An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)

October 17, 2022 updated by: Bristol-Myers Squibb
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
812

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0003
      • Wien, Austria, 1140
        • Local Institution - 0005
    • Oberösterreich
      • Wels, Oberösterreich, Austria, 4600
        • Local Institution - 0002
  • Denmark
      • Aalborg, Denmark, 9000
        • Local Institution - 0021
      • Herlev, Denmark, 2730
        • Local Institution - 0020
    • South Denmark
      • Odense, South Denmark, Denmark, 5000
        • Local Institution - 0173
  • Finland
      • Pori, Finland, FI-28500
        • Local Institution - 0023
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90230
        • Local Institution - 0022
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 0051
      • Heraklion, Greece, 71110
        • Local Institution - 0052
      • Nea Kifisia Athens, Greece, 14564
        • Local Institution - 0177
      • Patras, Greece, 26504
        • Local Institution - 0148
      • Thessaloniki, Greece, 57010
        • Local Institution - 0147
  • Hungary
      • Budapest, Hungary, 1121
        • Local Institution - 0053
      • Budapest, Hungary, 1125
        • Local Institution - 0347
      • Debrecen, Hungary, 4032
        • Local Institution - 0178
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Local Institution - 0054
  • Ireland
      • Dublin 8, Ireland
        • Local Institution - 0056
      • Galway, Ireland, ST4 6QG
        • Local Institution - 0058
      • Tullamore, Offaly, Ireland
        • Local Institution - 0349
  • Poland
      • Gdansk, Poland, 80-214
        • Local Institution - 0086
      • Lodz, Poland, 90-302
        • Local Institution - 0088
      • Warszawa, Poland, 04-141
        • Local Institution - 0089
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-100
        • Local Institution - 0158
      • Zabrze, Slaskie, Poland, 41-803
        • Local Institution - 0184
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-693
        • Local Institution - 0087
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Local Institution - 0094
      • Lisboa, Portugal, 1099-023
        • Local Institution - 0093
      • Lisboa, Portugal, 1769-001
        • Local Institution - 0090
      • Porto, Portugal, 4099-001
        • Local Institution - 0092
      • Porto, Portugal, 4200-072
        • Local Institution - 0091
      • Porto, Portugal, 4200-319
        • Local Institution - 0159
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0095
      • Bucharest, Romania, 030171
        • Local Institution - 0096
      • Cluj Napoca, Romania, 400015
        • Local Institution - 0097
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Local Institution - 0192
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400058
        • Local Institution - 0098
    • Timis
      • Timisoara, Timis, Romania, 300167
        • Local Institution - 0187
  • Russian Federation
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 197758
        • Local Institution - 0100
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Local Institution - 0160
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • Local Institution - 0099
  • Spain
      • A Coruna, Spain, 15006
        • Local Institution - 0104
      • Alicante, Spain, 03010
        • Local Institution - 0119
      • Barcelona, Spain, 08036
        • Local Institution - 0162
      • Barcelona, Spain, 08916
        • Local Institution - 0112
      • Barcelona, Spain, 8028
        • Local Institution - 0111
      • Barcelona, Spain, 8035
        • Local Institution - 0110
      • Burgos, Spain, 09006
        • Local Institution - 0108
      • Granada, Spain, 18014
        • Local Institution - 0103
      • Madrid, Spain, 28034
        • Local Institution - 0114
      • Madrid, Spain, 28040
        • Local Institution - 0117
      • Madrid, Spain, 28041
        • Local Institution - 0116
      • Madrid, Spain, 28046
        • Local Institution - 0105
      • Malaga, Spain, 29010
        • Local Institution - 0106
      • Palma de Mallorca, Spain, 07198
        • Local Institution - 0113
      • Seville, Spain, 41013
        • Local Institution - 0118
      • Valencia, Spain, 46010
        • Local Institution - 0161
      • Valencia, Spain, 46026
        • Local Institution - 0102
      • Zaragoza, Spain, 50009
        • Local Institution - 0163
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Local Institution - 0337
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0109
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Local Institution - 0107
  • Sweden
      • Linköping, Sweden, 581 85
        • Local Institution - 0348
      • Lund, Sweden, 22185
        • Local Institution - 0342
      • Stockholm, Sweden, 171 76
        • Local Institution - 0120
    • Orebro Lan
      • Örebro, Orebro Lan, Sweden, SE-70185
        • Local Institution - 0339
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sweden, 17176
        • Local Institution - 0346
    • Vastra Gotalands Lan
      • Goteborg, Vastra Gotalands Lan, Sweden, 41345
        • Local Institution - 0193
  • United Kingdom
      • Bebington, United Kingdom, CH63 4JY
        • Local Institution - 0171
      • Bodelwyddan, Rhyl, United Kingdom, LL18 5UJ
        • Local Institution - 0340
      • Bradford, United Kingdom, BD9 6RJ
        • Local Institution - 0344
      • Bristol, United Kingdom, BS2 8ED
        • Local Institution - 0190
      • Cardiff, United Kingdom, CF14 2TL
        • Local Institution - 0133
      • Cottingham, United Kingdom, HU16 5JQ
        • Local Institution - 0126
      • London, United Kingdom, W1T 7HA
        • Local Institution - 0165
      • London, United Kingdom, W6 8RF
        • Local Institution - 0169
      • Northwood, United Kingdom, HA6 2RN
        • Local Institution - 0194
      • Plymouth, United Kingdom, PL6 8DH
        • Local Institution - 0166
      • Sheffield, United Kingdom, S10 5SJ
        • Local Institution - 0124
      • Sutton, United Kingdom, SM2 5PT
        • Local Institution - 0189
      • West Midlands, United Kingdom, CV2 2DX
        • Local Institution - 0338
    • Aberdeen CITY
      • Aberdeen, Aberdeen CITY, United Kingdom, AB25 2ZN
        • Local Institution - 0345
    • Greater London
      • London, Greater London, United Kingdom, N18 1QX
        • Local Institution - 0127
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0191
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution - 0131
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Local Institution - 0128
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution - 0195
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Local Institution - 0132
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Local Institution - 0167
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • ECOG Status: PS 0-1 & PS 2
  • Subjects with histologically or cytologically-documented SqNSCLC
  • Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
  • Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
  • Subjects with treated or asymptomatic CNS metastases
  • Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
  • Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
  • Males and Females, ages 18 or older

