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

NCT03138512 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-9142016-004502-34
• Study Type: interventional
• Target: 1,641
• Locations: 24 countries
• Sites: 190

Brief 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.

Conditions

Carcinoma, Renal Cell

Keywords

localized; resected; adjuvant; Renal Cell Carcinoma; Kidney Cancer; Nephrectomy; Clear cell; High Risk of Relapse/Recurrence

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (12)

• Overall Survival (OS) - Treatment Part A and B

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

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

  At 5 years

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

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

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

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

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

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

Study Arms (5)

Part A, Arm A: nivolumab + ipilimumab

EXPERIMENTAL

Biological: nivolumab; Biological: ipilimumab

Part A, Arm B: nivolumab placebo + ipilimumab placebo

PLACEBO COMPARATOR

Drug: nivolumab placebo; Drug: ipilimumab placebo

Part B, Arm A: nivolumab + ipilimumab

EXPERIMENTAL

Biological: nivolumab; Biological: ipilimumab

Part B, Arm B: nivolumab placebo + ipilimumab placebo

PLACEBO COMPARATOR

Drug: nivolumab placebo; Drug: ipilimumab placebo

Part B, Arm C: nivolumab + ipilimumab placebo

EXPERIMENTAL

Biological: nivolumab; Drug: ipilimumab placebo

Interventions

nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo

Part A, Arm A: nivolumab + ipilimumab; Part B, Arm A: nivolumab + ipilimumab; Part B, Arm C: nivolumab + ipilimumab placebo

ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: Yervoy

Part A, Arm A: nivolumab + ipilimumab; Part B, Arm A: nivolumab + ipilimumab

nivolumab placebo DRUG

Specified dose on specified days

Part A, Arm B: nivolumab placebo + ipilimumab placebo; Part B, Arm B: nivolumab placebo + ipilimumab placebo

ipilimumab placebo DRUG

Specified dose on specified days

Part A, Arm B: nivolumab placebo + ipilimumab placebo; Part B, Arm B: nivolumab placebo + ipilimumab placebo; Part B, Arm C: nivolumab + ipilimumab placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (200)

Local Institution - 0019

Birmingham, Alabama, 35205, United States

Location

Local Institution - 0056

Springdale, Arkansas, 72762, United States

Location

Local Institution - 0186

Los Angeles, California, 90048, United States

Location

Local Institution - 0180

Los Angeles, California, 90095, United States

Location

Local Institution - 0002

San Francisco, California, 94115, United States

Location

Local Institution - 0185

Aurora, Colorado, 80045, United States

Location

Local Institution - 0016

Athens, Georgia, 30607, United States

Location

Local Institution - 0005

Chicago, Illinois, 60611, United States

Location

Local Institution

Chicago, Illinois, 60612, United States

Location

Local Institution - 0006

St Louis, Missouri, 63110, United States

Location

Local Institution - 0012

Howell Township, New Jersey, 07731, United States

Location

Local Institution - 0007

Buffalo, New York, 14263, United States

Location

Local Institution - 0181

New York, New York, 10029, United States

Location

Local Institution - 0001

New York, New York, 10065, United States

Location

Local Institution - 0008

Columbus, Ohio, 43210, United States

Location

Local Institution - 0009

Portland, Oregon, 97213, United States

Location

Local Institution - 0010

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0014

Greenville, South Carolina, 29607, United States

Location

Local Institution - 0013

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0183

Nashville, Tennessee, 37212, United States

Location

Local Institution - 0057

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0178

Capital Federal, Buenos Aires, 1280, Argentina

Location

Local Institution - 0126

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425, Argentina

Location

Local Institution - 0203

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426, Argentina

Location

Local Institution - 0095

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Local Institution - 0208

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Local Institution - 0173

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0232

Bariloche, Río Negro Province, 0, Argentina

Location

Local Institution - 0179

Buenos Aires, C1419AHN, Argentina

Location

Local Institution - 0099

CABA, 1199, Argentina

Location

Local Institution - 0096

Córdoba, 5000, Argentina

Location

Local Institution - 0098

Córdoba, X5004FHP, Argentina

Location

Local Institution - 0164

San Juan, 5402, Argentina

Location

Local Institution - 0097

San Miguel de Tucumán, 4000, Argentina

Location

Local Institution - 0215

Macquarie Park, New South Wales, 2109, Australia

Location

Local Institution - 0032

Northmead, New South Wales, 2152, Australia

Location

Local Institution - 0036

Randwick, New South Wales, 2031, Australia

Location

Local Institution - 0035

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0113

South Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0213

Southport, Queensland, 4215, Australia

Location

Local Institution - 0034

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0033

Clayton, Victoria, 0, Australia

Location

Local Institution - 0214

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0031

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0068

Linz, 4020, Austria

Location

Local Institution - 0084

Vienna, 1160, Austria

Location

Local Institution - 0058

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Local Institution - 0064

Anderlecht, 1070, Belgium

Location

Local Institution - 0060

Hasselt, 3500, Belgium

Location

Local Institution - 0059

Liège, 4000, Belgium

Location

Local Institution - 0047

Brasília, Federal District, 70200-730, Brazil

Location

Local Institution - 0045

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0046

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0048

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0043

Barretos, São Paulo, 14780-070, Brazil

Location

Local Institution - 0044

São Paulo, São Paulo, 05652-900, Brazil

Location

Local Institution - 0160

Rio de Janeiro, 20775-001, Brazil

Location

Local Institution - 0050

São Paulo, 01246000, Brazil

Location

Local Institution - 0041

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0086

Saint John, New Brunswick, E2L 3L6, Canada

Location

Local Institution - 0087

Oshawa, Ontario, L1G 2B9, Canada

Location

Local Institution - 0112

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0042

Montreal, Quebec, H2X 0C1, Canada

Location

Local Institution - 0040

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0223

La Serena, Coquimbo Region, 1720430, Chile

Location

Local Institution - 0222

