AzTrials
AzTrials

Carcinoma, Renal CellPhase 3CheckMate 914NCT03138512

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

A Phase 3 study testing nivolumab and ipilimumab in people with Carcinoma, Renal Cell, run by Bristol-Myers Squibb at 200 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
nivolumab and ipilimumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,641 participants
Where
200 sitesin 25 countries
Study dates
7 Jul 2017to 1 Feb 2024
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

  • Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
  • Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
  • Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
  • Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Women must agree to follow methods of contraception, if applicable

Who cannot join

  • Participants with an active known or suspected autoimmune disease
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
  • History of allergy or hypersensitivity to study drug components
  • Participants with a condition requiring systemic treatment with corticosteroids
  • Participants who have received a live/attenuated vaccine within 30 days of first treatment
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

200 sites in 25 countries.

200 sites in 25 countries

China24 sites

  • Local Institution - 0147

    Beijing, Beijing Municipality, 100032

  • Local Institution - 0153

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0159

    Beijing, Beijing Municipality, 100853

  • Local Institution - 0145

    Changchun, Jilin, 130021

  • Local Institution - 0142

    Chengdu, Sichuan, 610041

  • Local Institution - 0143

    Chengdu, Sichuan, 610072

  • Local Institution - 0132

    Fuzhou, Fujian, 350001

  • Local Institution - 0141

    Guangzhou, Guangdong, 510120

  • Local Institution - 0134

    Guangzhou, 0

  • Local Institution - 0157

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0131

    Hangzhou, Zhejiang, 310014

  • Local Institution - 0140

    Nanchang, Jiangxi, 0

  • Local Institution - 0138

    Nanjing, Jiangsu, 210029

  • Local Institution - 0139

    Nanjing, 210008

  • Local Institution - 0137

    Shanghai, Shanghai Municipality, 200025

  • Local Institution - 0166

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0152

    Shanghai, Shanghai Municipality, 200040

  • Local Institution - 0148

    Shanghai, Shanghai Municipality, 200433

  • Local Institution - 0176

    Shanghai, 200032

  • Local Institution - 0175

    Tianjin, Tianjin Municipality, 300222

  • Local Institution - 0194

    Wuhan, Hebei, 430030

  • Local Institution - 0133

    Wuhan, Hubei, 430061

  • Local Institution - 0144

    Xi'an, Shan3xi, 710061

  • Local Institution - 0146

    Yantai, Shandong, 264000

Other trials in China

Japan24 sites

  • Local Institution - 0188

    Adachi-ku, Tokyo, 1230872

  • Local Institution - 0189

    Bunkyo-ku, Tokyo, 113-8510

  • Local Institution - 0119

    Bunkyo-ku, Tokyo, 1138603

  • Local Institution - 0158

    Chiba, Chiba, 260-8717

  • Local Institution - 0121

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0193

    Hirosaki-shi, Aomori, 0368563

  • Local Institution - 0165

    Hiroshima, 734-8551

  • Local Institution - 0130

    Kamigyō-ku, Kyoto, 602-8566

  • Local Institution - 0167

    Kobe, Hyōgo, 6500017

  • Local Institution - 0216

    Kumamoto, Kumamoto, 860-0811

  • Local Institution - 0123

    Nagasaki, Nagasaki, 8528102

  • Local Institution - 0120

    Niigata, Niigata, 9518520

  • Local Institution - 0125

    Osakasayama-shi, Osaka, 5898511

  • Local Institution - 0156

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0149

    Shinjuku-ku, Tokyo, 1608582

  • Local Institution - 0168

    Shiwa-gun, Iwate, 0283695

  • Local Institution - 0122

    Suita-shi, Osaka, 565-0871

  • Local Institution - 0162

    Tokushima, Tokushima, 770-8503

  • Local Institution - 0129

    Toyoake Shi, Aichi-ken, 4701192

  • Local Institution - 0191

    Tsukuba, Ibaraki, 3058576

  • Local Institution - 0163

    Ube-shi, Yamaguchi, 7558505

  • Local Institution - 0192

    Wakayama, 641-8510

  • Local Institution - 0127

    Yamagata, 990-9585

  • Local Institution - 0128

    Yokohama, Kanagawa, 2360004

Other trials in Japan

United States21 sites

  • Local Institution - 0010

    Allentown, Pennsylvania, 18103

  • Local Institution - 0016

    Athens, Georgia, 30607

  • Local Institution - 0185

    Aurora, Colorado, 80045

  • Local Institution - 0019

    Birmingham, Alabama, 35205

  • Local Institution - 0007

    Buffalo, New York, 14263

  • Local Institution - 0013

    Chattanooga, Tennessee, 37404

  • Local Institution - 0005

    Chicago, Illinois, 60611

  • Local Institution

    Chicago, Illinois, 60612

  • Local Institution - 0008

    Columbus, Ohio, 43210

  • Local Institution - 0057

    Fairfax, Virginia, 22031

  • Local Institution - 0014

    Greenville, South Carolina, 29607

  • Local Institution - 0012

    Howell Township, New Jersey, 07731

  • Local Institution - 0186

    Los Angeles, California, 90048

  • Local Institution - 0180

    Los Angeles, California, 90095

  • Local Institution - 0183

    Nashville, Tennessee, 37212

  • Local Institution - 0181

    New York, New York, 10029

  • Local Institution - 0001

    New York, New York, 10065

  • Local Institution - 0009

    Portland, Oregon, 97213

  • Local Institution - 0002

    San Francisco, California, 94115

  • Local Institution - 0056

    Springdale, Arkansas, 72762

  • Local Institution - 0006

    St Louis, Missouri, 63110

Other trials in United States

Argentina13 sites

  • Local Institution - 0232

    Bariloche, Río Negro Province, 0

  • Local Institution - 0179

    Buenos Aires, C1419AHN

  • Local Institution - 0099

    CABA, 1199

  • Local Institution - 0178

    Capital Federal, Buenos Aires, 1280

  • Local Institution - 0126

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425

  • Local Institution - 0203

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426

  • Local Institution - 0096

    Córdoba, 5000

  • Local Institution - 0098

    Córdoba, X5004FHP

  • Local Institution - 0095

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0208

    Mar del Plata, Buenos Aires, B7600FZO

  • Local Institution - 0173

    Río Cuarto, Córdoba Province, 5800

  • Local Institution - 0164

    San Juan, 5402

  • Local Institution - 0097

    San Miguel de Tucumán, 4000

Other trials in Argentina

France12 sites

  • Local Institution - 0083

    Besançon, 25030

  • Local Institution - 0080

    Bordeaux, 33000

  • Local Institution - 0082

    La Roche-sur-Yon, 85925

  • Local Institution - 0116

    Lyon, 69373

  • Local Institution - 0079

    Marseille, 13273

  • Local Institution - 0198

    Paris, 75015

  • Local Institution - 0081

    Rennes, 35042

  • Local Institution - 0077

    Strasbourg, 67200

  • Local Institution - 0115

    Toulouse, 31059

  • Local Institution - 0150

    Tours, 37044

  • Local Institution - 0078

    Vandœuvre-lès-Nancy, 54511

  • Local Institution - 0076

    Villejuif, 94800

Other trials in France

Germany11 sites

  • Local Institution - 0053

    Aachen, 52074

  • Local Institution - 0103

    Essen, 45147

  • Local Institution - 0052

    Hamburg, 22763

  • Local Institution - 0231

    Hanover, 30559

  • Local Institution - 0061

    Hanover, 30625

  • Local Institution - 0062

    Jena, 07747

  • Local Institution - 0102

    Munich, 81377

  • Local Institution - 0054

    Nuremberg, 90419

  • Local Institution - 0055

    Rostock, 18057

  • Local Institution - 0217

    Tübingen, Baden-Wurttemberg, 72076

  • Local Institution - 0101

    Würzburg, 97080

Other trials in Germany

Mexico11 sites

  • Local Institution - 0089

    Chihuahua City, 31000

  • Local Institution - 0104

    Mazatlán, Sinaloa, 82110

  • Local Institution - 0196

    Mérida, Yucatán, 97070

  • Local Institution - 0151

    Mexico City, Mexico City, 03100

  • Local Institution - 0088

    Monterrey, NL, 64060

  • Local Institution - 0169

    San Luis Potosí City, 78250

  • Local Institution - 0242

    Tijuana, Estado de Baja California, 22010

  • Local Institution - 0111

    Tlalpan, Mexico City, 14080

  • Local Institution - 0195

    Torreón, Coahuila, 27010

  • Local Institution - 0197

    Tuxtla Gutiérrez, Chiapas, 29090

  • Local Institution - 0110

    Zapopan, Jalisco, 45030

Other trials in Mexico

Australia10 sites

  • Local Institution - 0033

    Clayton, Victoria, 0

  • Local Institution - 0034

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0214

    Heidelberg, Victoria, 3084

  • Local Institution - 0215

    Macquarie Park, New South Wales, 2109

  • Local Institution - 0031

    Murdoch, Western Australia, 6150

  • Local Institution - 0032

    Northmead, New South Wales, 2152

  • Local Institution - 0036

    Randwick, New South Wales, 2031

  • Local Institution - 0113

    South Brisbane, Queensland, 4101

  • Local Institution - 0213

    Southport, Queensland, 4215

  • Local Institution - 0035

    St Leonards, New South Wales, 2065

Other trials in Australia

Spain9 sites

  • Local Institution - 0204

    Barcelona, 08035

  • Local Institution - 0206

    Barcelona, 08036

