A phase III study of Nivolumab (CheckMate648)(ONO-4538-50/CA209648)

ONO-4538-50/CA209648:A randomized phase 3 study of Nivolumab plus Ipilimumab or Nivolumab combined with Fluorouracil plus Cisplatin versus Fluorouracil plus Cisplatin in subjects with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223543

Enrollment

939

Registered

2017-05-30

Start date

2017-06-29

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

investigational material(s) Generic name etc : Nivolumab, Ipilimumab, Fluorouracil, Cisplatin INN of investigational material : Nivolumab, Ipilimumab, Fluorouracil, Cisplatin Therapeutic category code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus. 2. Must have esophageal cancer that cannot be operated on, or treated with definitive. chemoradiation with curative intent, that is advanced, reoccurring or has spread out. 3. ECOG PS 0 or 1. 4. Must agree to provide tumor tissue sample.

Exclusion criteria

Exclusion criteria: 1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment. 2. Active known or suspected autoimmune disease. 3. Any serious or uncontrolled medical disorder or active infection. 4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 5. Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.

Design outcomes

Primary

Measure	Time frame
efficacy Overall survival (OS), Progression free Survival (PFS) in subjects with PD-L1 expressing tumors	—

Secondary

Measure	Time frame
safety efficacy other 1. OS , PFS in all randomized subjects 2. Objective Response Rate (ORR) in subjects with PD-L1 expressing tumors and All Randomized subjects	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactSupport Desk JP

ONO PHARMACEUTICAL CO.,LTD.

clinical_trial@ono.co.jp+81-120278120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026