An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Purpose
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.
Condition
- Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed Stage 4 or recurrent non-small cell lung cancer - Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer) - No prior systemic anticancer therapy (including EGFR and ALK inhibitors) - Tissue or Programmed death-ligand 1 (PD-L1) results available Cohort 1A Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) score 2 or - Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol Cohort C Inclusion Criteria: - High Tumor Mutation Burden
Exclusion Criteria
- Untreated brain metastases - An active malignancy that requires concurrent intervention - Active, known or suspected autoimmune disease - Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer Other protocol-defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nivolumab in combination with Ipilimumab |
Specified dose on specified days |
|
Recruiting Locations
More Details
- NCT ID
- NCT02869789
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb