Overview

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

Status:
Withdrawn
Trial end date:
2019-09-29
Target enrollment:
0
Participant gender:
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 Ipilimumab
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Antibodies, Monoclonal
Ipilimumab
Nivolumab
Criteria
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