A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer
- Conditions
- Esophageal CarcinomaGastroesophageal Junction Carcinoma
- Registration Number
- NCT05780736
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 314
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free Survival (DFS) Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
- Secondary Outcome Measures
Name Time Method Time To Next Treatment From baseline up to 42 months Serum levels of nuclear protein Ki67 From baseline up to 42 months DFS in Subgroups of Interest Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first Post-recurrence Survival Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first OS Rates From baseline up to 42 months PFS Rates From baseline up to 42 months PFS for Participants That Received Subsequent Nivolumab Treatment Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first Time to Disease Recurrence From baseline up to 42 months Type of Disease Recurrence From baseline up to 42 months Participant Sociodemographics From baseline up to 42 months Eastern Cooperative Oncology Group (ECOG) performance status From baseline up to 42 months 0: Fully active, able to carry on all pre-disease performance without restriction
1. Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature
2. Ambulatory and capable of all self-care but unable to carry out work activities. Up and about more than 50% of waking hours
3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5. DeadComorbidities From baseline up to 42 months Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index.
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 Progression-free Survival (PFS) Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first Treatment Patterns of Adjuvant Nivolumab From baseline up to 42 months Treatment Patterns of Subsequent Therapy From baseline up to 42 months Number of participants with metastasis From baseline up to 42 months Concomitant treatments From baseline up to 42 months Type of treatment or therapies receive in parallel of nivolumab treatment and details (e.g., medications, radiotherapy, chemotherapy, systemic therapy, or surgical treatment)
Prior treatments for EC/GEJC From baseline up to 42 months Type of therapies received prior to initiation of nivolumab treatment (e.g., radiotherapy, chemotherapy, targeted therapy, systemic treatment, platinum-based therapy) and details (if applicable, e.g., regimens, dosing
DMFS Rates From baseline up to 42 months Distant Metastasis-free Survival (DMFS) Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first OS Rates for Participants That Received Subsequent Nivolumab Treatment From baseline up to 42 months Disease stage at initial diagnosis From baseline up to 42 months Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) stage (i.e., I, II or III) and stage using Tumor, node, and metastasis (TNM) system
Tumor location at initial diagnosis From baseline up to 42 months EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available)
Tumor histology at initial diagnosis From baseline up to 42 months Squamous Cell Carcinoma (SSC) or adenocarcinoma
Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable) From baseline up to 42 months Tumor cell PD-L1 expression levels and cells assessed. This will be used to group PD-L1 expression into ≥1%, \<1%, or Indeterminate/non-evaluable and to derive the combined positive score (CPS) score which is defined as PD-L1 positive tumor cells + PD-L1 positive mononuclear inflammatory cells)/Total tumor cells) × 100
Number of Participants with Serious Adverse Events Related to Nivolumab Treatment From baseline up to 42 months Sites of metastases From baseline up to 42 months Lung, brain, liver, peritoneum, bone, lymph nodes, other
Concurrent medical conditions From baseline up to 42 months OS for Participants That Received Subsequent Nivolumab Treatment Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first PFS Rates for Participants That Received Subsequent Nivolumab Treatment From baseline up to 42 months Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment From baseline up to 42 months Number of Participants with Adverse Events From baseline up to 42 months Pathologic lymph node status From baseline up to 42 months ypN0, ypN1, ypN2, ypN3, unknown
Pathologic tumor status From baseline up to 42 months ypT0, ypT1, ypT2, ypT3, ypT4, unknown
Type of recurrence From baseline up to 42 months local/regional vs. distant
Participant Treatment History From baseline up to 42 months
Trial Locations
- Locations (24)
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-Württemberg, Germany
Klinikum Munchen-Bogenhausen
🇩🇪Munchen, Bayern, Germany
Klinikum Kassel
🇩🇪Kassel, Hessen, Germany
Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde
🇩🇪Hannover, Niedersachsen, Germany
Alexianer, Maria-Hilf-Krankenhaus
🇩🇪Essen, Nordrhein-Westfalen, Germany
Oncologianova GmbH
🇩🇪Recklinghausen, Nordrhein-Westfalen, Germany
Local Institution - 0006
🇩🇪Mainz, Rheinland-Pfalz, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Saarland, Germany
Local Institution - 0033
🇩🇪Homburg, Saarland, Germany
CaritasKlinikum Saarbruecken.
🇩🇪Saarbruecken, Saarland, Germany
Universitätsklinik Magdeburg
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Klinikum Chemnitz Ggmbh
🇩🇪Chemnitz, Sachsen, Germany
BAG Freiberg-Richter, Jacobash, Illmer, Wolf
🇩🇪Dresden, Sachsen, Germany