Non-small cell lung cancer
Conditions
Interventions
Subjects will receive open-label treatment with nivolumab (flat dose of 240 mg
every two weeks) in combination with ipilimumab (1 mg/kg every 6 weeks). Both
nivolumab and ipilimumab are provided by
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: D4. Main inclusion criteria - Male and female patients over the age of 18 with ECOG status of 0-2 - Participants with histologically confirmed Stage IV (1st line NCSLC) or IIIB/IV (2nd line NSCLC) or recurrent, progressive NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease (1st line NSCLC) or with recurrent or progressive disease following multimodal therapy or platinum-doublet chemotherapy (2nd line NSCLC). Patients with untreated brain metastases, a controlled HIV infection, hepatic or renal impairment, or with a ECOG PS 2- Measurable disease by CT or MRI per RECIST 1.1. Participants must have tissue submitted for PD-L1 IHC testing prior to the treatment assignment. If PD-L1 IHC testing has already been conducted during screening for another BMS study, it does not need to be repeated for CA209-817. Women of childbearing potential must not be breastfeeding and must have a negative serum or urine pregnancy test within 24 hours prior to start of study treatment. This test will be repeated every 6 weeks during the study. Patients must follow the contraception requirements while enrolled in the study.
Exclusion criteria
Exclusion criteria: -Patients previously treated with drugs targeting T-cell co-stimulation or checkpoint pathways. Patients with known EGFR mutations or ALK translocations sensitive to available targeted inhibitor therapy. Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol. Patients with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of treatment assignment.. Patients with interstitial lung disease or, who are incarcerated or temporarily detained for psychiatric or physical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study will be assessed by summarizing the number and percentage of participants who experience high grade (Grade 3-4 and Grade 5) treatment-related select and immune-mediated adverse events. The select adverse events of interest are the following: - pneumonitis - interstitial nephritis - diarrhea/colitis - hepatitis - rash - endocrinopathies - hypersensitivity/infusion reaction events | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) - Objective Response Rate (ORR) - Overall survival (OS) - Duration of Response (DOR) * - Participant reported outcomes (PROs): assessment of changes in disease-related symptoms | — |
Countries
Netherlands
Outcome results
None listed