  • Local Institution - 0124

    Cáceres, 10003

  • Local Institution - 0207

    Córdoba, 14004

  • Local Institution - 0118

    Lugo, 27003

  • Local Institution - 0114

    Madrid, 28034

  • Local Institution - 0205

    Madrid, 28041

  • Local Institution - 0117

    Sabadell, 08208

  • Local Institution - 0161

    Seville, 41013

Other trials in Spain

Brazil8 sites

  • Local Institution - 0043

    Barretos, São Paulo, 14780-070

  • Local Institution - 0045

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0047

    Brasília, Federal District, 70200-730

  • Local Institution - 0046

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0048

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0160

    Rio de Janeiro, 20775-001

  • Local Institution - 0044

    São Paulo, São Paulo, 05652-900

  • Local Institution - 0050

    São Paulo, 01246000

Other trials in Brazil

Canada6 sites

  • Local Institution - 0042

    Montreal, Quebec, H2X 0C1

  • Local Institution - 0087

    Oshawa, Ontario, L1G 2B9

  • Local Institution - 0040

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0086

    Saint John, New Brunswick, E2L 3L6

  • Local Institution - 0112

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0041

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy6 sites

  • Local Institution - 0105

    Arezzo, 52100

  • Local Institution - 0172

    Cremona, 26100

  • Local Institution - 0106

    Naples, 80131

  • Local Institution - 0107

    Parma, 43100

  • Local Institution - 0109

    Roma, 00168

  • Local Institution - 0108

    Verona, 37134

Other trials in Italy

Chile5 sites

  • Local Institution - 0223

    La Serena, Coquimbo Region, 1720430

  • Local Institution - 0246

    Santiago, Santiago Metropolitan, 0

  • Local Institution

    Santiago, Santiago Metropolitan, 7500713

  • Local Institution - 0221

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0222

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Colombia5 sites

  • Local Institution - 0229

    Bogotá, 111511

  • Local Institution - 0230

    Floridablanca, 0

  • Local Institution - 0227

    Medellín, Antioquia, 050034

  • Local Institution - 0226

    Pereira, 99999

  • Local Institution - 0228

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Romania5 sites

  • Local Institution - 0243

    Bucharest, 022328

  • Local Institution - 0200

    Cluj-Napoca, 400015

  • Local Institution - 0247

    Cluj-Napoca, 400015

  • Local Institution - 0199

    Craiova, 200542

  • Local Institution - 0202

    Iași, 700483

Other trials in Romania

United Kingdom5 sites

  • Local Institution - 0063

    Manchester, M20 4BX

  • Local Institution - 0071

    Northwood, HA6 2RN

  • Local Institution - 0073

    Preston, PR2 9HT

  • Local Institution - 0075

    Southampton, Hampshire, SO16 6YD

  • Local Institution - 0072

    Swansea, SA2 8QA

Other trials in United Kingdom

Belgium4 sites

  • Local Institution - 0064

    Anderlecht, 1070

  • Local Institution - 0058

    Ghent, Oost-Vlaanderen, 9000

  • Local Institution - 0060

    Hasselt, 3500

  • Local Institution - 0059

    Liège, 4000

Other trials in Belgium

Russia4 sites

  • Local Institution - 0065

    Moscow, 117997

  • Local Institution - 0170

    Novosibirsk, 630099

  • Local Institution - 0171

    Saint Petersburg, 194044

  • Local Institution - 0021

    Saint Petersburg, 198255

Other trials in Russia

Netherlands3 sites

  • Local Institution - 0066

    Amsterdam, 1066 CX

  • Local Institution - 0067

    Rotterdam, 3008 AE

  • Local Institution - 0092

    Zwolle, 8025 AB

Other trials in Netherlands

Switzerland3 sites

  • Local Institution - 0218

    Chur, 7000

  • Local Institution - 0219

    Sankt Gallen, 9007

  • Local Institution - 0225

    Zurich, 8091

Other trials in Switzerland

Turkey (Türkiye)3 sites

  • Local Institution - 0209

    Ankara, 06590

  • Local Institution - 0210

    Istanbul, 34098

  • Local Institution

    Istanbul, 34214

Other trials in Turkey (Türkiye)

Austria2 sites

  • Local Institution - 0068

    Linz, 4020

  • Local Institution - 0084

    Vienna, 1160

Other trials in Austria

Czechia2 sites

  • Local Institution - 0094

    Hradec Králové, 500 05

  • Local Institution - 0025

    Olomouc, 779 00

Other trials in Czechia

Poland2 sites

  • Local Institution - 0155

    Bydgoszcz, 85-796

  • Local Institution - 0038

    Wroclaw, 53-413

Other trials in Poland

Singapore2 sites

  • Local Institution - 0018

    Singapore, Central Singapore, 168583

  • Local Institution - 0017

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Read the detailed description

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Being tested
nivolumab, ipilimumab, nivolumab placebo, ipilimumab placebo
Keywords
localized, resected, adjuvant, Renal Cell Carcinoma, Kidney Cancer, Nephrectomy, Clear cell, High Risk of Relapse/Recurrence
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Recurrence

What participants receive

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

  • nivolumabBiological

    Also called Opdivo

    Specified dose on specified days

  • ipilimumabBiological

    Also called Yervoy

    Specified dose on specified days

  • nivolumab placeboDrug

    Specified dose on specified days

  • ipilimumab placeboDrug

    Specified dose on specified days

Study groups in NCT03138512
Study groupRoleWhat they receive
Part A, Arm A: nivolumab + ipilimumabExperimentalNot described
Receives: Biological: nivolumab; Biological: ipilimumab
Part A, Arm B: nivolumab placebo + ipilimumab placeboPlacebo comparatorNot described
Receives: Drug: nivolumab placebo; Drug: ipilimumab placebo
Part B, Arm A: nivolumab + ipilimumabExperimentalNot described
Receives: Biological: nivolumab; Biological: ipilimumab
Part B, Arm B: nivolumab placebo + ipilimumab placeboPlacebo comparatorNot described
Receives: Drug: nivolumab placebo; Drug: ipilimumab placebo
Part B, Arm C: nivolumab + ipilimumab placeboExperimentalNot described
Receives: Biological: nivolumab; Drug: ipilimumab placebo

What is being measured

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

  1. Disease-Free Survival (DFS) by BICR - Treatment Part A and B

    Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.

    Measured: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Secondary outcomes (12)

  1. Overall Survival (OS) - Treatment Part A and B

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.

    Measured: From randomization to the date of death (up to approximately 72 months)

  2. Overall Survival (OS) Rate (5 Years) - Treatment Part A and B

    Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.

    Measured: At 5 years

  3. Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B

    Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.

    Measured: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

  4. Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates

    Measured: From randomization to the date of death (up to approximately 72 months)

  5. The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

    Measured: From first dose to 30 days post last dose (up to approximately 40 weeks)

  6. The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

    Measured: From first dose to 30 days post last dose (up to approximately 40 weeks)

  7. The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

    Measured: From first dose to 100 days post last dose (up to approximately 50 weeks)

  8. The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

    Measured: From first dose to 100 days post last dose (up to approximately 50 weeks)

  9. The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A

    Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.

    Measured: From first dose to 30 days post last dose (up to approximately 40 weeks)

  10. The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B

    Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.

    Measured: From first dose to 30 days post last dose (up to approximately 40 weeks)

  11. The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A

    Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.

    Measured: From first dose to 100 days post last dose (up to approximately 50 weeks)

  12. The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B

    Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.

    Measured: From first dose to 100 days post last dose (up to approximately 50 weeks)

Timeline

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

  1. First posted3 May 2017
  2. Study start7 Jul 2017
  3. Primary completion28 Sep 2023
  4. Study completion1 Feb 2024

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,641 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03138512
Sponsor's protocol ID
CA209-914
Other IDs
2016-004502-34, 2016
Acronym
CheckMate 914
Status last verified
Nov 2024
First submitted
1 May 2017
Last updated
18 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Motzer RJ, Bex A, Russo P, Tomita Y, Cutuli HJ, Rojas C, Gross-Goupil M, Schinzari G, Melichar B, Barthelemy P, Ruiz Garcia A, Sosman J, Grimm MO, Goh JC, Suarez C, Kollmannsberger CK, Nair SG, Shuch BM, Huang J, Simsek B, Spiridigliozzi J, Lee CW, van Kooten Losio M, Grunwald V. Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial. J Clin Oncol. 2025 Jan 10;43(2):189-200. doi: 10.1200/JCO.24.00773. Epub 2024 Sep 20.

    PubMed 39303200

  • Motzer RJ, Russo P, Grunwald V, Tomita Y, Zurawski B, Parikh O, Buti S, Barthelemy P, Goh JC, Ye D, Lingua A, Lattouf JB, Albiges L, George S, Shuch B, Sosman J, Staehler M, Vazquez Estevez S, Simsek B, Spiridigliozzi J, Chudnovsky A, Bex A. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023 Mar 11;401(10379):821-832. doi: 10.1016/S0140-6736(22)02574-0. Epub 2023 Feb 9.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nivolumab and ipilimumab in people with Carcinoma, Renal Cell, run by Bristol-Myers Squibb at 200 sites in 25 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in China, Japan, United States, Argentina, France and 20 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. Some participants in this study may receive a placebo. 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 Dec 2024). 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?

Disease-Free Survival (DFS) by BICR - Treatment Part A and B (time frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)). 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 NCT03138512, which also lists 3 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 18 Dec 2024.

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