Exclusion Criteria:

  • Subjects with untreated, symptomatic CNS metastases
  • Subjects with carcinomatous meningitis
  • Subjects with active, known or suspected autoimmune disease.
  • Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Drug: Nivolumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Time Frame: From first dose to time of analysis of primary endpoint (approximately up to 34 months)
The total number of participants with high grade treatment related select adverse events.
From first dose to time of analysis of primary endpoint (approximately up to 34 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With High Grade Select Adverse Events
Time Frame: From first dose up to 100 days post last dose (up to 76 months)
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose up to 100 days post last dose (up to 76 months)
Median Time to Onset of Any Grade Select Adverse Events
Time Frame: From first dose up to 100 days post last dose (up to approximately 65 months)
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose up to 100 days post last dose (up to approximately 65 months)
Median Time to Resolution of Any Grade Select Adverse Events
Time Frame: From first dose to up to 100 days post last dose (up to approximately 45 months)
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose to up to 100 days post last dose (up to approximately 45 months)
Overall Survival
Time Frame: From the first dosing up to the date of death (up to approximately 76 months)
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
From the first dosing up to the date of death (up to approximately 76 months)
Objective Response Rate (ORR)
Time Frame: From first dose up to last dose (up to approximately 76 months)
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
From first dose up to last dose (up to approximately 76 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PPD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-171
  • 2014-001285-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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