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Non Small Cell Lung Cancer (NSCLC)Phase 3CheckMate153NCT02066636

A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen

A Phase 3 study testing Nivolumab in people with Non Small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 134 sites in 2 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 estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer (NSCLC)
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,428 participants
Where
134 sitesin 2 countries
Study dates
9 Apr 2014to 6 Oct 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

  • 1. Target Population
  • Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
  • Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
  • Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
  • Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
  • Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Show all 13Show fewer
  • Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
  • Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
  • Experimental therapies when given as separate regimen are considered as separate line of therapy
  • Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
  • Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
  • PS 0 to 1
  • PS 2

Who cannot join

  • Target Disease Exceptions
  • Subjects with active central nervous system (CNS) metastases are excluded
  • Subjects with carcinomatous meningitis
  • Medical History and Concurrent Diseases
  • Subjects with a history of interstitial lung disease
  • Subjects with active, known or suspected autoimmune disease
Show all 10Show fewer
  • Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents
  • Prohibited Treatments and/or Restricted Therapies
  • Ongoing or planned administration of anti-cancer therapies other than those specified in this study
  • Use of corticosteroids or other immunosuppressive medications

Trial locations and contacts

134 sites in 2 countries.

134 sites in 2 countries

United States127 sites

  • Texas Oncology-Abilene

    Abilene, Texas, 79606

  • St. Peters Hospital

    Albany, New York, 12208

  • Presbyterian Medical Group

    Albuquerque, New Mexico, 87110

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Michigan Cancer Research Consortinum

    Ann Arbor, Michigan, 48016

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Texas Oncology

    Arlington, Texas, 76012

  • Randolph Cancer Center

    Asheboro, North Carolina, 27203

  • University Cancer Blood Ctr

    Athens, Georgia, 30607

  • Piedmont Hospital

    Atlanta, Georgia, 30318

  • Comprehensive Blood And Cancer Center

    Bakersfield, California, 93309

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Texas Oncology-Beaumont

    Beaumont, Texas, 77702

  • Texas Oncology

    Bedford, Texas, 76022

  • Walter Reed National Mltry Medical Center

    Bethesda, Maryland, 20889

  • St. Luke's University Hospital Bethlehem

    Bethlehem, Pennsylvania, 18015

  • Mid Dakota Clinic, Pc

    Bismarck, North Dakota, 58501

  • Local Institution

    Brewer, Maine, 04412

  • Maimonides Medical Center

    Brooklyn, New York, 11220

  • Charleston Hematology Oncology Associates, Pa

    Charleston, South Carolina, 29414

  • University Of Virginia Health System.

    Charlottesville, Virginia, 22908

  • Tennessee Oncology, PLLC - SCRI - PPDS

    Chattanooga, Tennessee, 37404

  • University Of Illinois Cancer Center

    Chicago, Illinois, 60612

  • Oncology Hematology Care, Incorporated

    Cincinnati, Ohio, 45242

  • Local Institution

    Cleveland, Ohio, 44195

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • Diablo Valley Oncology

    Concord, California, 94520-2054

  • Texas Oncology

    Dallas, Texas, 75230

  • Texas Oncology

    Dallas, Texas, 75231

  • Local Institution - 0067

    Dallas, Texas, 75246

  • Texas Oncology

    Denton, Texas, 76201

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Bay Hematology Oncology

    Easton, Maryland, 21601

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Holy Cross Hospital Inc.

    Fort Lauderdale, Florida, 33308-4603

  • Florida Cancer Specialists S.

    Fort Myers, Florida, 33901

  • Local Institution - 0081

    Fort Wayne, Indiana, 46804

  • The Center For Cancer And Blood Disorders

    Fort Worth, Texas, 76104

  • Queens Medical Associates

    Fresh Meadows, New York, 11366

  • Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center

    Fullerton, California, 92835

  • Cancer Care Of Wnc

    Germantown, Tennessee, 38138

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • The West Clinic, P.C.

    Germantown, Tennessee, 38138

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Cancer Center Treatment Center of America

    Goodyear, Arizona, 85338

  • St. Mary's Hospital Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Cancer & Hematology Centers Of Western Michigan

    Grand Rapids, Michigan, 49503

  • Moses Cone Regional Cancer Center

    Greensboro, North Carolina, 27403

  • Greenville Health System

    Greenville, South Carolina, 29605

  • East Carolina University Leo W. Jenkins Cancer Center

    Greeville, North Carolina, 27834

  • Forrest General Cancer Center

    Hattiesburg, Mississippi, 39401

  • Northwest Cancer Center

    Houston, Texas, 77090

  • Indiana University Health Melvin And Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Jackson Oncology Associates, Pllc

    Jackson, Mississippi, 39202

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Broome Oncology

    Johnson City, New York, 13790

  • Local Institution - 0031

    Lakeland, Florida, 33805

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Comprehensive Cancer Center Of Nevada

    Las Vegas, Nevada, 89119

  • Southeast Nebraska Hematology & Oncology Consultants, P.C.

