AzTrials
AzTrials

Lung CancerPhase 3CheckMate 451NCT02538666

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

A Phase 3 study testing Nivolumab and Ipilimumab in people with Lung Cancer, run by Bristol-Myers Squibb at 197 sites in 32 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

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Nivolumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
907 participants
Where
197 sitesin 32 countries
Study dates
13 Oct 2015to 11 Nov 2021
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

  • Subjects with histologically or cytologically confirmed extensive stage disease SCLC
  • Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Who cannot join

  • Subjects with symptomatic Central Nervous System (CNS) metastases
  • Subjects receiving consolidative chest radiation
  • Subjects with active, known, or suspected autoimmune disease are excluded
  • All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

197 sites in 32 countries.

197 sites in 32 countries

United States28 sites

  • Local Institution - 0004

    Allentown, Pennsylvania, 18103

  • Local Institution - 0010

    Atlanta, Georgia, 30322

  • Local Institution - 0051

    Baltimore, Maryland, 21287

  • Local Institution - 0107

    Boston, Massachusetts, 02215

  • Local Institution - 0207

    Boston, Massachusetts, 02215

  • Local Institution - 0005

    Charleston, South Carolina, 29425

  • Local Institution - 0129

    Cincinnati, Ohio, 45242

  • Local Institution - 0009

    Columbus, Ohio, 43210

  • Local Institution - 0014

    Durham, North Carolina, 27710

  • Local Institution - 0061

    Fairway, Kansas, 66205

  • Local Institution - 0215

    Fargo, North Dakota, 58102

  • Local Institution - 0127

    Fort Myers, Florida, 33901

  • Local Institution - 0013

    Indianapolis, Indiana, 46237

  • Local Institution - 0007

    Jacksonville, Florida, 32256

  • Local Institution - 0032

    Lexington, Kentucky, 40503

  • Local Institution - 0202

    New Haven, Connecticut, 06520

  • Local Institution - 0008

    New York, New York, 10065

  • Local Institution - 0001

    Portland, Oregon, 97213

  • Local Institution - 0034

    Portland, Oregon, 97239

  • Local Institution - 0006

    Richmond, Virginia, 23226

  • Local Institution - 0003

    Sacramento, California, 95816

  • Local Institution - 0011

    Salt Lake City, Utah, 84112

  • Local Institution - 0002

    Sayre, Pennsylvania, 18840

  • Local Institution - 0213

    Sioux Falls, South Dakota, 57104

  • Local Institution - 0015

    St Louis, Missouri, 63110

  • Local Institution - 0128

    St. Petersburg, Florida, 33705

  • Local Institution - 0012

    Wichita, Kansas, 67214

  • Local Institution - 0016

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan22 sites

  • Local Institution - 0141

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 0071

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0146

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0198

    Gifu, Gifu, 5008513

  • Local Institution - 0193

    Hidaka, Saitama, 350-1298

  • Local Institution

    Hirakata-shi, Osaka, 5731191

  • Local Institution - 0138

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution - 0139

    Kashiwa-shi, Chiba, 2778577

  • Local Institution - 0076

    Kobe, Hyōgo, 6500047

  • Local Institution - 0140

    Koto-ku, Tokyo, 1358550

  • Local Institution - 0077

    Kurashiki-shi, Okayama-ken, 7108602

  • Local Institution - 0200

    Kurume-shi, Fukuoka, 8300011

  • Local Institution - 0142

    Matsuyama, Ehime, 7910280

  • Local Institution - 0145

    Osaka, Osaka, 5340021

  • Local Institution - 0075

    Osaka-sayama-shi, Osaka, 5898511

  • Local Institution - 0143

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0070

    Sendai, Miyagi, 9800873

  • Local Institution - 0069

    Sendai, Miyagi, 9808574

  • Local Institution - 0144

    Shinjuku-ku, Tokyo, 1600023

  • Local Institution - 0083

    Takatsuki-shi, Osaka, 5698686

  • Local Institution - 0216

    Wakayama, 641-8510

  • Local Institution - 0072

    Yokohama, Kanagawa, 2408555

Other trials in Japan

China20 sites

  • Local Institution

