Nivolumab + FOLFOX + Regorafenib for Esophageal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on systemic steroid therapy or any form of immunosuppressive therapy, you must stop these at least 7 days before starting the trial treatment.
What data supports the effectiveness of the drug combination Nivolumab, FOLFOX, and Regorafenib for esophageal cancer?
Research shows that adding Nivolumab to chemotherapy can improve survival in advanced esophageal and related cancers, and the combination of Nivolumab with oxaliplatin-based chemotherapy has shown a sustained antitumor effect. Additionally, the FOLFOX regimen has been effective in treating inoperable or metastatic esophageal cancer, with a response rate of 62.9% on the primary tumor.12345
Is the combination of Nivolumab, FOLFOX, and Regorafenib generally safe for humans?
Regorafenib, used in various cancers, has a manageable safety profile with common side effects like skin reactions, high blood pressure, fatigue, diarrhea, and liver issues. These side effects are usually mild to moderate and can be managed with dose adjustments and supportive care. Nivolumab, when combined with chemotherapy, has been studied for safety in advanced esophageal and related cancers, but specific safety data for this exact combination in esophageal cancer is limited.16789
How is the drug combination of Nivolumab, FOLFOX, and Regorafenib unique for treating esophageal cancer?
This drug combination is unique because it combines Nivolumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells, with FOLFOX chemotherapy and Regorafenib, a drug that targets multiple pathways involved in cancer growth. This approach aims to enhance the overall antitumor effect, especially in cases where standard treatments are limited.1291011
What is the purpose of this trial?
The purpose of this study is to find out whether combining nivolumab, FOLFOX, and regorafenib may be a safe and effective treatment for people who have HER2-negative metastatic esophagogastric cancer.Nivolumab is an antibody, like the proteins made by the immune system to protect the body from harm. Nivolumab blocks the protein PD-1 (programmed cell death receptor-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them.FOLFOX is a combination of three standard chemotherapy drugs (leucovorin, 5-fluorouracil, and oxaliplatin) commonly used to treat your type of cancer. The drugs work by damaging the DNA in cancer cells, which can cause the cells to stop growing and die.Regorafenib is a type of drug called a tyrosine kinase inhibitor (TKI). This drug targets the tyrosine kinase protein found in or on the surface of cancer cells that the cells need to survive and grow. Blocking this protein may stop cancer cells from growing, or cause them to grow more slowly or to shrink.The study researchers think that combining nivolumab, FOLFOX, and regorafenib may be a more effective treatment for HER2-negative metastatic esophagogastric cancer than the usual chemotherapy treatment(s) alone.
Research Team
Yelena Janjigian, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with HER2-negative metastatic esophagogastric cancer can join this trial. They should have adequate organ function, no severe neuropathy, and their disease must be visible on scans. Excluded are those with HER2-positive cancer, difficulty swallowing pills, recent major surgery or radiation, prior regorafenib treatment, certain autoimmune diseases unless specified exceptions apply, active infections like HIV or hepatitis B/C, uncontrolled heart conditions or blood pressure issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction therapy with regorafenib and nivolumab
Treatment
Participants receive nivolumab, FOLFOX, and regorafenib in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- FOLFOX chemotherapy with oxaliplatin
- Nivolumab
- Regorafenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania