Immunotherapy + Chemotherapy for Esophageal Cancer
(CheckMate 648 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatment combinations to determine if they help people with esophageal cancer live longer or prevent cancer growth. It compares three groups: one receiving two immunotherapies (nivolumab and ipilimumab), another receiving the same immunotherapies plus chemotherapy (fluorouracil and cisplatin), and a group receiving traditional chemotherapy. People with esophageal cancer that cannot be surgically removed or treated with radiation, and who can still perform light activities, might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants access to potentially effective treatments.
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?
Research has shown that the combination of nivolumab and ipilimumab is generally well-tolerated. One study found that serious side effects occurred in 30% of patients who received these drugs with chemotherapy. However, this combination reduced the risk of disease progression or death by 38% compared to using nivolumab alone.
Studies have demonstrated that the combination of nivolumab with cisplatin and fluorouracil helps patients with advanced esophageal cancer live longer. This combination has received FDA approval for similar conditions, indicating its safety.
While both treatments carry risks of side effects, extensive studies have shown promising results in terms of safety and effectiveness.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine traditional chemotherapy with cutting-edge immunotherapy. Unlike standard treatments for esophageal cancer that typically rely on chemotherapy alone, like Cisplatin and Fluorouracil, the addition of immunotherapy drugs such as Nivolumab and Ipilimumab offers a new approach by harnessing the immune system to fight the cancer. This immunotherapy works by blocking proteins that prevent the immune system from attacking cancer cells, potentially leading to more effective and targeted treatment. This innovative approach could improve outcomes for patients by enhancing the body's natural defenses against cancer.
What evidence suggests that this trial's treatments could be effective for esophageal cancer?
Research has shown that using nivolumab and ipilimumab together may help treat esophageal cancer. In clinical trials, patients receiving this combination had a 38% lower risk of disease progression or death compared to those taking nivolumab alone. Another study found that this combination also provided better overall survival benefits than chemotherapy alone. One arm of this trial will study the combination of nivolumab and ipilimumab.
Another arm will study the combination of nivolumab with the chemotherapy drugs cisplatin and fluorouracil. Studies have shown this combination offers a significant survival advantage for patients with advanced esophageal cancer, with higher response rates than other treatments. Both treatment options are under investigation in this trial for their potential to improve outcomes in esophageal cancer.35678Who 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 adults with esophageal cancer that's inoperable, recurrent, or metastatic. Participants must be able to perform light activities and provide a tumor tissue sample. It excludes those with symptomatic brain/spinal tumors, serious medical conditions, active infections, HIV/AIDS, hepatitis B/C infection, or autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nivolumab plus ipilimumab, nivolumab combined with fluorouracil plus cisplatin, or fluorouracil plus cisplatin
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Fluorouracil
- Ipilimumab
- Nivolumab
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
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