    Beijing, Beijing Municipality, 100001

  • Local Institution

    Beijing, Beijing Municipality, 100142

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution - 0247

    Changsha, 0

  • Local Institution - 0240

    Guangzhou, 510515

  • Local Institution - 0239

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0227

    Hangzhou, Zhejiang, 310016

  • Local Institution - 0221

    Harbin, Heilongjiang, 155040

  • Local Institution - 0238

    Hefei, Anhui, 230001

  • Local Institution - 0243

    Hefei, Anhui, 230022

  • Local Institution - 0232

    Kunming, Yunnan, 650118

  • Local Institution - 0230

    Nanchang, Jiangxi, 330006

  • Local Institution - 0248

    Nantong, Jiangsu, 226361

  • Local Institution - 0220

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 0228

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 0233

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0245

    Shanghai, Shanghai Municipality, 200433

  • Local Institution - 0237

    Shenyang, Liaoning, 110046

  • Local Institution - 0246

    Wenzhou, Zhejiang, 325000

  • Local Institution - 0244

    Wuhang, Hubei, 430030

Other trials in China

France9 sites

  • Local Institution - 0208

    Avignon Cedes 9, 84918

  • Local Institution - 0099

    Lyon, 69373

  • Local Institution - 0098

    Marseille, 13915

  • Local Institution - 0097

    Paris, 75970

  • Local Institution - 0095

    Pierre-Bénite, 69495

  • Local Institution - 0100

    Rennes, 35033

  • Local Institution - 0150

    Saint-Herblain, 44805

  • Local Institution - 0149

    Strasbourg, Alsace, 67091

  • Local Institution - 0096

    Toulouse, 31059

Other trials in France

Brazil8 sites

  • Local Institution - 0081

    Barretos, São Paulo, 14784-400

  • Local Institution - 0068

    Belo Horizonte, Minas Gerais, 30110-022

  • Local Institution - 0067

    Fortaleza, Ceará, 60430-230

  • Local Institution - 0063

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0017

    Itajaí, Santa Catarina, 88301-220

  • Local Institution - 0064

    Porto Alegre, Rio Grande do Sul, 90610000

  • Local Institution

    Rio de Janeiro, 22793-080

  • Local Institution

    Salvador, 40170-110

Other trials in Brazil

Germany8 sites

  • Local Institution - 0171

    Augsburg, 86156

  • Local Institution - 0170

    Bad Berka, 99437

  • Local Institution - 0168

    Berlin, 14165

  • Local Institution - 0164

    Bochum, 44791

  • Local Institution - 0166

    Gauting, 82131

  • Local Institution - 0165

    Großhansdorf, 22927

  • Local Institution - 0169

    Immenhausen, 34376

  • Local Institution - 0167

    Tübingen, 72076

Other trials in Germany

United Kingdom7 sites

  • Local Institution - 0118

    London, Greater London, NW1 2PG

  • Local Institution - 0201

    London, Greater London, SW3 6JJ

  • Local Institution - 0121

    Metropolitan Borough of Wirral, Lancashire, CH63 4JY

  • Local Institution - 0152

    Oxford, Oxfordshire, OX3 7LJ

  • Local Institution - 0192

    Sheffield, S10 2SJ

  • Local Institution - 0151

    Sutton, Surrey, SM2 5PT

  • Local Institution - 0153

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Australia6 sites

  • Local Institution - 0137

    Adelaide, South Australia, 5000

  • Local Institution

    Birtinya, Queensland, 4575

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Local Institution - 0035

    East Melbourne, Victoria, 3165

  • Local Institution

    Kogarah, New South Wales

  • Local Institution

    Wollongong, New South Wales, 2500

Other trials in Australia

Romania6 sites

  • Local Institution - 0199

    Bucharest, 010991

  • Local Institution - 0186

    Bucharest, 020122

  • Local Institution - 0182

    Craiova, 200347

  • Local Institution - 0178

    Lasi, 700106

  • Local Institution - 0212

    Romania, 400015

  • Local Institution - 0181

    Timisoara, Timis, 300239

Other trials in Romania

Russia6 sites

  • Local Institution - 0148

    Moscow, 105229

  • Local Institution - 0217

    Moscow, 115478

  • Local Institution - 0209

    Moscow, 121309

  • Local Institution - 0116

    Saint Petersburg, 194291

  • Local Institution - 0157

    Saint Petersburg, 197758

  • Local Institution - 0115

