NCI-2022-08569

Randomized Phase III Trial of mFOLFIRINOX /- Nivolumab vs. FOLFOX /- Nivolumab for First-Line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma

This randomized Phase III research study is comparing two chemotherapy-based treatment regimens—mFOLFIRINOX ± nivolumab and FOLFOX ± nivolumab—as first-line therapy for patients with metastatic HER2-negative gastroesophageal adenocarcinoma (a type of cancer that starts in the stomach or the junction where the esophagus meets the stomach and has spread to other parts of the body). Nivolumab, an immunotherapy checkpoint inhibitor, blocks the PD-1 receptor on immune cells, helping the immune system recognize and attack cancer cells more effectively. This study seeks to define the optimal first-line treatment strategy for patients with metastatic HER2-negative gastroesophageal adenocarcinoma, a group for whom standard options remain limited.

Phase 3: A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Randomized: Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

Check point inhibitor: The immune system can help fight cancer. Drugs called “checkpoint inhibitors” work by releasing a natural brake on your immune system so that immune cells can recognize and attack tumors.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT05677490

Clinical Trial Site: Einstein

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