NCT03425331

Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC

Biomarkers of Response to Ipilimumab and Nivolumab as First-line Therapy for Metastatic Non-small Cell Lung Cancer (NSCLC): an Open-label, Single Arm Phase 2 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC). The drugs involved in this study are: * Ipilimumab * Nivolumab

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administration) has not approved ipilimumab for this specific disease but it has been approved for other uses, including for patients with advanced melanoma. The FDA (the U.S. Food and Drug Administration) has approved nivolumab as a treatment option for this disease. However, nivolumab it is not approved in combination with ipilimumab to treat NSCLC. Nivolumab and ipilimumab are both types of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells. The combination of ipilimumab with nivolumab may or may not increase anti-cancer activity by further boosting the immune system. In this research study, the investigators are investigating if the combination of ipilimumab and nivolumab is effective in treating advanced NSCLC. The investigators are also investigating whether there are certain DNA or protein markers in the blood or tumor tissue that may indicate whether the combination will work in future patients.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells
DRUG	Nivolumab	Nivolumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells

Timeline

• Start date: 2018-04-10
• Primary completion: 2020-05-18
• Completion: 2021-11-28
• First posted: 2018-02-07
• Last updated: 2026-01-08
• Results posted: 2024-08-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study