A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer

NCT ID: NCT05780736

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-04

Study Completion Date

2024-08-23

Brief Summary

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The purpose of this study is to describe the effectiveness and use of nivolumab after surgery in participants with early stage (Stage II/III) Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC).

Detailed Description

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Conditions

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Esophageal Carcinoma Gastroesophageal Junction Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Must provide voluntary informed consent to participate in the study before inclusion in the study
2. Must have confirmed diagnosis of resected early stage (Stage II/III) EC or GEJC (histologically or cytologically confirmed stage)
3. Physician decision to treat the participant with adjuvant nivolumab (according to the local label as per country-specific regulations) must be made prior to and independently of participation in the study

Exclusion Criteria

1. Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days (Participants who have completed their participation in an interventional trial and who are only followed-up for OS can be enrolled.)
2. Prior treatment with immuno-oncologic agents, including nivolumab, for any indication
3. Participants with a current primary diagnosis of a cancer other than EC or GEJC that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center

San Luis Obispo, California, United States

Site Status

Mission Cancer Center

Santa Maria, California, United States

Site Status

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

UPMC Hillman Cancer Center

Westwood, Kansas, United States

Site Status

University Of Louisville

Louisville, Kentucky, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Local Institution - 0009

Dallas, Texas, United States

Site Status

William Beaumont Army Medical Center

Fort Bliss, Texas, United States

Site Status

The University Of Texas

Houston, Texas, United States

Site Status

Baylor Scott and White Health

Temple, Texas, United States

Site Status

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Klinikum Munchen-Bogenhausen

München, Bavaria, Germany

Site Status

Klinikum Kassel

Kassel, Hesse, Germany

Site Status

Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde

Hanover, Lower Saxony, Germany

Site Status

Alexianer, Maria-Hilf-Krankenhaus

Essen, North Rhine-Westphalia, Germany

Site Status

Oncologianova GmbH

Recklinghausen, North Rhine-Westphalia, Germany

Site Status

Local Institution - 0006

Mainz, Rhineland-Palatinate, Germany

Site Status

Universitätsklinikum Bonn

Bonn, Saarland, Germany

Site Status

Local Institution - 0033

Homburg, Saarland, Germany

Site Status

CaritasKlinikum Saarbruecken.

Saarbrücken, Saarland, Germany

Site Status

Klinikum Chemnitz Ggmbh

Chemnitz, Saxony, Germany

Site Status

BAG Freiberg-Richter, Jacobash, Illmer, Wolf

Dresden, Saxony, Germany

Site Status

Universitätsklinik Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status

Countries

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United States Germany

Related Links

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Other Identifiers

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CA209-6KX

Identifier Type: -

Identifier Source: org_study_id

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