An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monot... | Not Recruiting
An Open-Label, Multicenter Clinical... | Not Recruiting
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

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Medical Conditions
  • Non-Small Cell Lung Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02409368
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Nivolumab

Study Arm Groups : Cohort A: Treatment - Nivolumab

Intervention Type
See Interventions above
Primary Outcome Measures
    Incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in subjects with advanced or metastatic SqNSCLC; Approximately 5 years
Secondary Outcome Measures
    Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events; Approximately 5 years; Overall survival (OS) in all treated subject; Approximately 5 years; Investigator-assessed objective response rate (ORR); Approximately 3 years; Median time to onset (Grades 3-4) of select adverse events; Approximately 5 years; Median time to resolution (Grades 3-4) of select adverse events; Approximately 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
800
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Maidstone Hospital
Maidstone
England
ME16 9QQ
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Rosemere Cancer Centre at Royal Preston Hospital
Fulwood
England
PR2 9HT
Plymouth
PL6 8DH
Kennedy Institute Clinical Trials Unit, 4Wl, Charing Cross Hospital
London
W6 8RF
London
WC1E 6BT
Bristol
BS2 8ED
Pfizer Investigational Site
Cardiff
Cardiff
CF14 2TL
GSK Investigational Site
Cottingham
HU16 5JQ
Sheffield
S10 2SJ
Glasgow
G12 0YN
North Middlesex NHS Trust
London
N18 1QX
The Clatterbridge Cancer Centre NHS Foundation Trust
Birkenhead
CH63 4JY
Local Institution
Sutton
Surrey
SM25PT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Denmark, Finland, Greece, Hungary, Ireland, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • PPD
Other Study ID Numbers
CA209-171
Sponsor(s)
Bristol-Myers Squibb
Key Dates

Recruitment Start Date

Apr 2015

Recruitment End Date

May 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

01 Apr 2015

Date updated in source

14 Sep 2017