Clinical trial NCT02409368: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2015-04-06
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
timeFrame: From first dose to time of analysis of primary endpoint (approximately up to 34 months)
Secondary outcomes:
measure: Number of Participants With High Grade Select Adverse Events
timeFrame: From first dose up to 100 days post last dose (up to 76 months)
measure: Median Time to Onset of Any Grade Select Adverse Events
timeFrame: From first dose up to 100 days post last dose (up to approximately 65 months)
measure: Median Time to Resolution of Any Grade Select Adverse Events
timeFrame: From first dose to up to 100 days post last dose (up to approximately 45 months)
measure: Overall Survival
timeFrame: From the first dosing up to the date of death (up to approximately 76 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dose up to last dose (up to approximately 76 months)
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Local Institution - 0002
state: Oberösterreich
city: Salzburg
country: Austria
facility: Local Institution - 0003
city: Wien
country: Austria
facility: Local Institution - 0005
city: Odense
country: Denmark
facility: Local Institution - 0173
state: South Denmark
city: Aalborg
country: Denmark
facility: Local Institution - 0021
city: Herlev
country: Denmark
facility: Local Institution - 0020
city: Oulu
country: Finland
facility: Local Institution - 0022
state: Pohjois-Pohjanmaa
city: Pori
country: Finland
facility: Local Institution - 0023
city: Athens
country: Greece
facility: Local Institution - 0051
city: Heraklion
country: Greece
facility: Local Institution - 0052
city: Nea Kifisia Athens
country: Greece
facility: Local Institution - 0177
city: Patras
country: Greece
facility: Local Institution - 0148
city: Thessaloniki
country: Greece
facility: Local Institution - 0147
city: Pécs
country: Hungary
facility: Local Institution - 0054
state: Baranya
city: Budapest
country: Hungary
facility: Local Institution - 0053
city: Budapest
country: Hungary
facility: Local Institution - 0347
city: Debrecen
country: Hungary
facility: Local Institution - 0178
city: Dublin 8
country: Ireland
facility: Local Institution - 0056
city: Galway
country: Ireland
facility: Local Institution - 0058
city: Tullamore, Offaly
country: Ireland
facility: Local Institution - 0349
city: Gliwice
country: Poland
facility: Local Institution - 0158
state: Slaskie
city: Zabrze
country: Poland
facility: Local Institution - 0184
state: Slaskie
city: Poznan
country: Poland
facility: Local Institution - 0087
state: Wielkopolskie
city: Gdansk
country: Poland
facility: Local Institution - 0086
city: Lodz
country: Poland
facility: Local Institution - 0088
city: Warszawa
country: Poland
facility: Local Institution - 0089
city: Coimbra
country: Portugal
facility: Local Institution - 0094
city: Lisboa
country: Portugal
facility: Local Institution - 0093
city: Lisboa
country: Portugal
facility: Local Institution - 0090
city: Porto
country: Portugal
facility: Local Institution - 0092
city: Porto
country: Portugal
facility: Local Institution - 0091
city: Porto
country: Portugal
facility: Local Institution - 0159
city: Oradea
country: Romania
facility: Local Institution - 0192
state: Bihor
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0098
state: Cluj
city: Timisoara
country: Romania
facility: Local Institution - 0187
state: Timis
city: Bucharest
country: Romania
facility: Local Institution - 0095
city: Bucharest
country: Romania
facility: Local Institution - 0096
city: Cluj Napoca
country: Romania
facility: Local Institution - 0097
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 0100
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: Local Institution - 0160
state: Moskva
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0099
state: Sankt-Peterburg
city: Oviedo
country: Spain
facility: Local Institution - 0337
state: Asturias
city: Santander
country: Spain
facility: Local Institution - 0109
state: Cantabria
city: La Laguna
country: Spain
facility: Local Institution - 0107
state: Santa Cruz De Tenerife
city: A Coruna
country: Spain
facility: Local Institution - 0104
city: Alicante
country: Spain
facility: Local Institution - 0119
city: Barcelona
country: Spain
facility: Local Institution - 0162
city: Barcelona
country: Spain
facility: Local Institution - 0112
city: Barcelona
country: Spain
facility: Local Institution - 0111
city: Barcelona
country: Spain
facility: Local Institution - 0110
city: Burgos
country: Spain
facility: Local Institution - 0108
city: Granada
country: Spain
facility: Local Institution - 0103
city: Madrid
country: Spain
facility: Local Institution - 0114
city: Madrid
country: Spain
facility: Local Institution - 0117
city: Madrid
country: Spain
facility: Local Institution - 0116
city: Madrid
country: Spain
facility: Local Institution - 0105
city: Malaga
country: Spain
facility: Local Institution - 0106
city: Palma de Mallorca
country: Spain
facility: Local Institution - 0113
city: Seville
country: Spain
facility: Local Institution - 0118
city: Valencia
country: Spain
facility: Local Institution - 0161
city: Valencia
country: Spain
facility: Local Institution - 0102
city: Zaragoza
country: Spain
facility: Local Institution - 0163
city: Örebro
country: Sweden
facility: Local Institution - 0339
state: Orebro Lan
city: Stockholm
country: Sweden
facility: Local Institution - 0346
state: Stockholms Lan
city: Goteborg
country: Sweden
facility: Local Institution - 0193
state: Vastra Gotalands Lan
city: Linköping
country: Sweden
facility: Local Institution - 0348
city: Lund
country: Sweden
facility: Local Institution - 0342
city: Stockholm
country: Sweden
facility: Local Institution - 0120
city: Aberdeen
country: United Kingdom
facility: Local Institution - 0345
state: Aberdeen CITY
city: London
country: United Kingdom
facility: Local Institution - 0127
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0191
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: Local Institution - 0131
state: Hampshire
city: Maidstone
country: United Kingdom
facility: Local Institution - 0128
state: Kent
city: Glasgow
country: United Kingdom
facility: Local Institution - 0195
state: Lanarkshire
city: Preston
country: United Kingdom
facility: Local Institution - 0132
state: Lancashire
city: Leicester
country: United Kingdom
facility: Local Institution - 0167
state: Leicestershire
city: Sutton
country: United Kingdom
facility: Local Institution - 0196
state: Surrey
city: Bebington
country: United Kingdom
facility: Local Institution - 0171
city: Bodelwyddan, Rhyl
country: United Kingdom
facility: Local Institution - 0340
city: Bradford
country: United Kingdom
facility: Local Institution - 0344
city: Bristol
country: United Kingdom
facility: Local Institution - 0190
city: Cardiff
country: United Kingdom
facility: Local Institution - 0133
city: Cottingham
country: United Kingdom
facility: Local Institution - 0126
city: London
country: United Kingdom
facility: Local Institution - 0165
city: London
country: United Kingdom
facility: Local Institution - 0169
city: Northwood
country: United Kingdom
facility: Local Institution - 0194
city: Plymouth
country: United Kingdom
facility: Local Institution - 0166
city: Sheffield
country: United Kingdom
facility: Local Institution - 0124
city: Sutton
country: United Kingdom
facility: Local Institution - 0189
city: West Midlands
country: United Kingdom
facility: Local Institution - 0338
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.