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NCT03661320 Clinical Trial

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Urinary Bladder Neoplasms Clinical Trial

Official title:
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03661320
Other study ID # CA017-078
Secondary ID 2017-004692-31
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 6, 2018
Est. completion date December 30, 2027

Study information
Verified date January 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 861
Est. completion date December 30, 2027
Est. primary completion date April 4, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Exclusion Criteria: - Clinical evidence of positive lymph node(s) (LN) (= 10 mm in short axis) or metastatic bladder cancer - Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Nivolumab
Specified dose on specified days
Drug:
• Gemcitabine
Specified dose on specified days
• Cisplatin
Specified dose on specified days

Locations
Country Name City State
Argentina Local Institution - 0051 Capital Federal Buenos Aires
Argentina Local Institution - 0151 Ciudad Autonoma Buenos Aires Distrito Federal
Argentina Local Institution - 0049 Ciudad Autónoma de Buenos Aires Buenos Aires
Australia Local Institution - 0131 Garran Australian Capital Territory
Australia Local Institution - 0037 Heidelberg Victoria
Australia Local Institution - 0130 Kingswood New South Wales
Australia Local Institution - 0157 Macquarie University New South Wales
Australia Local Institution - 0038 Murdoch Western Australia
Australia Local Institution - 0143 North Adelaide South Australia
Australia Local Institution - 0043 St Leonards New South Wales
Austria Local Institution - 0090 Klagenfurt Am Woerthersee
Austria Local Institution - 0091 Krems
Austria Local Institution - 0011 Linz
Austria Local Institution - 0012 Wien
Belgium Local Institution - 0060 Bruxelles
Belgium Local Institution - 0063 Gent
Belgium Local Institution - 0062 Wilrijk
Brazil Local Institution - 0098 Barretos Sao Paulo
Brazil Local Institution - 0094 Fortaleza Ceara
Brazil Local Institution - 0092 Ijui RIO Grande DO SUL
Brazil Local Institution - 0099 Ipatinga Minas Gerais
Brazil Local Institution - 0095 Jau Sao Paulo
Brazil Local Institution - 0097 Porto Alegre RIO Grande DO SUL
Brazil Local Institution - 0212 Porto Alegre RIO Grande DO SUL
Brazil Local Institution - 0164 Rio De Janeiro
Brazil Local Institution - 0093 Sao Jose Do Rio Preto Sao Paulo
Brazil Local Institution - 0214 Sao Paulo
Canada Local Institution - 0192 Chicoutimi Quebec
Canada Local Institution - 0159 Kelowna British Columbia
Canada Local Institution - 0190 Montreal Quebec
Canada Local Institution - 0182 North York Ontario
Chile Local Institution - 0052 Santiago Metropolitana
Chile Local Institution - 0053 Santiago Metropolitana
Chile Local Institution - 0054 Santiago Metropolitana
Chile Local Institution - 0210 Santiago Metropolitana
Colombia Local Institution - 0104 Bucaramanga
Colombia Local Institution - 0201 Colombia Bogota
Colombia Local Institution - 0103 Monteria
Finland Local Institution - 0148 Helsinki
Finland Local Institution - 0145 Tampere
Finland Local Institution - 0146 Turku
France Local Institution - 0205 Amiens
France Local Institution - 0198 Angers
France Local Institution - 0101 Besancon
France Local Institution - 0217 Bordeaux
France Local Institution - 0202 Brest Cedex
France Local Institution - 0199 Clermont-ferrand
France Local Institution - 0204 Créteil Val-de-Marne
France Local Institution - 0206 La Tronche
France Local Institution - 0075 Marseille
France Local Institution - 0200 Montpellier Cedex 5
France Local Institution - 0074 Nice
France Local Institution - 0163 Paris
France Local Institution - 0020 Pierre Benite Cedax
France Local Institution - 0188 Saint Herblain Cedex
France Local Institution - 0002 Strasbourg Cedex
France Local Institution - 0003 TOULOUSE Cedex 9
Germany Local Institution - 0078 Aachen
Germany Local Institution - 0015 Erfurt
Germany Local Institution - 0081 Essen
Germany Local Institution - 0086 Frankfurt Main
Germany Local Institution - 0080 Goettingen
Germany Local Institution - 0013 Herne
Germany Local Institution - 0010 Jena
Germany Local Institution - 0084 Luebeck
Germany Local Institution - 0079 Magdeburg
Germany Local Institution - 0100 Mainz Rheinland-Pfalz
Germany Local Institution - 0082 Muenchen
Germany Local Institution - 0016 Nuernberg
Germany Local Institution - 0085 Trier
Greece Local Institution - 0195 Athens Attikí
Greece Local Institution - 0194 Chaidari
Greece Local Institution - 0031 Larissa Thessalía
Israel Local Institution - 0068 Beer Sheva
Israel Local Institution - 0066 Haifa
Israel Local Institution - 0067 Ramat Gan
