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 Cisplati

Phase 1

• Conditions: Inoperable advanced, recurrent or metastatic esophageal squamous cell carcinoma (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-PL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Last Update Posted: 30 January 2023

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
- 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