Overview
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
Status:
Withdrawn
Withdrawn
Trial end date:
2019-09-29
2019-09-29
Target enrollment:
0
0
Participant gender:
All
All
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 IpilimumabPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Antibodies, Monoclonal
Ipilimumab
Nivolumab
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit 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