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0246

Santiago, Santiago Metropolitan, 0, Chile

Location

Local Institution

Santiago, Santiago Metropolitan, 7500713, Chile

Location

Local Institution - 0221

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0147

Beijing, Beijing Municipality, 100032, China

Location

Local Institution - 0153

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0159

Beijing, Beijing Municipality, 100853, China

Location

Local Institution - 0132

Fuzhou, Fujian, 350001, China

Location

Local Institution - 0141

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0194

Wuhan, Hebei, 430030, China

Location

Local Institution - 0133

Wuhan, Hubei, 430061, China

Location

Local Institution - 0138

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0140

Nanchang, Jiangxi, 0, China

Location

Local Institution - 0145

Changchun, Jilin, 130021, China

Location

Local Institution - 0144

Xi'an, Shan3xi, 710061, China

Location

Local Institution - 0146

Yantai, Shandong, 264000, China

Location

Local Institution - 0137

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0166

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0152

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution - 0148

Shanghai, Shanghai Municipality, 200433, China

Location

Local Institution - 0142

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0143

Chengdu, Sichuan, 610072, China

Location

Local Institution - 0175

Tianjin, Tianjin Municipality, 300222, China

Location

Local Institution - 0157

Hangzhou, Zhejiang, 310009, China

Location

Local Institution - 0131

Hangzhou, Zhejiang, 310014, China

Location

Local Institution - 0134

Guangzhou, 0, China

Location

Local Institution - 0139

Nanjing, 210008, China

Location

Local Institution - 0176

Shanghai, 200032, China

Location

Local Institution - 0227

Medellín, Antioquia, 050034, Colombia

Location

Local Institution - 0228

Valledupar, Cesar Department, 200001, Colombia

Location

Local Institution - 0229

Bogotá, 111511, Colombia

Location

Local Institution - 0230

Floridablanca, 0, Colombia

Location

Local Institution - 0226

Pereira, 99999, Colombia

Location

Local Institution - 0094

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0025

Olomouc, 779 00, Czechia

Location

Local Institution - 0083

Besançon, 25030, France

Location

Local Institution - 0080

Bordeaux, 33000, France

Location

Local Institution - 0082

La Roche-sur-Yon, 85925, France

Location

Local Institution - 0116

Lyon, 69373, France

Location

Local Institution - 0079

Marseille, 13273, France

Location

Local Institution - 0198

Paris, 75015, France

Location

Local Institution - 0081

Rennes, 35042, France

Location

Local Institution - 0077

Strasbourg, 67200, France

Location

Local Institution - 0115

Toulouse, 31059, France

Location

Local Institution - 0150

Tours, 37044, France

Location

Local Institution - 0078

Vandœuvre-lès-Nancy, 54511, France

Location

Local Institution - 0076

Villejuif, 94800, France

Location

Local Institution - 0217

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Institution - 0053

Aachen, 52074, Germany

Location

Local Institution - 0103

Essen, 45147, Germany

Location

Local Institution - 0052

Hamburg, 22763, Germany

Location

Local Institution - 0231

Hanover, 30559, Germany

Location

Local Institution - 0061

Hanover, 30625, Germany

Location

Local Institution - 0062

Jena, 07747, Germany

Location

Local Institution - 0102

Munich, 81377, Germany

Location

Local Institution - 0054

Nuremberg, 90419, Germany

Location

Local Institution - 0055

Rostock, 18057, Germany

Location

Local Institution - 0101

Würzburg, 97080, Germany

Location

Local Institution - 0105

Arezzo, 52100, Italy

Location

Local Institution - 0172

Cremona, 26100, Italy

Location

Local Institution - 0106

Napoli, 80131, Italy

Location

Local Institution - 0107

Parma, 43100, Italy

Location

Local Institution - 0109

Roma, 00168, Italy

Location

Local Institution - 0108

Verona, 37134, Italy

Location

Local Institution - 0129

Toyoake Shi, Aichi-ken, 4701192, Japan

Location

Local Institution - 0193

Hirosaki-shi, Aomori, 0368563, Japan

Location

Local Institution - 0158

Chiba, Chiba, 260-8717, Japan

Location

Local Institution - 0121

Fukuoka, Fukuoka, 8128582, Japan

Location

Local Institution - 0156

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0167

Kobe, Hyōgo, 6500017, Japan

Location

Local Institution - 0191

Tsukuba, Ibaraki, 3058576, Japan

Location

Local Institution - 0168

Shiwa-gun, Iwate, 0283695, Japan

Location

Local Institution - 0128

Yokohama, Kanagawa, 2360004, Japan

Location

Local Institution - 0216

Kumamoto, Kumamoto, 860-0811, Japan

Location

Local Institution - 0130

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

Local Institution - 0123

Nagasaki, Nagasaki, 8528102, Japan

Location

Local Institution - 0120

Niigata, Niigata, 9518520, Japan

Location

Local Institution - 0125

Osakasayama-shi, Osaka, 5898511, Japan

Location

Local Institution - 0122

Suita-shi, Osaka, 565-0871, Japan

Location

Local Institution - 0162

Tokushima, Tokushima, 770-8503, Japan

Location

Local Institution - 0188

Adachi-ku, Tokyo, 1230872, Japan

Location

Local Institution - 0189

Bunkyo-ku, Tokyo, 113-8510, Japan

Location

Local Institution - 0119

Bunkyo-ku, Tokyo, 1138603, Japan

Location

Local Institution - 0149

Shinjuku-ku, Tokyo, 1608582, Japan

Location

Local Institution - 0163

Ube-shi, Yamaguchi, 7558505, Japan

Location

Local Institution - 0165

Hiroshima, 734-8551, Japan

Location

Local Institution - 0192

Wakayama, 641-8510, Japan

Location

Local Institution - 0127

Yamagata, 990-9585, Japan

Location

Local Institution - 0197

Tuxtla Gutiérrez, Chiapas, 29090, Mexico

Location

Local Institution - 0195

Torreón, Coahuila, 27010, Mexico

Location

Local Institution - 0242

Tijuana, Estado de Baja California, 22010, Mexico

Location

Local Institution - 0110

Zapopan, Jalisco, 45030, Mexico

Location

Local Institution - 0151

Mexico City, Mexico City, 03100, Mexico

Location

Local Institution - 0111

Tlalpan, Mexico City, 14080, Mexico

Location

Local Institution - 0104

Mazatlán, Sinaloa, 82110, Mexico

Location

Local Institution - 0196

Mérida, Yucatán, 97070, Mexico

Location

Local Institution - 0089

Chihuahua City, 31000, Mexico

Location

Local Institution - 0088

Monterrey, NL, 64060, Mexico

Location

Local Institution - 0169

San Luis Potosí City, 78250, Mexico

Location

Local Institution - 0066

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0067

Rotterdam, 3008 AE, Netherlands

Location

Local Institution - 0092

Zwolle, 8025 AB, Netherlands

Location

Local Institution - 0155

Bydgoszcz, 85-796, Poland

Location

Local Institution - 0038

Wroclaw, 53-413, Poland

Location

Local Institution - 0243

Bucharest, 022328, Romania

Location

Local Institution - 0200

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0247

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0199

Craiova, 200542, Romania

Location

Local Institution - 0202

Iași, 700483, Romania

Location

Local Institution - 0065

Moscow, 117997, Russia

Location

Local Institution - 0170

Novosibirsk, 630099, Russia

Location

Local Institution - 0171

Saint Petersburg, 194044, Russia

Location

Local Institution - 0021

Saint Petersburg, 198255, Russia

Location

Local Institution - 0018

Singapore, Central Singapore, 168583, Singapore

Location

Local Institution - 0017

Singapore, 119074, Singapore

Location

Local Institution - 0204

Barcelona, 08035, Spain

Location

Local Institution - 0206

Barcelona, 08036, Spain

Location

Local Institution - 0124

Cáceres, 10003, Spain

Location

Local Institution - 0207

Córdoba, 14004, Spain

Location

Local Institution - 0118

Lugo, 27003, Spain

Location

Local Institution - 0114

Madrid, 28034, Spain

Location

Local Institution - 0205

Madrid, 28041, Spain

Location

Local Institution - 0117

Sabadell, 08208, Spain

Location

Local Institution - 0161

Seville, 41013, Spain

Location

Local Institution - 0218

Chur, 7000, Switzerland

Location

Local Institution - 0219

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0225

Zurich, 8091, Switzerland

Location

Local Institution - 0209

Ankara, 06590, Turkey (Türkiye)

Location

Local Institution - 0210

Istanbul, 34098, Turkey (Türkiye)

Location

Local Institution

Istanbul, 34214, Turkey (Türkiye)

Location

Local Institution - 0075

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0063

Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0071

Northwood, HA6 2RN, United Kingdom

Location

Local Institution - 0073

Preston, PR2 9HT, United Kingdom

Location

Local Institution - 0072

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39303200 DERIVED

• 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.

  PMID: 36774933 DERIVED

• Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

  PMID: 33526329 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Recurrence

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: July 7, 2017
• Primary Completion: September 28, 2023
• Study Completion: February 1, 2024
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (24); AR (13); AU (2); PL (2); SG (2); CO (5); JP (24); RO (5); CH (3); RU (4); TU (3); GB (5); DE (11); BR (8); US (21); BE (4); FR (12); NL (3); ME (11); ES (9); CL (5); CA (6); IT (6); CZ (2)