Immunotherapy + Chemotherapy for Esophageal Cancer

(CheckMate 648 Trial)

Recruiting at 362 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Autoimmune disease, HIV/AIDS, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

970 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

I can walk and do light activities like housework or office work.

My cancer is a type of esophageal cancer called squamous cell or adenosquamous carcinoma.

My esophageal cancer is advanced, cannot be surgically removed, or treated with the intent to cure.

Exclusion Criteria

I have tested positive for hepatitis B or C.

I have cancer in my brain or spinal cord that shows symptoms or needs treatment.

I have tested positive for HIV/AIDS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nivolumab plus ipilimumab, nivolumab combined with fluorouracil plus cisplatin, or fluorouracil plus cisplatin

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 months

Treatment Details

Interventions

• Cisplatin
• Fluorouracil
• Ipilimumab
• Nivolumab

Trial Overview The study compares the effectiveness of Nivolumab plus Ipilimumab or combined with Fluorouracil and Cisplatin against just Fluorouracil plus Cisplatin in extending life without disease progression in esophageal cancer patients.

Participant Groups

Group I: Nivolumab + Ipilimumab Experimental Treatment 2 Interventions

Group II: Nivolumab + Cisplatin + Fluorouacil Experimental Treatment 3 Interventions

Group III: Cisplatin + Fluorouracil Active Control 2 Interventions

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Trials

182

Recruited

97,100+

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