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Trial record 1 of 1 for:    NCT02569242
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Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02569242
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Nivolumab Drug: Docetaxel/Paclitaxel Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ONO-4538 Phase III Study A Multicenter, Randomized, Open-label Study in Patients With Unresectable Advanced or Recurrent Esophageal Cancer
Study Start Date : December 2015
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nivolumab Arm
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Nivolumab
Active Comparator: Active Comparator Arm (Docetaxel/Paclitaxel)

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Drug: Docetaxel/Paclitaxel


Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Estimated time frame: 30 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Estimated time frame: 30 months ]
  2. Objective response rate [ Time Frame: Estimated time frame: 30 months ]
  3. Duration of response [ Time Frame: Estimated time frame: 30 months ]
  4. Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]
  5. Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men & women ≥20 years of age
  • Histologically confirmed unresectable advanced or recurrent esophageal cancer
  • Refractory to or intolerant of standard therapy
  • ECOG Performance Status score 0 or 1
  • A life expectancy of at least 3 months

Exclusion Criteria:

  • Current or past history of severe hypersensitivity to any other antibody products
  • Patients with multiple primary cancers
  • Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
  • Patients with active, known or suspected autoimmune disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569242


  Show 89 Study Locations
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Investigators
Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd
More Information

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT02569242     History of Changes
Other Study ID Numbers: ONO-4538-24/CA209-473
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Docetaxel
Nivolumab
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs