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

Stopped early

Conditions studied: Esophageal Carcinoma, Gastroesophageal Junction Carcinoma

In brief

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).

Key facts

Study ID

NCT05780736

Run by

Bristol-Myers Squibb

People needed

33

Starts

2023-08-04

Expected to finish

2024-08-23

Last updated by the study team

2024-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must provide voluntary informed consent to participate in the study before inclusion in the study
• Must have confirmed diagnosis of resected early stage (Stage II/III) EC or GEJC (histologically or cytologically confirmed stage)
• 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

You may not qualify if…

• 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.)
• Prior treatment with immuno-oncologic agents, including nivolumab, for any indication
• 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)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center — San Luis Obispo, California, United States
• Mission Cancer Center — Santa Maria, California, United States
• Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• UPMC Hillman Cancer Center — Westwood, Kansas, United States
• University Of Louisville — Louisville, Kentucky, United States
• Weill Cornell Medical College — New York, New York, United States
• Local Institution - 0009 — Dallas, Texas, United States
• William Beaumont Army Medical Center — Fort Bliss, Texas, United States
• The University Of Texas — Houston, Texas, United States
• Baylor Scott and White Health — Temple, Texas, United States
• Universitätsklinikum Tübingen — Tübingen, Baden-Wurttemberg, Germany
• Klinikum Munchen-Bogenhausen — München, Bavaria, Germany
• Klinikum Kassel — Kassel, Hesse, Germany
• Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde — Hanover, Lower Saxony, Germany
• Alexianer, Maria-Hilf-Krankenhaus — Essen, North Rhine-Westphalia, Germany
• Oncologianova GmbH — Recklinghausen, North Rhine-Westphalia, Germany
• Local Institution - 0006 — Mainz, Rhineland-Palatinate, Germany
• Universitätsklinikum Bonn — Bonn, Saarland, Germany
• Local Institution - 0033 — Homburg, Saarland, Germany
• CaritasKlinikum Saarbruecken. — Saarbrücken, Saarland, Germany
• Klinikum Chemnitz Ggmbh — Chemnitz, Saxony, Germany
• BAG Freiberg-Richter, Jacobash, Illmer, Wolf — Dresden, Saxony, Germany
• Universitätsklinik Magdeburg — Magdeburg, Saxony-Anhalt, Germany

Full record on ClinicalTrials.gov

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