Phase 3
Completed N=970
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
Various Advanced Cancer
Source: ClinicalTrials.gov NCT03143153 ↗
Enrolled (actual)
970
Serious AEs
68.7%
Results posted
Mar 2022
Primary outcomePrimary: Overall Survival (OS) in Participants With Tumor Cell PD-L1 — 13.70; 15.44; 9.07 Months — p=0.0010
◆ Published Evidence
Highly cited
1,168citations · ~292 / year
Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma.
Summary
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
Linked Publications (3)
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Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma.
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First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50).
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Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in Participants With Tumor Cell PD-L1 |
13.70; 15.44; 9.07 | 0.0010 sig |
| PRIMARY Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1 |
4.04; 6.93; 4.44 | 0.8958 |
| SECONDARY Overall Survival (OS) in All Randomized Participants |
12.747; 13.207; 10.710 | — |
| SECONDARY Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR |
2.891; 5.782; 5.618 | — |
| SECONDARY Objective Response Rate (ORR) as Assessed by BICR |
20.1; 41.7; 33.7; 35.4; 53.2; 19.9 | — |
Eligibility Criteria
Inclusion Criteria
- Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
- Male or Female at least 18 years of age
- 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
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
Exclusion Criteria
- Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
- Active known or suspected autoimmune disease
- Any serious or uncontrolled medical disorder or active infection
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03143153) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.