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

NCT02409368 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CA209-1712014-001285-10
• Study Type: interventional
• Target: 812
• Locations: 13 countries
• Sites: 90

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events

  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 Outcomes (5)

• Number of Participants With High Grade Select Adverse Events

  From first dose up to 100 days post last dose (up to 76 months)

• 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 Resolution of Any Grade Select Adverse Events

  From first dose to up to 100 days post last dose (up to approximately 45 months)

• Overall Survival

  From the first dosing up to the date of death (up to approximately 76 months)

• Objective Response Rate (ORR)

  From first dose up to last dose (up to approximately 76 months)

Study Arms (1)

Cohort A: Treatment - Nivolumab

EXPERIMENTAL

Nivolumab IV infusion

Drug: Nivolumab

Interventions

Nivolumab DRUG

Cohort A: Treatment - Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• PPD Development, LP: collaborator

Study Sites (90)

Local Institution - 0002

Wels, Upper Austria, 4600, Austria

Location

Local Institution - 0003

Salzburg, 5020, Austria

Location

Local Institution - 0005

Vienna, 1140, Austria

Location

Local Institution - 0173

Odense, Region Syddanmark, 5000, Denmark

Location

Local Institution - 0021

Aalborg, 9000, Denmark

Location

Local Institution - 0020

Herlev, 2730, Denmark

Location

Local Institution - 0022

Oulu, North Ostrobothnia, 90230, Finland

Location

Local Institution - 0023

Pori, FI-28500, Finland

Location

Local Institution - 0051

Athens, 11527, Greece

Location

Local Institution - 0052

Heraklion, 71110, Greece

Location

Local Institution - 0177

Nea Kifisia Athens, 14564, Greece

Location

Local Institution - 0148

Pátrai, 26504, Greece

Location

Local Institution - 0147

Thessaloniki, 57010, Greece

Location

Local Institution - 0054

Pécs, Baranya, 7624, Hungary

Location

Local Institution - 0053

Budapest, 1121, Hungary

Location

Local Institution - 0347

Budapest, 1125, Hungary

Location

Local Institution - 0178

Debrecen, 4032, Hungary

Location

Local Institution - 0056

Dublin, 0, Ireland

Location

Local Institution - 0058

Galway, ST4 6QG, Ireland

Location

Local Institution - 0349

Tullamore, Offaly, 0, Ireland

Location

Local Institution - 0087

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Local Institution - 0158

Gliwice, Silesian Voivodeship, 44-100, Poland

Location

Local Institution - 0184

Zabrze, Silesian Voivodeship, 41-803, Poland

Location

Local Institution - 0086

Gdansk, 80-214, Poland

Location

Local Institution - 0088

Lodz, 90-302, Poland

Location

Local Institution - 0089

Warsaw, 04-141, Poland

Location

Local Institution - 0094

Coimbra, 3000-602, Portugal

Location

Local Institution - 0093

Lisbon, 1099-023, Portugal

Location

Local Institution - 0090

Lisbon, 1769-001, Portugal

Location

Local Institution - 0092

Porto, 4099-001, Portugal

Location

Local Institution - 0091

Porto, 4200-072, Portugal

Location

Local Institution - 0159

Porto, 4200-319, Portugal

Location

Local Institution - 0192

Oradea, Bihor County, 410469, Romania

Location

Local Institution - 0098

Cluj-Napoca, Cluj, 400058, Romania

Location

Local Institution - 0187

Timișoara, Timiș County, 300167, Romania

Location

Local Institution - 0095

Bucharest, 022328, Romania

Location

Local Institution - 0096

Bucharest, 030171, Romania

Location

Local Institution - 0097

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0100

Saint Petersburg, Leningradskaya Oblast', 197758, Russia

Location

Local Institution - 0160

Moscow, Moscow, 115478, Russia

Location

Local Institution - 0099

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Local Institution - 0109

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0337

Oviedo, Principality of Asturias, 33006, Spain

Location

Local Institution - 0107

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Local Institution - 0104

A Coruña, 15006, Spain

Location

Local Institution - 0119

Alicante, 03010, Spain

Location

Local Institution - 0162

Barcelona, 08036, Spain

Location

Local Institution - 0112

Barcelona, 08916, Spain

Location

Local Institution - 0111

Barcelona, 8028, Spain

Location

Local Institution - 0110

Barcelona, 8035, Spain

Location

Local Institution - 0108

Burgos, 09006, Spain

Location

Local Institution - 0103

Granada, 18014, Spain

Location

Local Institution - 0114

Madrid, 28034, Spain

Location

Local Institution - 0117

Madrid, 28040, Spain

Location

Local Institution - 0116

Madrid, 28041, Spain

Location

Local Institution - 0105

Madrid, 28046, Spain

Location

Local Institution - 0106

Málaga, 29010, Spain

Location

Local Institution - 0113

Palma de Mallorca, 07198, Spain

Location

Local Institution - 0118

Seville, 41013, Spain

Location

Local Institution - 0161

Valencia, 46010, Spain

Location

Local Institution - 0102

Valencia, 46026, Spain

Location

Local Institution - 0163

Zaragoza, 50009, Spain

Location

Local Institution - 0346

Stockholm, Stockholm County, 17176, Sweden

Location

Local Institution - 0193

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Local Institution - 0348

Linköping, 581 85, Sweden

Location

Local Institution - 0342

Lund, 22185, Sweden

Location

Local Institution - 0120

Stockholm, 171 76, Sweden

Location

Local Institution - 0339

Örebro, Örebro County, SE-70185, Sweden

Location

Local Institution - 0345

Aberdeen, Aberdeen CITY, AB25 2ZN, United Kingdom

Location

Local Institution - 0127

London, Greater London, N18 1QX, United Kingdom

Location

Local Institution - 0191

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0131

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0128

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

Local Institution - 0195

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Local Institution - 0132

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Local Institution - 0167

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Local Institution - 0196

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Local Institution - 0171

Bebington, CH63 4JY, United Kingdom

Location

Local Institution - 0340

Bodelwyddan, Rhyl, LL18 5UJ, United Kingdom

Location

Local Institution - 0344

Bradford, BD9 6RJ, United Kingdom

Location

Local Institution - 0190

Bristol, BS2 8ED, United Kingdom

Location

Local Institution - 0133

Cardiff, CF14 2TL, United Kingdom

Location

Local Institution - 0126

Cottingham, HU16 5JQ, United Kingdom

Location

Local Institution - 0165

London, W1T 7HA, United Kingdom

Location

Local Institution - 0169

London, W6 8RF, United Kingdom

Location

Local Institution - 0194

Northwood, HA6 2RN, United Kingdom

Location

Local Institution - 0166

Plymouth, PL6 8DH, United Kingdom

Location

Local Institution - 0124

Sheffield, S10 5SJ, United Kingdom

Location

Local Institution - 0189

Sutton, SM2 5PT, United Kingdom

Location

Local Institution - 0338

West Midlands, CV2 2DX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32028209 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: April 29, 2015
• Primary Completion: March 7, 2018
• Study Completion: August 27, 2021
• Last Updated: November 14, 2022
• Results First Posted: July 29, 2021

Record last verified: 2022-10

Locations

ES (21); DK (3); SE (6); FI (2); PL (6); GR (5); HU (4); GB (22); AU (3); IE (3); RU (3); RO (6); PT (6)