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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 Bempegaldesleukin (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
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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 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.

  • 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 Arm A to Arm C

Primary Outcome 1 - Timeframe: Approximately 47 months

Primary Outcome 2 - Measure: Event-Free Survival (EFS) of Arm A vs Arm C

Primary Outcome 2 - Timeframe: Approximately 65 months

CONDITION

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

ELIGIBILITY

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

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: 855-907-3286

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: Contact
Rana McKay, Site 0029
858-822-5398
Facility: Arizona Cancer Center
Tucson, Arizona 85737
United States
Status: Recruiting Contact: Contact
Edward Uchio, Site 0015
714-456-6801
Facility: UC San Diego Moores Cancer Ctr
La Jolla, California 92092-0698
United States
Status: Recruiting Contact: Contact
Site 0092
319-353-8914
Facility: Uc Irvine Health
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Yousef Zakharia, Site 0002
732-235-3272
Facility: University Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Maged Khalil, Site 0005
254-724-5939
Facility: Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Status: Recruiting Contact: Contact
Daniel Cutuli, Site 0096
+005491153384489
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Ernesto Korbenfeld, Site 0027
+5435142842484
Facility: Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United States
Status: Recruiting Contact: Contact
Kynan Feeney, Site 0013
+43491502141
Facility: The University Of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Site 0101
+552132076564
Facility: Scott And White Memorial Hosp
Temple, Texas 76508
United States
Status: Recruiting Contact: Contact
Site 0068
+551121895021
Facility: University of Washington - Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Site 0100
905576871134517
Facility: Northwest Medical Specialties, Pllc
Tacoma, Washington 98405
United States
Status: Recruiting Contact: Contact
Site 0177
+420224434848
Facility: Instituto Alexander Fleming
Caba, Buenos Aires 1426
Argentina
Status: Recruiting Contact: Contact
Juliana de Menezes, Site 0039
+33490276262
Facility: Hospital Sirio Libanes
Capital Federal, Buenos Aires 1419
Argentina
Status: Recruiting Contact: Contact
Daniel D Almeida Preto, Site 0176
+33556794708
Facility: Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires 1280
Argentina
Status: Recruiting Contact: Contact
Patricia Beato, Site 0037
+33298526748
Facility: Hospital Italiano De La Plata
La Plata, Buenos Aires 1900
Argentina
Status: Recruiting Contact: Contact
Victor Marcondes Lopes dos Santos, Site 0041
+33473278005
Facility: Local Institution
Rosario, Santa FE S2000
Argentina
Status: Recruiting Contact: Contact
Maria Nirvana Formiga, Site 0038
+33469856243
Facility: Instituto Oncologico De Cordoba
Cordoba, New South Wales 5000
Argentina
Status: Recruiting Contact: Contact
Site 0212
+33491223736
Facility: Gosford Hospital
Gosford, Victoria 2250
Australia
Status: Recruiting Contact: Contact
Carrie Yeung, Site 0082
+33467612508
Facility: Ballarat Health Services
Ballarat, Victoria 3350
Australia
Status: Recruiting Contact: Contact
Site 0036
+33492031363
Facility: St Vincent's Hospital
Fitzroy, Victoria 3065
Australia
Status: Recruiting Contact: Contact
Vincent Castonguay, Site 0018
+33156616139
Facility: Austin Hospital
Heidelberg, Western Australia 3084
Australia
Status: Recruiting Contact: Contact
Site 0182
+33156093833
Facility: St John of God Murdoch Hospital
Murdoch, RIO Grande DO SUL 6150
Australia
Status: Recruiting Contact: Contact
Site 0183
+33326504485
Facility: Universitaetsklinikum Graz
Graz, RIO Grande DO SUL 8036
Austria
Status: Recruiting Contact: Contact
Site 0204
+33368766666
Facility: Medizinische Universitaet Wien
Wien, SAO Paulo 1090
Austria
Status: Recruiting Contact: Contact
Site 0200
+33146252487
Facility: Klinik Ottakring (früher: Wilhelminenspital)
Wien, Sao Paulo 1160
Austria
Status: Recruiting Contact: Contact
Site 0211
+33247479919
Facility: Local Institution
Brussel, Alberta 1090
Belgium
Status: Recruiting Contact: Contact
Site 0179
+492118119353
Facility: Local Institution
Edegem, Ontario 2650
Belgium
Status: Recruiting Contact: Contact
Site 0188
+4920172383146
Facility: Local Institution
Gent, Quebec 9000
Belgium
Status: Recruiting Contact: Contact
Site 0215
+4940741056428
Facility: Local Institution
Liège, Quebec 4000
Belgium
Status: Recruiting Contact: Contact
Site 0210
+49401818811218
Facility: Local Institution
Wilrijk, Beijing 2610
Belgium
Status: Recruiting Contact: Contact
Site 0206
+4923234995252
Facility: Hospital Nossa Senhora Da Conceição
Porto Alegre, Chongqing 91350-200
Brazil
Status: Recruiting Contact: Contact
Site 0184
+4945150043699
Facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica
Barretos, Fujian 14784-400
Brazil
Status: Recruiting Contact: Contact
Site 0207
+492518349949
Facility: Fundacao Doutor Amaral Carvalho
Jau, Fujian 17210-080
Brazil
Status: Recruiting Contact: Contact
Site 0198
+499113983085
Facility: Inca - Instituto Nacional Do Cancer
Rio De Janeiro, Guangdong 20231-050
Brazil
Status: Recruiting Contact: Contact
Site 0214
+4970712985268
Facility: Hospital Sirio Libanes
Sao Paulo, Guangdong 01308-050
Brazil
Status: Recruiting Contact: Contact
Site 0194
+3923902876
Facility: A. C. Camargo Cancer Center
Sao Paulo, Heilongjiang 01509-900
Brazil
Status: Recruiting Contact: Contact
Site 0181
+39050558618
Facility: Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa, Jiangsu L1G 2B9
Canada
Status: Recruiting Contact: Contact
Site 0196
+48225462433
Facility: Local Institution
Sherbrooke, Shan1xi J1H 5N4
Canada
Status: Recruiting Contact: Contact
Site 0022
+34934978925
Facility: CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec, Shan3xi G1R 2J6
Canada
Status: Recruiting Contact: Contact
Site 0021
+34932746000
Facility: Local Institution
Olomouc, 140 59
Czechia
Status: Recruiting Contact: Contact
Mario Kramer, Site 0053

