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Report for Clinical Trial NCT02066636

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02066636 Non Small Cell Lung Cancer (NSCLC)
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Nivolumab

Type: Drug
Group Labels: 2

Cohort A: Nivolumab Cohort B: Nivolumab


Primary Outcomes

Measure: Incidence for high grade (Grade 3-4 and Grade 5) treatment related select adverse events (AEs)

Time: 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: Up to 100 days after last dose date (approximately up to 6.5 years)

Measure: Median time to onset and median time to resolution (Grade 3-4)

Time: Up to 100 days after last dose date (approximately up to 6.5 years)

Description: Immune modulating medication (e.g. corticosteroids, Infliximab, Cyclophosphamide, intravenous immune globulin (IVIG), and Mycophenolate Mofetil)

Measure: 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: Up to 100 days after last dose date (approximately up to 6.5 years)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

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. --- L858R ---



HPO Nodes


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