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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Trial Status: complete
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02869789.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute