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
- Registration Number
- NCT02409368
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 812
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort A: Treatment - Nivolumab Nivolumab Nivolumab IV infusion
- Primary Outcome Measures
Name Time Method Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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.
Number of Participants With High Grade Select Adverse Events 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.
Median Time to Onset of Any Grade Select Adverse Events 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.
Median Time to Resolution of Any Grade Select Adverse Events 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.
Overall Survival 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.
Trial Locations
- Locations (90)
Local Institution - 0005
🇦🇹Wien, Austria
Local Institution - 0092
🇵🇹Porto, Portugal
Local Institution - 0003
🇦🇹Salzburg, Austria
Local Institution - 0093
🇵🇹Lisboa, Portugal
Local Institution - 0022
🇫🇮Oulu, Pohjois-Pohjanmaa, Finland
Local Institution - 0002
🇦🇹Wels, Oberösterreich, Austria
Local Institution - 0051
🇬🇷Athens, Greece
Local Institution - 0347
ðŸ‡ðŸ‡ºBudapest, Hungary
Local Institution - 0091
🇵🇹Porto, Portugal
Local Institution - 0095
🇷🇴Bucharest, Romania
Local Institution - 0109
🇪🇸Santander, Cantabria, Spain
Local Institution - 0104
🇪🇸A Coruna, Spain
Local Institution - 0102
🇪🇸Valencia, Spain
Local Institution - 0133
🇬🇧Cardiff, United Kingdom
Local Institution - 0166
🇬🇧Plymouth, United Kingdom
Local Institution - 0124
🇬🇧Sheffield, United Kingdom
Local Institution - 0338
🇬🇧West Midlands, United Kingdom
Local Institution - 0128
🇬🇧Maidstone, Kent, United Kingdom
Local Institution - 0345
🇬🇧Aberdeen, Aberdeen CITY, United Kingdom
Local Institution - 0194
🇬🇧Northwood, United Kingdom
Local Institution - 0173
🇩🇰Odense, South Denmark, Denmark
Local Institution - 0021
🇩🇰Aalborg, Denmark
Local Institution - 0020
🇩🇰Herlev, Denmark
Local Institution - 0023
🇫🇮Pori, Finland
Local Institution - 0148
🇬🇷Patras, Greece
Local Institution - 0052
🇬🇷Heraklion, Greece
Local Institution - 0177
🇬🇷Nea Kifisia Athens, Greece
Local Institution - 0147
🇬🇷Thessaloniki, Greece
Local Institution - 0054
ðŸ‡ðŸ‡ºPécs, Baranya, Hungary
Local Institution - 0053
ðŸ‡ðŸ‡ºBudapest, Hungary
Local Institution - 0178
ðŸ‡ðŸ‡ºDebrecen, Hungary
Local Institution - 0058
🇮🇪Galway, Ireland
Local Institution - 0349
🇮🇪Tullamore, Offaly, Ireland
Local Institution - 0056
🇮🇪Dublin 8, Ireland
Local Institution - 0158
🇵🇱Gliwice, Slaskie, Poland
Local Institution - 0184
🇵🇱Zabrze, Slaskie, Poland
Local Institution - 0087
🇵🇱Poznan, Wielkopolskie, Poland
Local Institution - 0086
🇵🇱Gdansk, Poland
Local Institution - 0089
🇵🇱Warszawa, Poland
Local Institution - 0094
🇵🇹Coimbra, Portugal
Local Institution - 0088
🇵🇱Lodz, Poland
Local Institution - 0090
🇵🇹Lisboa, Portugal
Local Institution - 0159
🇵🇹Porto, Portugal
Local Institution - 0098
🇷🇴Cluj-Napoca, Cluj, Romania
Local Institution - 0192
🇷🇴Oradea, Bihor, Romania
Local Institution - 0187
🇷🇴Timisoara, Timis, Romania
Local Institution - 0097
🇷🇴Cluj Napoca, Romania
Local Institution - 0096
🇷🇴Bucharest, Romania
Local Institution - 0100
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
Local Institution - 0160
🇷🇺Moscow, Moskva, Russian Federation
Local Institution - 0099
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Local Institution - 0337
🇪🇸Oviedo, Asturias, Spain
Local Institution - 0107
🇪🇸La Laguna, Santa Cruz De Tenerife, Spain
Local Institution - 0162
🇪🇸Barcelona, Spain
Local Institution - 0119
🇪🇸Alicante, Spain
Local Institution - 0112
🇪🇸Barcelona, Spain
Local Institution - 0111
🇪🇸Barcelona, Spain
Local Institution - 0110
🇪🇸Barcelona, Spain
Local Institution - 0108
🇪🇸Burgos, Spain
Local Institution - 0103
🇪🇸Granada, Spain
Local Institution - 0114
🇪🇸Madrid, Spain
Local Institution - 0117
🇪🇸Madrid, Spain
Local Institution - 0106
🇪🇸Malaga, Spain
Local Institution - 0113
🇪🇸Palma de Mallorca, Spain
Local Institution - 0118
🇪🇸Seville, Spain
Local Institution - 0161
🇪🇸Valencia, Spain
Local Institution - 0163
🇪🇸Zaragoza, Spain
Local Institution - 0346
🇸🇪Stockholm, Stockholms Lan, Sweden
Local Institution - 0348
🇸🇪Linköping, Sweden
Local Institution - 0339
🇸🇪Örebro, Orebro Lan, Sweden
Local Institution - 0193
🇸🇪Goteborg, Vastra Gotalands Lan, Sweden
Local Institution - 0342
🇸🇪Lund, Sweden
Local Institution - 0120
🇸🇪Stockholm, Sweden
Local Institution - 0191
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0127
🇬🇧London, Greater London, United Kingdom
Local Institution - 0131
🇬🇧Southampton, Hampshire, United Kingdom
Local Institution - 0132
🇬🇧Preston, Lancashire, United Kingdom
Local Institution - 0196
🇬🇧Sutton, Surrey, United Kingdom
Local Institution - 0167
🇬🇧Leicester, Leicestershire, United Kingdom
Local Institution - 0195
🇬🇧Glasgow, Lanarkshire, United Kingdom
Local Institution - 0171
🇬🇧Bebington, United Kingdom
Local Institution - 0344
🇬🇧Bradford, United Kingdom
Local Institution - 0190
🇬🇧Bristol, United Kingdom
Local Institution - 0340
🇬🇧Bodelwyddan, Rhyl, United Kingdom
Local Institution - 0126
🇬🇧Cottingham, United Kingdom
Local Institution - 0169
🇬🇧London, United Kingdom
Local Institution - 0165
🇬🇧London, United Kingdom
Local Institution - 0189
🇬🇧Sutton, United Kingdom
Local Institution - 0116
🇪🇸Madrid, Spain
Local Institution - 0105
🇪🇸Madrid, Spain