contact
Daniel Castellano Gauna, Site 0103

Facility: Athens Medical Center
Marousi, 15125
Greece
Status: Recruiting Contact: Contact
Ignacio Duran Martinez, Site 0107

Facility: Papageorgiou General Hospital
Thessaloniki, 56429
Greece
Status: Recruiting Contact: Contact
Begona Perez Valderrama, Site 0111

Facility: Local Institution
Haifa, 3109601
Israel
Status: Recruiting Contact: Contact
Site 0169

Facility: Local Institution
Ramat Gan, 52621
Israel
Status: Recruiting Contact: Contact
Site 0170

Facility: Local Institution
Tel-aviv, 64239
Israel
Status: Recruiting Contact: Contact
Site 0173

Facility: Local Institution
Firenze, 50134
Italy
Status: Recruiting Contact: Contact
Site 0171

Facility: IRCCS Istituto Nazionale Tumori Milano
Milano, 20133
Italy
Status: Recruiting Contact: Contact
Site 0085

Facility: Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Italy
Status: Recruiting Contact: N/A
Facility: Policlinico Gemelli
Roma, 00168
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Clinico Humanitas IRCCS
Rozzano, 20089
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution
La Paz, 23040
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Ciudad de Mexico, 06100
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Mexico, 06700
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Monterey, 64460
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Amsterdam, 1066CX
Netherlands
Status: Recruiting Contact: N/A
Facility: Klinika Nowotworow Ukladu Moczowego
Warszawa, 02-781
Poland
Status: Recruiting Contact: N/A
Facility: Local Institution
Omsk, 644013
Russian Federation
Status: Recruiting Contact: N/A
Facility: Local Institution
Saint-Petersburg, 197758
Russian Federation
Status: Recruiting Contact: N/A
Facility: Comp. Hosp. Univ. A Coruna
A Coruña, 15006
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Germans Trias I Pujol
Badalona-barcelona, 08916
Spain
Status: Recruiting Contact: N/A
Facility: H. Univ. Vall dHebron
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Reina Sofia
Cordoba, 14004
Spain
Status: Recruiting Contact: N/A
Facility: Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hosp Univer 12 De Octubre
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: H. U. Marques de Valdecilla
Santander, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen Del Rocio
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution
Leicester, LE1 5WW
United Kingdom
Status: Recruiting Contact: N/A
Facility: Local Institution
London, W6 8RF
United Kingdom
Status: Recruiting Contact: N/A