A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 1) Stage IV or recurrent non-Small cell lung cancer 2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization Exclusion Criteria: 1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy 2) Active, known or suspected autoimmune disease or HIV infection 3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) 4) Untreated Central Nervous System metastases Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flat-Dose<br>Nivolumab flat dose + Ipilimumab | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Weight-Based Dose<br>Nivolumab weight-based dose + Ipilimumab | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events |  | Approximately 3 months | 
| Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events |  | Approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |