Overview

This trial is active, not recruiting.

Condition non small cell lung cancer (nsclc)
Treatment nivolumab
Phase phase 3
Target PD-1
Sponsor Bristol-Myers Squibb
Start date February 2014
End date January 2023
Trial size 1380 participants
Trial identifier NCT02066636, CA209-153

Summary

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Nivolumab 3 mg/kg solution intravenous infusion over 60 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent
nivolumab BMS-936558
(Experimental)
Nivolumab 3 mg/kg solution intravenous infusion over 60 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed
nivolumab BMS-936558

Primary Outcomes

Measure
Incidence for high grade (Grade 3-4 and Grade 5) treatment related select adverse events (AEs)
time frame: Up to 100 days after last dose date (approximately up to 6.5 years)

Secondary Outcomes

Measure
Incidence for high grade (Grade 3-4 and Grade 5) select AEs
time frame: Up to 100 days after last dose date (approximately up to 6.5 years)
Median time to onset and median time to resolution (Grade 3-4)
time frame: Up to 100 days after last dose date (approximately up to 6.5 years)
Percentage of subjects who received immune modulating medication or hormonal replacement therapy, percentage of subjects who received ≥40 mg Prednisone equivalents, total duration of all immune modulating medications given for select event
time frame: Up to 100 days after last dose date (approximately up to 6.5 years)

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 1. Target Population - Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease) - Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease - Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy - Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy - Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible - Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible - Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy - Experimental therapies when given as separate regimen are considered as separate line of therapy - Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1 - Eastern Cooperative Oncology Arm (ECOG) performance status (PS) - PS 0 to 1 - PS 2 Exclusion Criteria: 1. Target Disease Exceptions - Subjects with active central nervous system (CNS) metastases are excluded - Subjects with carcinomatous meningitis 2. Medical History and Concurrent Diseases - Subjects with a history of interstitial lung disease - Subjects with active, known or suspected autoimmune disease - Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents 3. Prohibited Treatments and/or Restricted Therapies - Ongoing or planned administration of anti-cancer therapies other than those specified in this study - Use of corticosteroids or other immunosuppressive medications

Additional Information

Official title A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.