Facility: Local Institution
Praha 4, 150 06
Czechia
Status: Recruiting Contact: Contact
Martin Boegemann, Site 0113

Facility: Urologicka klinika 2. LF UK a FN Motol
Praha 5, 84918
Czechia
Status: Recruiting Contact: Contact
Sascha Pahernik, Site 0048

Facility: Institut Sainte Catherine
Avignon Cedex 9, 33075
France
Status: Recruiting Contact: Contact
Jens Bedke, Site 0046

Facility: Hopital Saint Andre
Bordeaux, 29200
France
Status: Recruiting Contact: Contact
Site 0178

Facility: Centre Hospitalier de Cornouaille - Hopital Laennec
Brest, 14076
France
Status: Recruiting Contact: Contact
Site 0033

Facility: Centre Jean Perrin
Clermont-ferrand, 85925
France
Status: Recruiting Contact: Contact
Site 0035

Facility: Ch Departemental de Vendee
La Roche-sur-yon Cedex 9, 69373
France
Status: Recruiting Contact: Contact
Site 0129

Facility: Centre Leon Berard
Lyon Cedex 08, 13273
France
Status: Recruiting Contact: Contact
Site 0130

Facility: Institut Paoli-Calmettes
Marseille Cedex 9, 34298
France
Status: Recruiting Contact: Contact
Site 0131

Facility: Institut du Cancer de Montpellier
Montpellier, 06189
France
Status: Recruiting Contact: Contact
Lorenzo Antonuzzo, Site 0149

Facility: Centre Antoine Lacassagne
Nice, 75014
France
Status: Recruiting Contact: Contact
Site 0162

Facility: Institut Mutualiste Montsouris
Paris, 75015
France
Status: Recruiting Contact: Contact
Giuseppe Procopio, Site 0025

Facility: Hopital Europeen Georges Pompidou
Paris, 51100
France
Status: Recruiting Contact: Contact
Site 0043

Facility: Institut Jean Godinot-Clinical Research Unit
Reims, 35042
France
Status: Recruiting Contact: Contact
Luca Galli, Site 0026

Facility: ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg, 92151
France
Status: Recruiting Contact: Contact
Paolo Zucali, Site 0044

Facility: Hopital Foch
Suresnes, 31059
France
Status: Recruiting Contact: Contact
Site 0154

Facility: Hopital Bretonneau
Tours, 59300
France
Status: Recruiting Contact: Contact
Site 0160

Facility: Uniklinikum Duesseldorf
Duesseldorf, 91054
Germany
Status: Recruiting Contact: Contact
Site 0055

Facility: Universitaetsklinikum Erlangen
Erlangen, 45122
Germany
Status: Recruiting Contact: Contact
Pawel Wiechno, Site 0054

Facility: Universitaetsklinikum Essen
Essen, 20246
Germany
Status: Recruiting Contact: Contact
Aurea Molina Diaz, Site 0104

Facility: Universitaetsklinikum Hamburg
Hamburg, 22453
Germany
Status: Recruiting Contact: Contact
Olatz Etxaniz Ulazia, Site 0106

Facility: Asklepios Klinik Altona
Hamburg, 30625
Germany
Status: Recruiting Contact: Contact
Rafael Morales Barrera, Site 0110

Facility: Marien Hospital Herne
Herne, 07747
Germany
Status: Recruiting Contact: Contact
Jose Arranz Arija, Site 0105

Facility: Universitaetsklinikum Jena
Jena, 23538
Germany
Status: Recruiting Contact: Contact
Teresa Alonso Gordoa, Site 0108

Facility: University Hospital Schleswig-Holstein
Luebeck, 48149
Germany
Status: Recruiting Contact: Contact
Daniel Castellano Gauna, Site 0103

Facility: Universitaetsklinikum Muenster
Muenster, 90419
Germany
Status: Recruiting Contact: Contact
Ignacio Duran Martinez, Site 0107

Facility: Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg, 72076
Germany
Status: Recruiting Contact: Contact
Begona Perez Valderrama, Site 0111

Facility: Uniklinik Tuebingen
Tuebingen, 11528
Germany
Status: Recruiting Contact: Contact
Site 0216

Facility: Local Institution
Athens, 15125
Greece
Status: Recruiting Contact: Contact
Site 0221

Facility: Local Institution
Marousi, 56429
Greece
Status: Recruiting Contact: Contact
Site 0219

Facility: Local Institution
Thessaloniki, 3109601
Greece
Status: Recruiting Contact: Contact
Site 0217

Facility: Local Institution
Haifa, 52621
Israel
Status: Recruiting Contact: Contact
Site 0079

Facility: Local Institution
Ramat Gan, 64239
Israel
Status: Recruiting Contact: Contact
Site 0085

Facility: Local Institution
Tel-aviv, 50134
Israel
Status: Recruiting Contact: Contact
Site 0042

Facility: A.O.U. Careggi
Firenze, 20132
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS Istituto Nazionale Tumori Milano
Milano, 27100
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Universitaria Pisana
Pisa, 00168
Italy
Status: Recruiting Contact: N/A
Facility: Policlinico Gemelli
Roma, 20089
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Clinico Humanitas IRCCS
Rozzano, 23040
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution
La Paz, 06100
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Ciudad de Mexico, 06700
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Mexico, 14000
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Monterey, 1066CX
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Amsterdam, 1023
Netherlands
Status: Recruiting Contact: N/A
Facility: KO-MED Biala Podlaska-Oddział Onkologii Klinicznej i Hematologii
Biala Podlaska, 40-514
Poland
Status: Recruiting Contact: N/A
Facility: Klinika Nowotworow Ukladu Moczowego
Warszawa, 53-413
Poland
Status: Recruiting Contact: N/A
Facility: Comp. Hosp. Univ. A Coruna
A Coruña, 08916
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Germans Trias I Pujol
Badalona-barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: H. Univ. Vall dHebron
Barcelona, 14004
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Reina Sofia
Cordoba, 28007
Spain
Status: Recruiting Contact: N/A
Facility: Hospital General Universitario Gregorio Maranon
Madrid, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon Y Cajal
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Hosp Univer 12 De Octubre
Madrid, 39008
Spain
Status: Recruiting Contact: N/A
Facility: H. U. Marques de Valdecilla
Santander, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen Del Rocio
Sevilla, 35100
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution
Leicester, EC1M 6BQ
United Kingdom
Status: Recruiting Contact: N/A
Facility: Local Institution
London, WC1E 6BT
United Kingdom
Status: Recruiting Contact: N/A