    Lincoln, Nebraska, 68510

  • Ucla Hema/Onc-Santa Monica

    Los Angeles, California, 90095

  • Norton Cancer Center

    Louisville, Kentucky, 40202

  • University Medical Center, Inc

    Louisville, Kentucky, 40202

  • Central Georgia Cancer Care, Pc

    Macon, Georgia, 31201

  • Texas Oncology

    McAllen, Texas, 78503

  • Texas Oncology

    Mesquite, Texas, 75150

  • Local Institution - 0038

    Miami, Florida, 33176

  • Texas Oncology - Odessa

    Midland, Texas, 79701

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Southern Cancer Center Pc

    Mobile, Alabama, 36608

  • Pacific Cancer Care

    Monterey, California, 93940

  • Mount Kisco Medical Group

    Mount Kisco, New York, 10549

  • Tennessee Oncology, Pllc

    Nashville, Tennessee, 37203

  • Henry-Joyce Cancer Center

    Nashville, Tennessee, 37232-0021

  • Columbia University Medical Center (Cumc)

    New York, New York, 10032

  • Cancer Treatment Centers Of America

    Newnan, Georgia, 30265

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • University Of Kansas Cancer Center

    North Kansas City, Missouri, 64116

  • Eastern Ct Hem Onc Assoc

    Norwich, Connecticut, 06360

  • Hematology-Oncology Associates Of Rockland

    Nyack, New York, 10960

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Cancer Institute Of Florida

    Orlando, Florida, 32804

  • West KY Hematology Oncology Group PSC

    Paducah, Kentucky, 42003

  • Oncology Specialists

    Park Ridge, Illinois, 60068

  • Memorial Cancer Institute

    Pemroke Pines, Florida, 33028

  • Local Institution - 0071

    Pensacola, Florida, 32504

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Texas Oncology-Plano East

    Plano, Texas, 75075

  • Hematology/Oncology Associates Of The Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • VA Sierra Nevada Health Care System

    Reno, Nevada, 89502

  • Sutter Cancer Center

    Sacramento, California, 95816

  • W.G. Bill Hefner VA Medical Center

    Salisbury, North Carolina, 28144

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Cancer Care Centers Of South Texas

    San Antonio, Texas, 78212

  • Local Institution

    San Francisco, California, 94117

  • Central Coast Med Oncology

    San Luis Obispo, California, 93401

  • Sansum Santa Barbara Medical Foundation Clinic

    Santa Barbara, California, 93105

  • Central Coast Med Oncology

    Santa Maria, California, 93454

  • Summit Cancer Care

    Savannah, Georgia, 31405

  • Arizona Oncology Associates

    Sedona, Arizona, 86336

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Christus Schumpert Health

    Shreveport, Louisiana, 71105

  • Local Institution - 0015

    Skokie, Illinois, 60077

  • Providence Cancer Center

    Southfield, Michigan, 48075

  • Southern Illinois University School Of Medicine

    Springfield, Illinois, 62794-9678

  • Mercy Medical Research Institute

    Springfield, Missouri, 65807

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Atlantic Health System

    Summit, New Jersey, 07091

  • Local Institution - 0108

    Tampa, Florida, 33612

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792

  • Space Coast Cancer Center

    Titusville, Florida, 32796

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope

    Tucson, Arizona, 85704

  • North Mississippi Hematology And Oncology Associates, Ltd

    Tupelo, Mississippi, 38801

  • Pearlman Cancer Center

    Valdosta, Georgia, 31602

  • Texas Oncology Cancer Care And Research Center

    Waco, Texas, 76712

  • Cancer Center Of Kansas

    Wichita, Kansas, 67214

  • Shenandoah Oncology

    Winchester, Virginia, 22601

Other trials in United States

Canada7 sites

  • Local Institution

    Calgary, Alberta, T2N 4N2

  • Local Institution

    Halifax, Nova Scotia, B3H 2Y9

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Local Institution

    Lévis, Quebec, G6V 3Z1

  • Local Institution

    Montreal, Quebec, H3T 1E2

  • Local Institution

    Ottawa, Ontario, K1H 8L6

  • Local Institution

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

Being tested
Nivolumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

Study groups in NCT02066636
Study groupRoleWhat they receive
Cohort A: NivolumabExperimentalNivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent
Receives: Drug: Nivolumab
Cohort B: NivolumabExperimentalNivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed
Receives: Drug: Nivolumab

What is being measured

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

  1. The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)

    A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

Secondary outcomes (6)

  1. Median Time to Onset of Select Adverse Events (Grade 3-5)

    The time from first dose to the first occurrence of any select adverse event of interest. 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 an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

  2. Median Time to Resolution of Select Adverse Events (Grade 3-5)

    The time from the onset of any select adverse event of interest to its resolution or stabilization. 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 an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

  3. The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events

    The number of participants receiving medication meant to trigger an immune response for any select Adverse events of interest. 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 an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

  4. The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events

    The number of participants receiving > 40mg prednisone equivalents for any select adverse event of interest. 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 an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

  5. The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events

    The duration of time participants received medication meant to trigger an immune response for any select Adverse events of interest. 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 an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

  6. The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events

    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 an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

    Measured: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

Timeline

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

  1. First posted19 Feb 2014 (estimated)
  2. Study start9 Apr 2014
  3. Primary completion6 Oct 2021
  4. Study completion6 Oct 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
None (open label)
Enrolment
1,428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02066636
Sponsor's protocol ID
CA209-153
Acronym
CheckMate153
Status last verified
Sep 2022
First submitted
14 Feb 2014
Last updated
27 Oct 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Spigel DR, McCleod M, Jotte RM, Einhorn L, Horn L, Waterhouse DM, Creelan B, Babu S, Leighl NB, Chandler JC, Couture F, Keogh G, Goss G, Daniel DB, Garon EB, Schwartzberg LS, Sen R, Korytowsky B, Li A, Aanur N, Hussein MA. Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153). J Thorac Oncol. 2019 Sep;14(9):1628-1639. doi: 10.1016/j.jtho.2019.05.010. Epub 2019 May 20.

    PubMed 31121324

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab in people with Non Small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 134 sites in 2 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 13 inclusion and 10 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Canada. 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 27 Oct 2022). 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?

The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5) (time frame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 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 NCT02066636, which also lists 1 linked publication.

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 27 Oct 2022.

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