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

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).

Study Overview

• Status: Terminated
• Conditions: Esophageal Carcinoma; Gastroesophageal Junction Carcinoma

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Universitatsklinikum Tubingen
  • Bayern
    • Munchen, Bayern, Germany, 81925
      • Klinikum München-Bogenhausen
  • Hessen
    • Kassel, Hessen, Germany, 34125
      • Klinikum Kassel
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30169
      • Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • Alexianer, Maria-Hilf-Krankenhaus
    • Recklinghausen, Nordrhein-Westfalen, Germany, 45657
      • Oncologianova GmbH
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Local Institution - 0006
  • Saarland
    • Bonn, Saarland, Germany, 53127
      • Universitatsklinikum Bonn
    • Homburg, Saarland, Germany, 66424
      • Local Institution - 0033
    • Saarbruecken, Saarland, Germany, 66113
      • CaritasKlinikum Saarbruecken.
  • Sachsen
    • Chemnitz, Sachsen, Germany, 9113
      • Klinikum Chemnitz gGmbH
    • Dresden, Sachsen, Germany, 1307
      • BAG Freiberg-Richter, Jacobash, Illmer, Wolf
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Universitätsklinik Magdeburg
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1711
      • University of Alabama at Birmingham
  • California
    • San Luis Obispo, California, United States, 93401-7970
      • Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
    • Santa Maria, California, United States, 93454-5909
      • Mission Cancer Center
  • Idaho
    • Boise, Idaho, United States, 83706-1309
      • Saint Alphonsus Regional Medical Center
  • Kansas
    • Westwood, Kansas, United States, 66205-2005
      • UPMC Hillman Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • New York, New York, United States, 10065-6007
      • Weill Cornell Medical College
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • Local Institution - 0009
    • Fort Bliss, Texas, United States, 79906-5327
      • William Beaumont Army Medical Center
    • Houston, Texas, United States, 77030-4000
      • The University of Texas
    • Temple, Texas, United States, 76508-0001
      • Baylor Scott and White Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free Survival (DFS)	Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PFS 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
DMFS Rates		From baseline up to 42 months
Treatment Patterns of Adjuvant Nivolumab		From baseline up to 42 months
Treatment Patterns of Subsequent Therapy		From baseline up to 42 months
Post-recurrence Survival		Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first
Time To Next Treatment		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
OS Rates for Participants That Received Subsequent Nivolumab Treatment		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
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
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
Number of Participants with Adverse Events		From baseline up to 42 months
Number of Participants with Serious Adverse Events Related to Nivolumab Treatment		From baseline up to 42 months
Disease stage at initial diagnosis	Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) stage (i.e., I, II or III) and stage using Tumor, node, and metastasis (TNM) system	From baseline up to 42 months
Eastern Cooperative Oncology Group (ECOG) performance status	0: Fully active, able to carry on all pre-disease performance without restriction; Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature; Ambulatory and capable of all self-care but unable to carry out work activities. Up and about more than 50% of waking hours; Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Dead	From baseline up to 42 months
Tumor location at initial diagnosis	EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available)	From baseline up to 42 months
Tumor histology at initial diagnosis	Squamous Cell Carcinoma (SSC) or adenocarcinoma	From baseline up to 42 months
Pathologic lymph node status	ypN0, ypN1, ypN2, ypN3, unknown	From baseline up to 42 months
Pathologic tumor status	ypT0, ypT1, ypT2, ypT3, ypT4, unknown	From baseline up to 42 months
Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable)	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	From baseline up to 42 months
Type of recurrence	local/regional vs. distant	From baseline up to 42 months
Serum levels of nuclear protein Ki67		From baseline up to 42 months
Number of participants with metastasis		From baseline up to 42 months
Sites of metastases	Lung, brain, liver, peritoneum, bone, lymph nodes, other	From baseline up to 42 months
Comorbidities	Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index.	From baseline up to 42 months
Concomitant treatments	Type of treatment or therapies receive in parallel of nivolumab treatment and details (e.g., medications, radiotherapy, chemotherapy, systemic therapy, or surgical treatment)	From baseline up to 42 months
Concurrent medical conditions		From baseline up to 42 months
Prior treatments for EC/GEJC	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	From baseline up to 42 months
Participant Treatment History		From baseline up to 42 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: PPD Development, LP
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): August 23, 2024
• Study Completion (Actual): August 23, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Nivolumab; Adjuvant; Non-interventional; Post Marketing
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: CA209-6KX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO