An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Phase 3

Active, not recruiting

• Conditions: Advanced Cancer
• Interventions: Other: Placebo; Drug: Nivolumab

• Registration Number: NCT02743494
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Study Start: 2016-07-14
• Primary Completion: 2020-05-12
• Results First Submitted: 2021-05-06
• Results First Submitted QC: 2021-05-28
• Results First Posted: 2021-06-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18
• Study Completion: 2025-10-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 794

Inclusion Criteria

• Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
• Completed pre-operative chemo radiotherapy followed by surgery
• Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion Criteria

• Diagnosed with cervical esophageal carcinoma
• Diagnosed with Stage IV resectable disease
• Did not receive concurrent chemoradiotherapy prior to surgery
• Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Other protocol defined Inclusion/exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Nivolumab	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	From randomization to the date of recurrence or death (up to approximately 46 months)	Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first.; Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From randomization to the date of death (up to approximately 46 months)	Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
Overall Survival Rate	From randomization to 1, 2 and 3 years later	Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization

Trial Locations

Locations (203)

Local Institution - 0250; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0026; 🇺🇸 Los Angeles, California, United States

Pacific Hematology Oncology Associates; 🇺🇸 San Francisco, California, United States

Local Institution - 0068; 🇺🇸 San Francisco, California, United States

Local Institution - 0151; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0247; 🇺🇸 Denver, Colorado, United States

Local Institution - 0054; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0113; 🇺🇸 Fort Myers, Florida, United States

Local Institution - 0131; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0226; 🇺🇸 Miami, Florida, United States

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