Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT02569242
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
  • Docetaxel/Paclitaxel — DRUG

Study Details

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.

Key Dates

Start date
Dec 14, 2015
Status verified
Jan 2022
Primary completion
Oct 23, 2020
Completion
Oct 23, 2020

Study Design

Enrollment
419 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Overall Survival [ Time Frame: ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Georgetown University Med CtrWashington D.C.District of Columbia20007-
Orlando Health, IncOrlandoFlorida32806-
Massachusetts General HospitalBostonMassachusetts02114-
Duke Cancer InstituteDurhamNorth Carolina27710-
Vanderbilt-Ingram Cancer CtrNashvilleTennessee37232-
The University Of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Gilbert, AZ

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Banner MD Anderson Cancer Center· Gilbert, AZGeorgetown University Med Ctr· Washington D.C., DCOrlando Health, Inc· Orlando, FLMassachusetts General Hospital· Boston, MADuke Cancer Institute· Durham, NCVanderbilt-Ingram Cancer Ctr· Nashville, TN

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