AzTrials
AzTrials

Urothelial CancerPhase 3CheckMate901NCT03036098

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

A Phase 3 study testing Nivolumab, Ipilimumab and Gemcitabine in people with Urothelial Cancer, run by Bristol-Myers Squibb at 174 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer
What is being tested?
Nivolumab, Ipilimumab and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,314 participants
Where
174 sitesin 30 countries
Study dates
24 Mar 2017to 15 May 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
  • No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Women and men must agree to follow specific methods of contraception, if applicable

Who cannot join

  • Disease that is suitable for local therapy administered with curative intent
  • Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

174 sites in 30 countries.

174 sites in 30 countries

United States29 sites

  • Local Institution - 0084

    Albuquerque, New Mexico, 87131

  • Local Institution - 0001

    Anchorage, Alaska, 99503

  • Local Institution - 0063

    Ann Arbor, Michigan, 48197

  • Local Institution - 0004

    Athens, Georgia, 30607

  • Local Institution - 0051

    Boca Raton, Florida, 33486

  • Local Institution - 0056

    Boston, Massachusetts, 02210

  • Local Institution - 0073

    Boston, Massachusetts, 02215

  • Local Institution - 0208

    Boston, Massachusetts, 02215

  • Local Institution - 0083

    Buffalo, New York, 14263

  • Local Institution - 0002

    Burnsville, Minnesota, 55337

  • Local Institution - 0046

    Chicago, Illinois, 60612

  • Local Institution - 0082

    Columbus, Ohio, 43210

  • Local Institution - 0116

    Durham, North Carolina, 27710

  • Local Institution - 0087

    Fort Lauderdale, Florida, 33308

  • Local Institution - 0115

    Fresno, California, 93703

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Local Institution - 0062

    Jacksonville, Florida, 32256

  • Local Institution - 0032

    Kansas City, Missouri, 64111-3220

  • Local Institution - 0086

    Kirkland, Washington, 98034

  • Local Institution - 0057

    Manchester, New Hampshire, 03103

  • Local Institution - 0207

    Milford, Massachusetts, 01757

  • Local Institution - 0014

    Mineola, New York, 11501

  • Local Institution - 0117

    New Orleans, Louisiana, 70121

  • Local Institution - 0072

    New York, New York, 10029

  • Local Institution - 0013

    Pittsburgh, Pennsylvania, 15212

  • Local Institution - 0104

    Portland, Oregon, 97213

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Local Institution - 0095

    St Louis, Missouri, 63110

  • Local Institution - 0033

    Thomasville, Georgia, 31792

Other trials in United States

China21 sites

  • Local Institution - 0171

    Beijing, Beijing Municipality, 100001

  • Local Institution - 0169

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0170

    Beijing, 100083

  • Local Institution - 0186

    Changchun, Jilin, 130021

  • Local Institution - 0184

    Chengdu, Sichuan, 610041

  • Local Institution - 0182

    Chongqing, Chongqing Municipality, 400030

  • Local Institution - 0217

    Guiyang, Guizhou, 550002

  • Local Institution - 0173

    Hangzhou, Zhejiang, 0

  • Local Institution - 0174

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0172

    Hangzhou, Zhejiang, 310014

  • Local Institution - 0219

    Harbin, Heilongjiang, 150000

  • Local Institution - 0175

    Nanjing, Jiangsu, 0

  • Local Institution - 0177

    Nanjing, Jiangsu, 210000

  • Local Institution - 0176

    Nanjing, Jiangsu, 210008

  • Local Institution - 0167

    Shanghai, Shanghai Municipality, 200025

  • Local Institution - 0162

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0163

    Shanghai, Shanghai Municipality, 200040

  • Local Institution - 0164

    Shanghai, 200032

  • Local Institution - 0220

    Taiyuan, Shan1xi, 030001

  • Local Institution - 0180

    Wuhan, Hubei, 430030

  • Local Institution - 0216

    Yantai, Shandong, 264000

Other trials in China

Japan20 sites

