NCT04043195

Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLC

Nivolumab (Anti-PD1 Antibody) and Ipilimumab (Anti-CTLA4 Antibody) in Combination With Immunogenic Chemotherapy for Patients With Advanced Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hatim Husain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system).

Detailed description

The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system). Nivolumab (Opdivo®) is approved by the Food and Drug Administration (FDA) for the treatment of metastatic (the cancer has spread) NSCLC. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies bind to other proteins, such as PD-1 (programmed cell death-1), on immune cells, which allows the immune cells to continue working against the tumor. Ipilumumab (Yervoy®) is also a monoclonal antibody, but binds to a protein called CTLA-4 (cytotoxic T-lymphocyte-associated protein 4). Oxaliplatin is a type of immunogenic chemotherapy, which may increase the body's immune response to the cancer. Both are approved for treatment of other types of cancers, but not in patients with NSCLC.

Conditions

• Advanced NSCLC

Interventions

Type	Name	Description
DRUG	Nivolumab	240 mg every 2 weeks. Nivolumab will continue for up to 2 years.
DRUG	Oxaliplatin	65 mg/m2 every 2 weeks. Oxaliplatin will continue for up to 12 cycles.
DRUG	Ipilimumab	1 mg/kg every 6 weeks. Ipilimumab will continue for up to 4 cycles

Timeline

• Start date: 2019-08-14
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2019-08-02
• Last updated: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study