Nivolumab for Esophageal Cancer
(CheckMate 577 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Nivolumab, a type of medication, can help people with esophageal cancer live longer without the disease returning. Participants will receive either Nivolumab or a placebo (a substance with no active drug) to compare outcomes. The trial seeks individuals with Stage II or III esophageal cancer who have undergone chemo and radiation before surgery and still have some cancer cells remaining after surgery. Meeting these criteria and participating in this trial offers a chance to contribute to advancing cancer treatment. As a Phase 3 trial, this study represents the final step before FDA approval, providing a significant opportunity to be part of potentially groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that nivolumab, a medicine used to treat esophageal cancer, is generally well-tolerated. In earlier research, some patients experienced serious side effects, such as fever, diarrhea, and anemia (a condition characterized by a lack of healthy red blood cells). However, these side effects occurred in less than 4% of patients, indicating that while risks exist, serious side effects are uncommon.
Nivolumab has already received approval for treating certain types of cancer, which provides some confidence in its safety. However, like any treatment, it can have side effects, so consulting a healthcare provider is important to determine if it is appropriate.12345Why do researchers think this study treatment might be promising?
Nivolumab is unique because it offers a new way to tackle esophageal cancer by harnessing the power of the immune system. Unlike traditional chemotherapy and radiation, which directly target cancer cells, nivolumab is an immunotherapy that blocks a protein called PD-1, effectively releasing the brakes on the immune system and allowing it to attack cancer cells more vigorously. Researchers are excited about nivolumab because it has the potential to improve outcomes for patients by providing a more targeted approach with possibly fewer side effects compared to conventional treatments.
What evidence suggests that Nivolumab might be an effective treatment for esophageal cancer?
Research has shown that nivolumab, which participants in this trial may receive, yields promising results for treating esophageal cancer. In some studies, patients who received nivolumab experienced better outcomes and lived longer than those who only underwent chemotherapy. Specifically, when combined with chemotherapy, nivolumab led to cancer shrinking or disappearing in 60% of patients, compared to 40% with chemotherapy alone. This indicates that more patients experienced a reduction in their cancer. Additionally, patients lived longer on average when treated with both nivolumab and chemotherapy. These findings suggest that nivolumab could be a beneficial option for improving outcomes in esophageal cancer.46789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for people who've had surgery for Stage II/III esophageal or gastroesophageal junction cancer and still have some signs of the disease. They must have finished chemo radiotherapy before surgery. It's not open to those with other conditions that could interfere.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Nivolumab or placebo to assess disease-free survival
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Placebo
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead 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
Ono Pharmaceutical Co. Ltd
Industry Sponsor
Shinji Takai
Ono Pharmaceutical Co. Ltd
Chief Medical Officer since 2023
MD from an unspecified institution
Gyo Sagara
Ono Pharmaceutical Co. Ltd
Chief Executive Officer since 2024
PhD in Pharmaceutical Sciences from Kyoto University