  • Local Institution - 0149

    Adachi-ku, Tokyo, 1168567

  • Local Institution - 0148

    Bunkyo-ku, Tokyo, 1138519

  • Local Institution - 0142

    Bunkyo-ku, Tokyo, 1138602

  • Local Institution - 0135

    Chiba, Chiba, 260-8717

  • Local Institution - 0140

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0201

    Hamamatasu, Shizuoka, 431-3192

  • Local Institution - 0136

    Hirosaki, Aomori, 036-8563

  • Local Institution - 0137

    Kita-Gun, Kagawa-ken, 7610793

  • Local Institution - 0147

    Matsuyama, Ehime, 7910280

  • Local Institution - 0214

    Morioka, Iwate, 0208505

  • Local Institution - 0141

    Niigata, Niigata, 9518520

  • Local Institution - 0143

    Okayama, Okayama-ken, 7008558

  • Local Institution - 0144

    Osaka, Osaka, 5418567

  • Local Institution - 0146

    Sapporo, Hokkaido, 0608543

  • Local Institution - 0139

    Sayama, Osaka, 589-8511

  • Local Institution - 0138

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution - 0145

    Takatsuki-shi, Osaka, 5698686

  • Local Institution - 0150

    Tsukuba, Ibaraki, 3058576

  • Local Institution - 0200

    Ube, Yamaguchi, 755-8505

  • Local Institution - 0215

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Germany11 sites

  • Local Institution - 0036

    Dresden, 01307

  • Local Institution - 0048

    Essen, 45147

  • Local Institution - 0047

    Freiburg im Breisgau, 79106

  • Local Institution - 0049

    Hamburg, 22763

  • Local Institution - 0037

    Hanover, 30625

  • Local Institution - 0041

    Jena, 07747

  • Local Institution - 0213

    Mannheim, 68167

  • Local Institution - 0038

    Nuremberg, 90419

  • Local Institution - 0040

    Tübingen, 72076

  • Local Institution - 0114

    Weiden, 92637

  • Local Institution - 0039

    Würzburg, 97080

Other trials in Germany

Brazil7 sites

  • Local Institution - 0018

    Barretos, São Paulo, 14784-400

  • Local Institution - 0017

    Brasília, Federal District, 70200-730

  • Local Institution - 0016

    Florianópolis, Santa Catarina, 88034-000

  • Local Institution - 0021

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0119

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Local Institution - 0020

    Porto Alegre, Rio Grande do Sul, 90610000

  • Local Institution - 0019

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

France7 sites

  • Local Institution - 0089

    Lille, 59000

  • Local Institution - 0088

    Marseille, 13273

  • Local Institution - 0091

    Nîmes, Gard, 30029

  • Local Institution - 0090

    Saint-Priest-en-Jarez, 42271

  • Local Institution - 0092

    Suresnes, 92151

  • Local Institution - 0093

    Tours, 37044

  • Local Institution - 0094

    Villejuif, 94805

Other trials in France

Spain7 sites

  • Local Institution - 0070

    A Coruña, 15006

  • Local Institution - 0068

    Barcelona, 08025

  • Local Institution - 0065

    Madrid, 28034

  • Local Institution - 0066

    Madrid, 28041

  • Local Institution - 0209

    Santander, 39008

  • Local Institution - 0067

    Seville, 41013

  • Local Institution - 0069

    Valencia, 46009

Other trials in Spain

Argentina6 sites

  • Local Institution - 0009

    Buenos Aires, 1120

  • Local Institution - 0005

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0134

    Córdoba, 5000

  • Local Institution - 0006

    Córdoba, 5004

  • Local Institution - 0007

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0008

    Viedma, 8500

Other trials in Argentina

Australia6 sites

  • Local Institution - 0100

    Doubleview, Western Australia, 6018

  • Local Institution - 0101

    Heidelberg, Victoria, 3084

  • Local Institution - 0188

    South Brisbane, Queensland, 4101

  • Local Institution - 0120

    Tugun, Queensland, 4224

  • Local Institution - 0096

    Waratah, New South Wales, 2298

  • Local Institution - 0099

    Westmead, New South Wales, 2145

Other trials in Australia

Italy6 sites

  • Local Institution - 0108

    Arezzo, 52100

  • Local Institution - 0197

    Faenza, 48018

  • Local Institution - 0111

    Forlì, 47014

  • Local Institution - 0109

    Grosseto, 58100

  • Local Institution - 0107

    Milan, 20133

  • Local Institution - 0110

    Naples, 80131

Other trials in Italy

South Korea6 sites

  • Local Institution - 0125

    Goyang-si, Gyeonggido, 10408

  • Local Institution - 0126

    Seongnam-si, 13620

  • Local Institution - 0124

    Seoul, 03080

  • Local Institution - 0151

    Seoul, 03722

  • Local Institution - 0128

    Seoul, 05505

  • Local Institution - 0127

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • Local Institution - 0156

    Kaohsiung City, 833

  • Local Institution - 0159

    Taichung, 40705

  • Local Institution - 0158

    Taipei, 100

  • Local Institution - 0155

    Taipei, 11217

  • Local Institution - 0157

    Taoyuan, 333

Other trials in Taiwan

Canada4 sites

  • Local Institution - 0053

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution - 0064

    London, Ontario, N6A 4L6

  • Local Institution - 0054

    Québec, Quebec, G1J 1Z4

  • Local Institution - 0052

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Mexico4 sites

  • Local Institution - 0129

    Mexico City, Mexico City, 06100

  • Local Institution - 0154

    Mexico City, Mexico City, 07760

  • Local Institution - 0131

    Monterrey, Nuevo León, 64460

  • Local Institution - 0130

    Tlalpan, Mexico City, 14080

Other trials in Mexico

Netherlands4 sites

  • Local Institution - 0022

    Amsterdam, North Holland, 1066 CX

  • Local Institution - 0055

    Enschede, 7512KZ

  • Local Institution - 0024

    Groningen, 9713 GZ

  • Local Institution - 0026

    Leeuwarden, 8934 AD

Other trials in Netherlands

Chile3 sites

  • Local Institution - 0010

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0012

    Viña del Mar, Valparaiso, 2520598

  • Local Institution - 0106

    Vitacura, 0

Other trials in Chile

Poland3 sites

  • Local Institution - 0189

    Bydgoszcz, 85-796

  • Local Institution - 0205

    Koszalin, 75-581

  • Local Institution - 0202

    Warsaw, 02-781

Other trials in Poland

Sweden3 sites

  • Local Institution - 0075

    Jönköping, 553 05

  • Local Institution - 0059

    Linköping, 581 85

  • Local Institution - 0058

    Lund, 221 85

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Local Institution - 0194

    Ankara, 06590

  • Local Institution - 0204

    Istanbul, 34300

  • Local Institution - 0193

    Izmir, 35340

Other trials in Turkey (Türkiye)

Czechia2 sites

  • Local Institution - 0160

    Brno, 656 53

  • Local Institution - 0152

    Hradec Králové, 500 05

Other trials in Czechia

Denmark2 sites

  • Local Institution - 0190

    Aalborg, 9210

  • Local Institution - 0196

    Herlev, 2730

Other trials in Denmark

Greece2 sites

  • Local Institution - 0102

    Athens, 115 28

  • Local Institution - 0103

    Ioannina, Ípeiros, 455 00

Other trials in Greece

Israel2 sites

  • Local Institution - 0199

    Kfar Saba, 44281

  • Local Institution - 0198

    Ramat Gan, 52621

Other trials in Israel

Norway2 sites

  • Local Institution - 0074

    Bergen, 5021

  • Local Institution - 0081

    Lorenskog, 1478

Other trials in Norway

Peru2 sites

  • Local Institution - 0031

    Lima, 15076

  • Local Institution - 0030

    Lima, 34

Other trials in Peru

Romania2 sites

  • Local Institution - 0191

    Cluj-Napoca, Cluj, 400015

  • Local Institution - 0187

    Craiova, Dolj, 200542

Other trials in Romania

Switzerland2 sites

  • Local Institution - 0061

    Baden, Canton of Aargau, 5404

  • Local Institution - 0042

    Chur, 7000

Other trials in Switzerland

Finland1 site

  • Local Institution - 0060

    Helsinki, 00029

Other trials in Finland

Russia1 site

  • Local Institution

    Moscow, 125367

Other trials in Russia

Singapore1 site

  • Local Institution - 0192

    Singapore, Central Singapore, 168583

Other trials in Singapore

About this study

Official title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called BMS-936558, Opdivo

    Specified Dose on Specified Days

  • IpilimumabBiological

    Also called BMS-734016, Yervoy

    Specified Dose on Specified Days

  • GemcitabineDrug

    Specified Dose on Specified Days

  • CisplatinDrug

    Specified Dose on Specified Days

  • CarboplatinDrug

    Specified Dose on Specified Days

Study groups in NCT03036098
Study groupRoleWhat they receive
Arm A: Investigational immunotherapyExperimentalNot described
Receives: Biological: Nivolumab; Biological: Ipilimumab
Arm B: Standard of care chemotherapyActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin
Arm C: Investigational immunotherapyExperimentalNot described
Receives: Biological: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin
Arm D: Standard of care chemotherapyActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study

    This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study.

    Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization.

    This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer.

    Measured: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

  2. Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study

    This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study.

    Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization.

    This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer.

    Measured: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

  3. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study

    This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing.

    Measured: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)

  4. Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study

    This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study.

    Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization.

    This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer.

    Measured: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

Secondary outcomes (8)

  1. Overall Survival (OS) in All Randomized Participants for Primary Study

    This measure looks at how long all participants live after being placed into a treatment group in the primary study.

    Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization.

    This helps to understand whether the treatment can help all participants in the study live longer.

    Measured: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

  2. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study

    This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing.

    Measured: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)

  3. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study

    This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing.

    Measured: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)

  4. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study

    This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group.

    Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check.

    This helps to understand whether the treatment can help participants live longer without their cancer progressing.

    Measured: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)

  5. Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study

    The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.

    Measured: At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192

  6. Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study

    The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.

    Measured: At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120

  7. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study

    This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test called immunohistochemistry or IHC) live without their cancer getting worse after being assigned to a treatment group in the sub-study.

    Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check.

    Measured: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)

  8. Overall Survival (OS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study

    This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the sub-study.

    Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization.

    This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer. The results are reviewed by independent experts who do not know which treatment each participant received, using standard criteria for measuring tumor response.

    Measured: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2017 (estimated)
  2. Study start24 Mar 2017
  3. Primary completion30 Aug 2024
  4. Study completion15 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03036098
Sponsor's protocol ID
CA209-901
Other IDs
2016-003881-14, 2016
Acronym
CheckMate901
Status last verified
Feb 2026
First submitted
27 Jan 2017
Last updated
6 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Tomita Y, Ye DW, Fujii A, Takeuchi N. Nivolumab plus gemcitabine-cisplatin for previously untreated unresectable or metastatic urothelial carcinoma: an Asian subgroup analysis from the global phase 3 CheckMate 901 trial. Urol Oncol. 2025 Dec;43(12):696.e9-696.e16. doi: 10.1016/j.urolonc.2025.08.022. Epub 2025 Sep 26.

    PubMed 41015742

  • van der Heijden MS, Sonpavde G, Powles T, Necchi A, Burotto M, Schenker M, Sade JP, Bamias A, Beuzeboc P, Bedke J, Oldenburg J, Chatta G, Urun Y, Ye D, He Z, Valderrama BP, Ku JH, Tomita Y, Filian J, Wang L, Purcea D, Patel MY, Nasroulah F, Galsky MD; CheckMate 901 Trial Investigators. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. N Engl J Med. 2023 Nov 9;389(19):1778-1789. doi: 10.1056/NEJMoa2309863. Epub 2023 Oct 22.

    PubMed 37870949

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Gemcitabine in people with Urothelial Cancer, run by Bristol-Myers Squibb at 174 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States, China, Japan, Germany, Brazil and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study (time frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036098, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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