A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
- Registration Number
- NCT03048136
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
- Detailed Description
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-
- Stage IV or recurrent non-Small cell lung cancer
-
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
-
- Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Exclusion Criteria
-
- Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
-
- Active, known or suspected autoimmune disease or HIV infection
-
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
-
- Untreated Central Nervous System metastases
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight-Based Dose Nivolumab Nivolumab weight-based dose + Ipilimumab Flat-Dose Nivolumab Nivolumab flat dose + Ipilimumab Flat-Dose Ipilimumab Nivolumab flat dose + Ipilimumab Weight-Based Dose Ipilimumab Nivolumab weight-based dose + Ipilimumab
- Primary Outcome Measures
Name Time Method Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events Approximately 3 months Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events Approximately 3 months
- Secondary Outcome Measures
Name Time Method Overall survival (OS) as defined as the time from first dosing to the date of death Up to 5 years Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to 24 months Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to 24 months Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to 24 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Nivolumab and Ipilimumab synergy in PD-1/CTLA-4 checkpoint inhibition for NSCLC in CheckMate 955?
How does Nivolumab plus Ipilimumab compare to standard-of-care chemotherapy in chemotherapy-naive Stage IV NSCLC patients in CheckMate 955?
Which PD-L1 expression levels or tumor mutational burden (TMB) biomarkers correlate with response to Nivolumab-Ipilimumab in CheckMate 955 NSCLC?
What immune-related adverse events (irAEs) are reported with Nivolumab and Ipilimumab in CheckMate 955, and how are they managed in NSCLC patients?
How does the Nivolumab-Ipilimumab combination in CheckMate 955 (Bristol-Myers Squibb) compare to pembrolizumab-based dual immunotherapy in advanced NSCLC?
Trial Locations
- Locations (1)
Local Institution
🇵🇪Lima, Peru