    Saint Petersburg, 198255

Other trials in Russia

Argentina5 sites

  • Local Institution - 0110

    Berazategui, Buenos Aires, 1880

  • Local Institution - 0088

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0109

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181

  • Local Institution - 0188

    Córdoba, 5004

  • Local Institution - 0029

    San Miguel de Tucumán, 4000

Other trials in Argentina

Canada5 sites

  • Local Institution - 0094

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0102

    Greater Sudbury, Ontario, P3E 5J1

  • Local Institution - 0136

    Moncton, New Brunswick, E1C 6Z8

  • Local Institution - 0123

    Oshawa, Ontario, L1G 2B9

  • Local Institution - 0111

    Windsor, Ontario, N8W 1L9

Other trials in Canada

Ireland5 sites

  • Local Institution - 0175

    Dublin, 24

  • Local Institution

    Dublin, 4

  • Local Institution - 0162

    Galway, ST4 6QG

  • Local Institution - 0214

    Limerick, 0

  • Local Institution - 0161

    Wilton, CORK, 0

Other trials in Ireland

Israel5 sites

  • Local Institution

    Haifa, 31096

  • Local Institution - 0093

    Jerusalem, 91031

  • Local Institution

    Petah Tikva, 49100

  • Local Institution - 0090

    Tel Aviv, 64239

  • Local Institution - 0089

    Tsrifin, 70300

Other trials in Israel

Italy5 sites

  • Local Institution - 0026

    Avellino, 83100

  • Local Institution - 0025

    Bologna, 40138

  • Local Institution - 0112

    Messina, 98158

  • Local Institution - 0027

    Milan, Lombardy, 20141

  • Local Institution - 0082

    Perugia, 06132

Other trials in Italy

South Korea5 sites

  • Local Institution - 0021

    Gangnam-gu, 06351

  • Local Institution - 0047

    Seongnam-si, Gyeonggi-do, 13620

  • Local Institution - 0022

    Seoul, 03722

  • Local Institution - 0154

    Seoul, 05505

  • Local Institution - 0024

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

Spain5 sites

  • Local Institution - 0132

    Barcelona, 08035

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Madrid, 28040

  • Local Institution

    Málaga, 29011

  • Local Institution

    Seville, 41013

Other trials in Spain

Finland4 sites

  • Local Institution - 0044

    Oulu, 90029

  • Local Institution - 0043

    Tampere, 33521

  • Local Institution - 0045

    Turku, FIN-20521

  • Local Institution - 0046

    Vaasa, 65130

Other trials in Finland

Mexico4 sites

  • Local Institution - 0020

    León, Guanajuato, 37000

  • Local Institution - 0019

    Mexico City, Mexico City, 14050

  • Local Institution - 0028

    Monterrey, Nuevo León, 64000

  • Local Institution - 0135

    Querétaro, 76090

Other trials in Mexico

Poland4 sites

  • Local Institution - 0041

    Gdansk, 80-19

  • Local Institution - 0054

    Gdynia, 81-519

  • Local Institution - 0053

    Olsztyn, 10-357

  • Local Institution - 0187

    Warsaw, 02-781

Other trials in Poland

South Africa4 sites

  • Local Institution - 0084

    Cape Town, Western Cape, 7570

  • Local Institution - 0085

    Cape Town, Western Cape, 7700

  • Local Institution - 0086

    George, Western Cape, 6530

  • Local Institution - 0087

    Sandton, Gauteng, 2199

Other trials in South Africa

Austria3 sites

  • Local Institution - 0174

    Innsbruck, 6020

  • Local Institution - 0173

    Salzburg, 5020

  • Local Institution - 0172

    Vienna, 1130

Other trials in Austria

Belgium3 sites

  • Local Institution - 0057

    Brussels, 1090

  • Local Institution - 0059

    Charleroi, 6000

  • Local Institution - 0060

    Roeselare, 8800

Other trials in Belgium

Colombia3 sites

  • Local Institution - 0078

    Bogotá, 0

  • Local Institution

    Medellín, MEDELLIN

  • Local Institution

    Montería, Departamento de Córdoba

Other trials in Colombia

Netherlands3 sites

  • Local Institution - 0158

    's-Hertogenbosch, 5223 GZ

  • Local Institution

    Eindhoven, 5623 EJ

  • Local Institution - 0159

    Rotterdam, 3000 CA

Other trials in Netherlands

Peru3 sites

  • Local Institution

    Lima, 27

  • Local Institution

    Lima, 34

  • Local Institution

    Miraflores, Lima region, 18

Other trials in Peru

Switzerland3 sites

  • Local Institution - 0179

