A Study to Evaluate Efficacy in Subjects with Esophageal Cancer Treatedwith Nivolumab and Ipilimumab or Nivolumab Combined with Fluorouracilplus Cisplatin versus Fluorouracil plus Cisplati

Phase 1

• Conditions: Inoperable advanced, recurrent or metastatic esophageal squamous cellcarcinoma (ESCC).; MedDRA version: 21.0Level: LLTClassification code 10055476Term: Esophageal squamous cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001514-20-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-18
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1127

Inclusion Criteria

- Must have histologically confirmed squamous cell carcinoma or
adenosquamous cell carcinoma of esophagus
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- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 451
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 676

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified