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

Non-Small Cell Lung Cancer Clinical Trial

— Checkmate 171  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409368
• Other study ID #: CA209-171
• Secondary ID: 2014-001285-10
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2015
• Est. completion date: August 27, 2021

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: August 27, 2021
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Nivolumab

Locations

Country	Name	City	State
Austria	Local Institution - 0003	Salzburg
Austria	Local Institution - 0002	Wels	Oberösterreich
Austria	Local Institution - 0005	Wien
Denmark	Local Institution - 0021	Aalborg
Denmark	Local Institution - 0020	Herlev
Denmark	Local Institution - 0173	Odense	South Denmark
Finland	Local Institution - 0022	Oulu	Pohjois-Pohjanmaa
Finland	Local Institution - 0023	Pori
Greece	Local Institution - 0051	Athens
Greece	Local Institution - 0052	Heraklion
Greece	Local Institution - 0177	Nea Kifisia Athens
Greece	Local Institution - 0148	Patras
Greece	Local Institution - 0147	Thessaloniki
Hungary	Local Institution - 0053	Budapest
Hungary	Local Institution - 0347	Budapest
Hungary	Local Institution - 0178	Debrecen
Hungary	Local Institution - 0054	Pécs	Baranya
Ireland	Local Institution - 0056	Dublin 8
Ireland	Local Institution - 0058	Galway
Ireland	Local Institution - 0349	Tullamore, Offaly
Poland	Local Institution - 0086	Gdansk
Poland	Local Institution - 0158	Gliwice	Slaskie
Poland	Local Institution - 0088	Lodz
Poland	Local Institution - 0087	Poznan	Wielkopolskie
Poland	Local Institution - 0089	Warszawa
Poland	Local Institution - 0184	Zabrze	Slaskie
Portugal	Local Institution - 0094	Coimbra
Portugal	Local Institution - 0090	Lisboa
Portugal	Local Institution - 0093	Lisboa
Portugal	Local Institution - 0091	Porto
Portugal	Local Institution - 0092	Porto
Portugal	Local Institution - 0159	Porto
Romania	Local Institution - 0095	Bucharest
Romania	Local Institution - 0096	Bucharest
Romania	Local Institution - 0097	Cluj Napoca
Romania	Local Institution - 0098	Cluj-Napoca	Cluj
Romania	Local Institution - 0192	Oradea	Bihor
Romania	Local Institution - 0187	Timisoara	Timis
Russian Federation	Local Institution - 0160	Moscow	Moskva
Russian Federation	Local Institution - 0100	Saint Petersburg	Leningradskaya Oblast
Russian Federation	Local Institution - 0099	St. Petersburg	Sankt-Peterburg
Spain	Local Institution - 0104	A Coruna
Spain	Local Institution - 0119	Alicante
Spain	Local Institution - 0110	Barcelona
Spain	Local Institution - 0111	Barcelona
Spain	Local Institution - 0112	Barcelona
Spain	Local Institution - 0162	Barcelona
Spain	Local Institution - 0108	Burgos
Spain	Local Institution - 0103	Granada
Spain	Local Institution - 0107	La Laguna	Santa Cruz De Tenerife
Spain	Local Institution - 0105	Madrid
Spain	Local Institution - 0114	Madrid
Spain	Local Institution - 0116	Madrid
Spain	Local Institution - 0117	Madrid
Spain	Local Institution - 0106	Malaga
Spain	Local Institution - 0337	Oviedo	Asturias
Spain	Local Institution - 0113	Palma de Mallorca
Spain	Local Institution - 0109	Santander	Cantabria
Spain	Local Institution - 0118	Seville
Spain	Local Institution - 0102	Valencia
Spain	Local Institution - 0161	Valencia
Spain	Local Institution - 0163	Zaragoza
Sweden	Local Institution - 0193	Goteborg	Vastra Gotalands Lan
Sweden	Local Institution - 0348	Linköping
Sweden	Local Institution - 0342	Lund
Sweden	Local Institution - 0339	Örebro	Orebro Lan
Sweden	Local Institution - 0120	Stockholm
Sweden	Local Institution - 0346	Stockholm	Stockholms Lan
United Kingdom	Local Institution - 0345	Aberdeen	Aberdeen CITY
United Kingdom	Local Institution - 0171	Bebington
United Kingdom	Local Institution - 0340	Bodelwyddan, Rhyl
United Kingdom	Local Institution - 0344	Bradford
United Kingdom	Local Institution - 0190	Bristol
United Kingdom	Local Institution - 0133	Cardiff
United Kingdom	Local Institution - 0126	Cottingham
United Kingdom	Local Institution - 0195	Glasgow	Lanarkshire
United Kingdom	Local Institution - 0167	Leicester	Leicestershire
United Kingdom	Local Institution - 0127	London	Greater London
United Kingdom	Local Institution - 0165	London
United Kingdom	Local Institution - 0169	London
United Kingdom	Local Institution - 0128	Maidstone	Kent
United Kingdom	Local Institution - 0191	Manchester	Greater Manchester
United Kingdom	Local Institution - 0194	Northwood
United Kingdom	Local Institution - 0166	Plymouth
United Kingdom	Local Institution - 0132	Preston	Lancashire
United Kingdom	Local Institution - 0124	Sheffield
United Kingdom	Local Institution - 0131	Southampton	Hampshire
United Kingdom	Local Institution - 0189	Sutton
United Kingdom	Local Institution - 0196	Sutton	Surrey
United Kingdom	Local Institution - 0338	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	PPD

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  Greece,  Hungary,  Ireland,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With High Grade Select Adverse Events	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.	From first dose up to 100 days post last dose (up to 76 months)
Secondary	Median Time to Onset of Any Grade Select Adverse Events	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.	From first dose up to 100 days post last dose (up to approximately 65 months)
Secondary	Median Time to Resolution of Any Grade Select Adverse Events	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.	From first dose to up to 100 days post last dose (up to approximately 45 months)
Secondary	Overall Survival	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.	From the first dosing up to the date of death (up to approximately 76 months)
Secondary	Objective Response Rate (ORR)	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.	From first dose up to last dose (up to approximately 76 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting