Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Checked against the public recordLast updated Apr 5, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Biological: Nivolumab; Biological: Ipilimumab; Drug: Platinum Doublet Chemotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Men and Women ≥ 18 years of age * Diagnosed with stage IV Non-Small Cell Lung Cancer * Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options. Exclusion Criteria: * Subjects with untreated CNS metastases are excluded. * Subjects with carcinomatous meningitis * Subjects with an active, known or suspected autoimmune disease. * Subjects with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment. * Women who are pregnant, plan to become pregnant, and/or breastfeed during the study. Other protocol defined inclusion/exclusion criteria apply
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Sharp Memorial HospitalSan Diego, California
- Cancer Center Of Central ConnecticutPlainville, Connecticut
- Cleveland Clinic FloridaWeston, Florida
- Winship Cancer Institute.Atlanta, Georgia
- Summit Cancer CareSavannah, Georgia
- Cancer Center Of KansasWichita, Kansas
- University Of Louisville Medical Center, Inc., DbaLouisville, Kentucky
- Johns Hopkins Cancer CenterBaltimore, Maryland
- Local Institution - 0029Boston, Massachusetts
- Local Institution - 0030Boston, Massachusetts
- Massachusetts General HospitalBoston, Massachusetts
- Henry Ford Health SystemDetroit, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 5, 2023. Always confirm current availability with the study team.