AzTrials
AzTrials

Lung CancerPhase 3CheckMate 384NCT02713867

A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

A Phase 3 study testing Nivolumab in people with Lung Cancer, run by Bristol-Myers Squibb at 129 sites in 8 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 primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq). 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363 participants
Where
129 sitesin 8 countries
Study dates
24 May 2016to 18 Jan 2022
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

  • Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
  • Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
  • Measurable disease before start of pre-study nivolumab treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Who cannot join

  • Carcinomatous meningitis
  • Untreated, symptomatic Central nervous system (CNS) metastases
  • Symptomatic interstitial lung disease
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

129 sites in 8 countries.

129 sites in 8 countries

United States77 sites

  • Local Institution - 0023

    Abilene, Texas, 79606-5208

  • Local Institution - 0035

    Albany, New York, 12206

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Local Institution - 0008

    Athens, Georgia, 30607

  • CBCC Global Research, Inc.

    Bakersfield, California, 93309

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Southern California Permanente Medical Group

    Bellflower, California, 90706

  • Local Institution - 0042

    Bethesda, Maryland, 20817

  • Local Institution - 0004

    Birmingham, Alabama, 35205

  • Local Institution - 0109

    Brewer, Maine, 04412

  • Hematology And Oncology Associates

    Canton, Ohio, 44708

  • Local Institution - 0020

    Charleston, South Carolina, 29414

  • Local Institution - 0037

    Cincinnati, Ohio, 45242

  • Local Institution - 0132

    Cincinnati, Ohio, 45242

  • MetroHealth Cancer Care Center

    Cleveland, Ohio, 44109

  • Local Institution - 0142

    Columbus, Georgia, 31904

  • Local Institution - 0011

    Dallas, Texas, 75230

  • Local Institution - 0022

    Dallas, Texas, 75231

  • Texas Oncology, P.A.

    Denton, Texas, 76210

  • Local Institution - 0017

    Denver, Colorado, 80218-1210

  • Texas Oncology, P.A.

    El Paso, Texas, 79902

  • Innova Schar Cancer Institute

    Falls Church, Virginia, 22042

  • Local Institution - 0025

    Flower Mound, Texas, 75028

  • Local Institution - 0122

    Fort Collins, Colorado, 80528

  • Local Institution - 0038

    Fort Myers, Florida, 33901

  • Local Institution - 0099

    Fort Wayne, Indiana, 46485

  • Local Institution - 0050

    Fort Wayne, Indiana, 46804

  • St Jude Hospital Yorba Linda

    Fullerton, California, 92835

  • Jones Clinic PC

    Germantown, Tennessee, 38138

  • Ingalls Health System

    Harvey, Illinois, 60426

  • Local Institution - 0089

    Hollywood, Florida, 33021

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Innova Schar Cancer Institute

    Indianapolis, Indiana, 46237

  • Local Institution - 0013

    Johnson City, New York, 13790

  • Local Institution - 0141

    Lebanon, New Hampshire, 03756

  • Texas Oncology, P.A.

    Longview, Texas, 75601

  • Local Institution - 0046

    Los Angeles, California, 90095

  • Local Institution - 0121

    Marietta, Georgia, 30060

  • Local Institution - 0129

    Massillon, Ohio, 44646

  • Hematology Oncology Consultants, Pc

    Medford, Oregon, 97504

  • Local Institution - 0119

    Midland, Texas, 79701

  • Local Institution - 0120

    Minneapolis, Minnesota, 55404

  • Local Institution - 0036

    Nashville, Tennessee, 37203

  • Local Institution - 0137

    New Orleans, Louisiana, 70121

  • Local Institution - 0098

    Niles, Illinois, 60714

  • Local Institution - 0026

    Ocala, Florida, 34471

  • Local Institution - 0014

    Omaha, Nebraska, 68130

  • Local Institution - 0126

    Orange, California, 92868

  • Local Institution - 0112

    Paducah, Kentucky, 42003

  • Local Institution - 0001

    Pensacola, Florida, 32504

  • Local Institution - 0100

    Peoria, Illinois, 61615

  • Local Institution - 0030

    Phoenix, Arizona, 85016

  • Local Institution - 0041

    Phoenix, Arizona, 85016

  • Local Institution - 0127

    Pinehurst, North Carolina, 28374

  • Local Institution - 0005

    Pittsburgh, Pennsylvania, 15224

  • Texas Oncology, P.A.

    Plano, Texas, 75093

  • Torrance Health Association

    Redondo Beach, California, 90227

  • Texas Oncology, P.A.

    San Antonio, Texas, 78212

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Local Institution - 0010

    Santa Barbara, California, 93015

  • Local Institution - 0044

    Santa Maria, California, 93454

  • Texas Oncology, P.A.

    Sherman, Texas, 75090

  • Local Institution - 0124

    Sioux Falls, South Dakota, 57105

  • Local Institution - 0136

    Southfield, Michigan, 48075

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Local Institution - 0125

    Springfield, Massachusetts, 01107

  • Mercy Medical Research Institute

    Springfield, Missouri, 65806

  • Local Institution - 0039

    St. Petersburg, Florida, 33705

  • Texas Oncology, P.A.

    Sugar Land, Texas, 77479

  • Local Institution - 0116

    Tupelo, Mississippi, 38801

  • Local Institution - 0143

    Urbana, Illinois, 61801-2594

  • Local Institution - 0130

    Vallejo, California, 94589

  • Local Institution - 0031

    Vancouver, Washington, 98684

  • Local Institution - 0123

    Wichita, Kansas, 67214

  • Local Institution - 0034

    Wichita Falls, Texas, 76310

  • Shenandoah Oncology

    Winchester, Virginia, 22601

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

France14 sites

  • Local Institution - 0081

    Angers, 49000

  • Local Institution - 0105

    Angers, 49000

  • Local Institution - 0080

    Bayonne, 64109

  • Local Institution - 0076

    Clermont-Ferrand, 63003

  • Local Institution - 0077

    Le Mans, 72000

  • Local Institution - 0072

    Mulhouse, 68100

  • Local Institution - 0078

    Nîmes, 30029

  • Local Institution - 0095

    Paris, 75005

  • Local Institution - 0083

    Paris, 75014

  • Local Institution

    Pontoise, 95300

  • Local Institution - 0075

    Suresnes, 92 151

  • Local Institution - 0079

    Tours, 37044

  • Local Institution - 0097

    Vandœuvre-lès-Nancy, 54519

  • Local Institution - 0096

    Villefranche-sur-Saône, 69655

Other trials in France

Germany14 sites

  • Local Institution

    Bad Berka, 99437

  • Local Institution - 0073

    Berlin, 13353

  • Local Institution - 0063

    Dresden, 01307

  • Local Institution

    Freiburg im Breisgau, 79106

  • Local Institution - 0102

    Gauting, 82131

  • Local Institution - 0062

    Greifenstein, 35753

  • Local Institution - 0061

    Hamburg, 20251

  • Local Institution - 0113

    Hanover, 30625

  • Local Institution - 0064

    Kassel, 34125

  • Local Institution - 0106

    Kiel, 24105

  • Local Institution - 0065

    Leipzig, 04357

  • Local Institution

    Lostau, 39291

  • Local Institution - 0066

    Moers, 47447

  • Local Institution - 0067

    Nuremberg, 90419

Other trials in Germany

Australia10 sites

  • Local Institution - 0054

    Bedford Park, South Australia, 5042

  • Local Institution - 0056

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0053

    Heidelberg, Victoria, 3084

  • Local Institution - 0057

    Hobart, Tasmania, 7000

  • Local Institution - 0055

    Kurralta Park, South Australia, 5037

  • Local Institution - 0058

    Murdoch, Western Australia, 6150

  • Local Institution - 0052

    St Leonards, New South Wales, 2065

  • Local Institution - 0118

    Waratah, New South Wales, 2298

  • Local Institution - 0117

    Westmead, New South Wales, 2145

  • Local Institution - 0093

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada5 sites

  • Local Institution - 0146

    Laval, Quebec, H7M 3L9

  • Local Institution - 0145

    Montreal, Quebec, H4J 1C5

  • Local Institution - 0059

    Newmarket, Ontario, L3Y 2P9

  • Local Institution

    Québec, Quebec, GIJ 1Z4

  • Local Institution - 0060

    Saint-Jérôme, Quebec, J7Z 5T3

Other trials in Canada

Italy4 sites

  • Local Institution - 0086

    Localita San Filippo Lucca, 55100

  • Local Institution - 0085

    Monza, 20900

  • Local Institution - 0088

    Naples, 80131

  • Local Institution - 0087

    Roma, 00128

Other trials in Italy

Spain4 sites

  • Local Institution - 0069

    Barcelona, 08208

  • Local Institution - 0104

    El Palmar, 30120

  • Local Institution - 0068

    Las Palmas de Gran Canaria, 35016

  • Local Institution - 0070

    Seville, 41013

Other trials in Spain

Austria1 site

  • Local Institution

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Conditions
Lung Cancer
Being tested
Nivolumab
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 NCT02713867
Study groupRoleWhat they receive
Nivolumab 240 mgActive comparatorNivolumab 240 mg Every 2 Weeks
Receives: Biological: Nivolumab
Nivolumab 480 mgExperimentalNivolumab 480 mg Every 4 Weeks
Receives: Biological: Nivolumab

What is being measured

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

  1. Progression Free Survival Rate (PFSR) at 6 Months

    The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.

    Measured: At 6 Months

  2. Progression Free Survival Rate (PFSR) at 12 Months

    The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.

    Measured: At 12 Months

Secondary outcomes (15)

  1. Progression Free Survival Rate (PFSR) at 24 Months

    The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.

    Measured: At 24 Months

  2. Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months

    The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.

    Measured: At 12 Months

  3. Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months

    The proportion of participants remaining progression free and surviving at 12 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: At 12 Months

  4. Overall Survival (OS) Rate at 12 Months

    The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.

    Measured: At 12 Months

  5. Overall Survival (OS) Rate up to 60 Months

    The proportion of participants alive up to 60 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.

    Measured: From randomization to the date of death, Up to 60 Months

  6. Overall Survival Rate by Histology at 12 Months

    The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.

    OS rate by histology did not have data collected after 12 months randomization.

    Measured: at 12 Months

  7. Overall Survival Rate by Response Criteria at 12 Months

    The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    OS rate by response did not have data collected after 12 months randomization.

    Measured: 12 Months

  8. Percentage of Participants With an Adverse Events (AEs)

    Percentage of participants with an Adverse Event due to any cause

    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 drug and that does not necessarily have a causal relationship with this treatment.

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  9. Percentage of Participants With an Serious Adverse Events (SAEs)

    Percentage of participants with an Serious Adverse Event due to any cause.

    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

    1. results in death
    2. is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
    3. requires inpatient hospitalization or causes prolongation of existing hospitalization
    4. results in persistent or significant disability/incapacity
    5. is a congenital anomaly/birth defect
    6. is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.)

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  10. Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)

    Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause.

    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 drug and that does not necessarily have a causal relationship with this treatment.

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  11. Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)

    Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  12. Percentage of Participants With an Select Adverse Events

    Percentage of Participants with an Select Adverse Event due to any cause

    Select adverse events include adverse events in the following systems: Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, Hypersensitivity/Infusion reaction and Endocrine.

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  13. Percentage of Participants With an Event of Special Interest (ESI)

    Other ESI included the following categories: demyelination, encephalitis, Guillain-Barré syndrome (GBS), myasthenic syndrome, pancreatitis, uveitis, myositis, myocarditis, rhabdomyolysis, and Graft Versus Host Disease (GVHD).

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  14. Percentage of Participants Who Experienced Death

    Percentage of Participants who experienced Death due to any cause

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

  15. Number of Participants With Laboratory Test Abnormalities

    Number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)

    Measured: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Timeline

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

  1. First posted21 Mar 2016 (estimated)
  2. Study start24 May 2016
  3. Primary completion15 Jul 2019
  4. Study completion18 Jan 2022

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
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713867
Sponsor's protocol ID
CA209-384
Acronym
CheckMate 384
Status last verified
Jan 2023
First submitted
11 Mar 2016
Last updated
14 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab in people with Lung Cancer, run by Bristol-Myers Squibb at 129 sites in 8 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: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, France, Germany, Australia, Canada and 3 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 22 Jun 2020). 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?

Progression Free Survival Rate (PFSR) at 6 Months (time frame: At 6 Months). The study lists 2 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 NCT02713867.

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 14 Feb 2023.

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