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)

• ClinicalTrials.gov Identifier: NCT02409368
• Recruitment Status: Completed
• First Posted: April 6, 2015
• Results First Posted: July 29, 2021
• Last Update Posted: November 14, 2022
• Sponsor: Bristol-Myers Squibb
• Collaborator: PPD
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: April 1, 2015
• First Posted Date: April 6, 2015
• Results First Submitted Date: March 31, 2021
• Results First Posted Date: July 29, 2021
• Last Update Posted Date: November 14, 2022
• Actual Study Start Date: April 29, 2015
• Actual Primary Completion Date: March 7, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 9, 2021)

Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: April 3, 2015): Incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in subjects with advanced or metastatic SqNSCLC [ Time Frame: Approximately 3 years ]

Current Secondary Outcome Measures (submitted: October 17, 2022)

• Number of Participants With High Grade Select Adverse Events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
• Objective Response Rate (ORR) [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: April 3, 2015)

• Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events [ Time Frame: Approximately 3 years ]
• Overall survival (OS) in all treated subject [ Time Frame: Approximately 5 years ]
• Investigator-assessed objective response rate (ORR) [ Time Frame: Approximately 3 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Non-Small Cell Lung Cancer
• Intervention: Drug: Nivolumab

Study Arms

Experimental: Cohort A: Treatment - Nivolumab

Nivolumab IV infusion

Intervention: Drug: Nivolumab

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 17, 2022): 812
• Original Estimated Enrollment (submitted: April 3, 2015): 1482
• Actual Study Completion Date: August 27, 2021
• Actual Primary Completion Date: March 7, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Denmark, Finland, Greece, Hungary, Ireland, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, United Kingdom
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT02409368
• Other Study ID Numbers: CA209-171; 2014-001285-10 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: PPD

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: October 2022