    Aarau, 5001

  • Local Institution - 0180

    Geneva, 1205

  • Local Institution - 0191

    Sankt Gallen, 9007

Other trials in Switzerland

Greece2 sites

  • Local Institution - 0080

    N.Kifissia, 14564

  • Interbalkan European Medical Center

    Thessaloniki, 57001

Other trials in Greece

Sweden2 sites

  • Local Institution - 0124

    Lund, 221 85

  • Local Institution - 0185

    Uppsala, 751 85

Other trials in Sweden

Taiwan2 sites

  • Local Institution - 0049

    Tainan, TNN, 704

  • Local Institution - 0048

    Taoyuan, 333

Other trials in Taiwan

Hong Kong1 site

  • Local Institution - 0052

    Hong Kong, 0

Other trials in Hong Kong

Singapore1 site

  • Local Institution - 0050

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Conditions
Lung Cancer
Being tested
Nivolumab, Ipilimumab, Placebo
Medical subject headings
Lung Neoplasms

What participants receive

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

Study groups in NCT02538666
Study groupRoleWhat they receive
Nivolumab monotherapyExperimentalNivolumab intravenous fusion
Receives: Biological: Nivolumab
Nivolumab and ipilimumab combination therapyExperimentalNivolumab and ipilimumab intravenous fusion
Receives: Biological: Nivolumab; Biological: Ipilimumab
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

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

  1. Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population

    OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug

    Measured: From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)

Secondary outcomes (5)

  1. Overall Survival (OS) of Nivolumab Versus Placebo

    Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.

    Measured: From randomization to the date of death or last known alive date (up to approximately 73 months)

  2. Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab

    Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.

    Measured: From randomization to the date of death or last known alive date (up to approximately 73 months)

  3. Progression Free Survival (PFS) Per BICR

    PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.

    Measured: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)

  4. Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population

    Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.

    OS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb

    Measured: From randomization to the date of death or last known alive date (up to approximately 73 months)

  5. Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population

    Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.

    PFS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb.

    Measured: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)

Timeline

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

  1. First posted2 Sep 2015 (estimated)
  2. Study start13 Oct 2015
  3. Primary completion1 Oct 2018
  4. Study completion11 Nov 2021

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
907 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02538666
Sponsor's protocol ID
CA209-451
Other IDs
2015-002441-61, 2015
Acronym
CheckMate 451
Status last verified
Dec 2022
First submitted
26 Aug 2015
Last updated
5 Jan 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.

    PubMed 35383114

  • Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodriguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.

    PubMed 33683919

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Ipilimumab in people with Lung Cancer, run by Bristol-Myers Squibb at 197 sites in 32 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 3 inclusion and 5 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Japan, China, France, Brazil and 27 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 22 Oct 2019). 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) of Nivolumab + Ipilimumab Versus Placebo In The Global Population (time frame: From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 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 NCT02538666, 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 5 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in