A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer
Megadott ok: A decision was made to terminate the study due to expected timelines associated with start-up, participant enrollment, ethics committee approval and data availability from the study.
Key facts
- Where
- Bonn, Chemnitz, Dresden, Essen, Hanover, Homburg, Kassel, Magdeburg, Mainz, München, Recklinghausen, Saarbrücken és Tübingen, NémetországSee the 13 sites
Where in Németország
- Universitätsklinikum BonnBonn, NémetországNo longer taking part
- Klinikum Chemnitz gGmbHChemnitz, NémetországNo longer taking part
- BAG Freiberg-Richter, Jacobash, Illmer, WolfDresden, NémetországNo longer taking part
- Alexianer, Maria-Hilf-KrankenhausEssen, NémetországNo longer taking part
- Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der HeydeHanover, NémetországNo longer taking part
- HomburgHomburg, NémetországNo longer taking part
- Klinikum KasselKassel, NémetországNo longer taking part
- Universitätsklinik MagdeburgMagdeburg, NémetországNo longer taking part
- MainzMainz, NémetországNo longer taking part
- Klinikum München-BogenhausenMünchen, NémetországNo longer taking part
- Oncologianova GmbHRecklinghausen, NémetországNo longer taking part
- CaritasKlinikum Saarbruecken.Saarbrücken, NémetországNo longer taking part
- Universitätsklinikum TübingenTübingen, NémetországNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05780736
- Record updated
- 2024. szeptember 25.
- Original description
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).Read full original descriptionShow less
Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study
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).
Inclusion: 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.
Exclusion: 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).