Israel Local Institution - 0196 Tel Aviv Tel-Aviv
Italy Local Institution - 0064 Bari
Italy Local Institution - 0193 Forlì
Italy Local Institution - 0032 Milano
Italy Local Institution - 0065 Modena
Italy Local Institution - 0033 Padova
Italy Local Institution - 0034 Pisa
Italy Local Institution - 0035 Roma
Japan Local Institution - 0174 Fukuoka
Japan Local Institution - 0170 Hamamatasu Shizuoka
Japan Local Institution - 0176 Hidaka-shi Saitama
Japan Local Institution - 0171 Kita-gun Kagawa
Japan Local Institution - 0186 Komaki Aichi
Japan Local Institution - 0180 Kyoto
Japan Local Institution - 0178 Minato-ku Tokyo
Japan Local Institution - 0168 Niigata-shi Niigata
Japan Local Institution - 0173 Osakasayama Osaka
Japan Local Institution - 0177 Sapporo Hokkaido
Japan Local Institution - 0184 Sapporo Hokkaido
Japan Local Institution - 0185 Sapporo Hokkaido
Japan Local Institution - 0172 Shinjuku-ku Tokyo
Japan Local Institution - 0175 Takatsuki City Osaka
Japan Local Institution - 0179 Tsukuba-shi Ibaraki
Japan Local Institution - 0169 Yokohama Kanagawa
Korea, Republic of Local Institution - 0220 Busan
Korea, Republic of Local Institution - 0218 Daegu
Korea, Republic of Local Institution - 0137 Goyang-si Gyeonggi-do
Korea, Republic of Local Institution - 0208 Gyeongsangnam-do
Korea, Republic of Local Institution - 0203 Seongnam-si Kyonggi-do
Korea, Republic of Local Institution - 0215 Seongnam-si,
Korea, Republic of Local Institution - 0136 Seoul
Korea, Republic of Local Institution - 0138 Seoul
Korea, Republic of Local Institution - 0140 Seoul
Korea, Republic of Local Institution - 0211 Seoul
Mexico Local Institution - 0105 Colima
Mexico Local Institution - 0160 La Paz BAJA Californa SUR
Mexico Local Institution - 0056 Monterrey Nuevo LEON
Mexico Local Institution - 0102 Zapopan Jalisco
Netherlands Local Institution - 0070 Amsterdam
Netherlands Local Institution - 0072 Groningen
Netherlands Local Institution - 0073 Sittard-Geleen
New Zealand Local Institution - 0087 Auckland
New Zealand Local Institution - 0089 Christchurch
Norway Local Institution - 0158 Gralum
Norway Local Institution - 0132 Lorenskog
Norway Local Institution - 0133 Oslo
Portugal Local Institution - 0153 Lisboa
Portugal Local Institution - 0152 Porto
Romania Local Institution - 0219 Cluj-Napoca
Romania Local Institution - 0076 Craiova
Romania Local Institution - 0058 Sector 2
Russian Federation Local Institution Saint-Petersburg
Russian Federation Local Institution St Petersburg
Singapore Local Institution - 0154 Singapore
Spain Local Institution - 0113 Lugo
Spain Local Institution - 0111 Madrid
Spain Local Institution - 0112 Madrid
Spain Local Institution - 0114 Madrid
Spain Local Institution - 0156 Malaga
Spain Local Institution - 0109 Sevilla
Taiwan Local Institution - 0135 Kaohsiung
Taiwan Local Institution - 0165 Taichung
Taiwan Local Institution - 0139 Taipei
Taiwan Local Institution - 0141 Taipei City
United Kingdom Local Institution - 0128 Chelmsford Essex
United Kingdom Local Institution - 0122 Glasgow
United Kingdom Local Institution - 0117 Lancaster
United Kingdom Local Institution - 0121 London
United Kingdom Local Institution - 0124 Oxford
United Kingdom Local Institution - 0127 York Yorkshire
United States Local Institution - 0029 Albany New York
United States Local Institution - 0144 Atlanta Georgia
United States Local Institution - 0030 Austin Texas
United States Local Institution - 0009 Boston Massachusetts
United States Local Institution - 0166 Boston Massachusetts
United States Local Institution - 0209 Boston Massachusetts
United States Local Institution - 0189 Charleston South Carolina
United States Local Institution - 0005 Chicago Illinois
United States Local Institution - 0191 Cleveland Ohio
United States Local Institution - 0181 Columbia Maryland
United States Local Institution - 0069 Lake Success New York
United States Local Institution - 0024 Las Vegas Nevada
United States Local Institution - 0021 Littleton Colorado
United States Local Institution - 0025 Minneapolis Minnesota
United States Local Institution - 0129 Minneapolis Minnesota
United States Local Institution - 0007 Nashville Tennessee
United States Local Institution - 0047 New York New York
United States Local Institution - 0023 Norfolk Virginia
United States Local Institution - 0001 Omaha Nebraska
United States Local Institution - 0183 Omaha Nebraska
United States Local Institution - 0036 Pensacola Florida
United States Local Institution - 0006 Peoria Illinois
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Local Institution - 0004 Tampa Florida
United States Local Institution - 0028 Tigard Oregon
United States Local Institution - 0022 Tucson Arizona

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Portugal,  Romania,  Russian Federation,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathological Complete Response (pCR) rate, in all randomized participants Arm B vs. Arm A Approximately 43 months
Primary Event-Free Survival (EFS), in all randomized participants Arm B vs. Arm A Approximately 51 months
Secondary Overall Survival (OS) in all randomized participants Arm B vs. Arm A Approximately 60 months
Secondary Incidence of Adverse Events (AE) in participants who received at least one treatment dose Approximately 60 months
Secondary Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose Approximately 60 months
Secondary Incidence of deaths in participants who received at least one treatment dose Approximately 60 months
Secondary Incidence of laboratory abnormalities in participants who received at least one treatment dose Approximately 60 months
Secondary pCR rate, descriptively in all concurrently randomized participants Arm C vs. Arm B and Arm A Approximately 43 months
Secondary EFS, descriptively in all concurrently randomized participants Arm C vs. Arm B and Arm A Approximately 51 months
Secondary OS, descriptively in all concurrently randomized participants Arm C vs. Arm B and Arm A Approximately 60 months
See also
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Not yet recruiting NCT02534623 - Postoperative Quality of Recovery After Transurethral Resection of the Bladder N/A
Recruiting NCT02228473 - Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort N/A
Completed NCT02778243 - Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level N/A
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Completed NCT01688999 - Cabozantinib for Advanced Urothelial Cancer Phase 2
Completed NCT03219333 - A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Phase 2
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Terminated NCT02560038 - Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer Phase 2
Not yet recruiting NCT02252445 - Propofol and Sevoflurane for Catheter-Related Bladder Discomfort N/A
Not yet recruiting NCT02760953 - TURBt With Adjuvant Cryoablation to Treat Bladder Cancer N/A
Terminated NCT04430036 - AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Phase 2
Active, not recruiting NCT06289283 - Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
Active, not recruiting NCT03288545 - A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer Phase 1/Phase 2
Completed NCT01478685 - A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors Phase 1
Completed NCT03404791 - A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy Phase 1
Terminated NCT01479348 - Imaging Study for FdCyd and THU Cancer Treatment Early Phase 1
Recruiting NCT05742867 - A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
Recruiting NCT03973671 - Prospective Sample Collection for Cancer of Bladder

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