Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    BMS CA 209-171
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02409368
Recruitment Status : Active, not recruiting
First Posted : April 6, 2015
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : April 23, 2015
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : December 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

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



Primary Outcome Measures :
  1. Incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in subjects with advanced or metastatic SqNSCLC [ Time Frame: Approximately 5 years ]

Secondary Outcome Measures :
  1. Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events [ Time Frame: Approximately 5 years ]
  2. Overall survival (OS) in all treated subject [ Time Frame: Approximately 5 years ]
  3. Investigator-assessed objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  4. Median time to onset (Grades 3-4) of select adverse events [ Time Frame: Approximately 5 years ]
  5. Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: Approximately 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409368


  Hide Study Locations
Locations
Layout table for location information
United States, North Carolina
Southampton University Hospitals NHS Trust
Raleigh, North Carolina, United States, 27607
Austria
Local Institution
Salzburg, Austria, 5020
Local Institution
Wels, Austria, 4600
Local Institution
Wien, Austria, 1140
Denmark
Local Institution
Aalborg, Denmark, 9000
Local Institution
Herlev, Denmark, 2730
Local Institution
Odense C, Denmark, 5000
Finland
Local Institution
Oulu, Finland, 90220
Local Institution
Pori, Finland, FI-28500
Greece
Local Institution
Athens, Greece, 11527
Local Institution
Athens, Greece, 14564
Local Institution
Heraklion, Greece, 71110
Local Institution
Rio, Greece, 26504
Local Institution
Thessaloniki, Greece, 57010
Hungary
Local Institution
Budapest, Hungary, 1121
Local Institution
Debrecen, Hungary, 4032
Local Institution
Pecs, Hungary, 7624
Ireland
Local Institution
Dublin 8, Dublin, Ireland
Local Institution
Galway, Ireland, ST4 6QG
Poland
Local Institution
Gdansk, Poland, 80-214
Local Institution
Gliwice, Poland, 44-101
Instytut Medyczny Santa Familia Sp. z o.o.
Lodz, Poland, 90-302
Local Institution
Poznan, Poland, 60-693
Local Institution
Warszawa, Poland, 04-141
Local Institution
Zabrze, Poland, 41-803
Portugal
Local Institution
Coimbra, Portugal, 3000-602
Local Institution
Lisboa, Portugal, 1099-023
Local Institution
Lisboa, Portugal, 1769-001
Local Institution
Porto, Portugal, 4099-001
Local Institution
Porto, Portugal, 4200-072
Local Institution
Porto, Portugal, 4200-319
Romania
Local Institution
Bucharest, Romania, 022328
Local Institution
Bucharest, Romania, 030171
Local Institution
Cluj Napoca, Romania, 400058
Local Institution
Cluj-Napoca, Romania, 400015
Local Institution
Oradea, Romania, 410469
Local Institution
Timisoara, Romania, 300167
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Saint Petersburg, Russian Federation, 197758
Local Institution
St. Petersburg, Russian Federation, 198255
Spain
Local Institution
A Coruna, Spain, 15006
Local Institution
Alicante, Spain, ?03010
Local Institution
Barcelona, Spain, 08025
Local Institution
Barcelona, Spain, 08035
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 8916
Local Institution
Burgos, Spain, 09006
Local Institution
Granada, Spain, 18014
Local Institution
La Laguna, Spain, 38320
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28040
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28046
Local Institution
Malaga, Spain, 29010
Local Institution
Palma de Mallorca, Spain, 07198
Local Institution
Santander, Spain, 39008
Local Institution
Sevilla, Spain, 41013
Local Institution
Valencia, Spain, 46010
Local Institution
Valencia, Spain, 46026
Local Institution
Zaragoza, Spain, 50009
Sweden
Local Institution
Solna, Sweden, 17176
Local Institution
Stockholm, Sweden, SE-17176
United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Local Institution
Bristol, United Kingdom, BS2 8ED
Local Institution
Cardiff, United Kingdom, CF14 2TL
Local Institution
Cottingham, United Kingdom, HU16 5JQ
Local Institution
Glasgow, United Kingdom, G12 0YN
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
North Middlesex Hospital
London, United Kingdom, N18 1QX
Local Institution
London, United Kingdom, SW3 6JJ
Local Institution
London, United Kingdom, W6 8RF
Local Institution
London, United Kingdom, WC1E 6BT
Maidstone Hospital
Maidstone, United Kingdom, ME16 9QQ
Local Institution
Northwood, United Kingdom, HA6 2RN
Local Institution
Plymouth, United Kingdom, PL6 8DH
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Local Institution
Sheffield, United Kingdom, S10 5SJ
Local Institution
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Bristol-Myers Squibb
PPD
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02409368     History of Changes
Other Study ID Numbers: CA209-171
2014-001285-10 ( EudraCT Number )
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents