Study Stopped
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.
A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer
PROSPECT-ESO
Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study
1 other identifier
observational
33
2 countries
24
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedStudy Start
First participant enrolled
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2024
CompletedSeptember 25, 2024
September 1, 2024
1.1 years
February 24, 2023
September 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival (DFS)
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary Outcomes (38)
DFS in Subgroups of Interest
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
DFS Rates in Subgroups of Interest
From baseline up to 42 months
Overall Survival (OS)
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
OS Rates
From baseline up to 42 months
Progression-free Survival (PFS)
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
- +33 more secondary outcomes
Study Arms (1)
Cohort 1
Eligibility Criteria
The study population will consist of participants from the United States and Germany with early stage (Stage II/III) EC/GEJC who received adjuvant nivolumab after resection.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- PPD Development, LPcollaborator
Study Sites (24)
University of Alabama at Birmingham
Birmingham, Alabama, 35233-1711, United States
Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
San Luis Obispo, California, 93401-7970, United States
Mission Cancer Center
Santa Maria, California, 93454-5909, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706-1309, United States
UPMC Hillman Cancer Center
Westwood, Kansas, 66205-2005, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Weill Cornell Medical College
New York, New York, 10065-6007, United States
Local Institution - 0009
Dallas, Texas, 75390-7208, United States
William Beaumont Army Medical Center
Fort Bliss, Texas, 79906-5327, United States
The University Of Texas
Houston, Texas, 77030-4000, United States
Baylor Scott and White Health
Temple, Texas, 76508-0001, United States
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Klinikum Munchen-Bogenhausen
München, Bavaria, 81925, Germany
Klinikum Kassel
Kassel, Hesse, 34125, Germany
Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde
Hanover, Lower Saxony, 30169, Germany
Alexianer, Maria-Hilf-Krankenhaus
Essen, North Rhine-Westphalia, 45136, Germany
Oncologianova GmbH
Recklinghausen, North Rhine-Westphalia, 45657, Germany
Local Institution - 0006
Mainz, Rhineland-Palatinate, 55131, Germany
Universitätsklinikum Bonn
Bonn, Saarland, 53127, Germany
Local Institution - 0033
Homburg, Saarland, 66424, Germany
CaritasKlinikum Saarbruecken.
Saarbrücken, Saarland, 66113, Germany
Klinikum Chemnitz Ggmbh
Chemnitz, Saxony, 9113, Germany
BAG Freiberg-Richter, Jacobash, Illmer, Wolf
Dresden, Saxony, 1307, Germany
Universitätsklinik Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2023
First Posted
March 23, 2023
Study Start
August 4, 2023
Primary Completion
August 23, 2024
Study Completion
August 23, 2024
Last Updated
September 25, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share