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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

812

Phase

  • 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

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
Intervention / Treatment
Experimental: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Drug: Nivolumab

What is the study measuring?

Primary Outcome Measures

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

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

Bristol-Myers Squibb

Collaborators

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)

April 29, 2015

Primary Completion (Actual)

March 7, 2018

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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