A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer (PROSPECT-ESO)

September 24, 2024 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort 1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Disease-free Survival (DFS)
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DFS in Subgroups of Interest
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
DFS Rates in Subgroups of Interest
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Overall Survival (OS)
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
OS Rates
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Progression-free Survival (PFS)
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
PFS Rates
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Distant Metastasis-free Survival (DMFS)
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
DMFS Rates
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Treatment Patterns of Adjuvant Nivolumab
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Treatment Patterns of Subsequent Therapy
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Post-recurrence Survival
Time Frame: Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first
Time To Next Treatment
Time Frame: From baseline up to 42 months
From baseline up to 42 months
OS for Participants That Received Subsequent Nivolumab Treatment
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
OS Rates for Participants That Received Subsequent Nivolumab Treatment
Time Frame: From baseline up to 42 months
From baseline up to 42 months
PFS for Participants That Received Subsequent Nivolumab Treatment
Time Frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
PFS Rates for Participants That Received Subsequent Nivolumab Treatment
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Time to Disease Recurrence
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Type of Disease Recurrence
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Participant Sociodemographics
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Number of Participants with Adverse Events
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Number of Participants with Serious Adverse Events Related to Nivolumab Treatment
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Disease stage at initial diagnosis
Time Frame: 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
From baseline up to 42 months
Eastern Cooperative Oncology Group (ECOG) performance status
Time Frame: 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. Dead
From baseline up to 42 months
Tumor location at initial diagnosis
Time Frame: From baseline up to 42 months
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
Time Frame: From baseline up to 42 months
Squamous Cell Carcinoma (SSC) or adenocarcinoma
From baseline up to 42 months
Pathologic lymph node status
Time Frame: From baseline up to 42 months
ypN0, ypN1, ypN2, ypN3, unknown
From baseline up to 42 months
Pathologic tumor status
Time Frame: From baseline up to 42 months
ypT0, ypT1, ypT2, ypT3, ypT4, unknown
From baseline up to 42 months
Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable)
Time Frame: 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
From baseline up to 42 months
Type of recurrence
Time Frame: From baseline up to 42 months
local/regional vs. distant
From baseline up to 42 months
Serum levels of nuclear protein Ki67
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Number of participants with metastasis
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Sites of metastases
Time Frame: From baseline up to 42 months
Lung, brain, liver, peritoneum, bone, lymph nodes, other
From baseline up to 42 months
Comorbidities
Time Frame: From baseline up to 42 months
Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index.
From baseline up to 42 months
Concomitant treatments
Time Frame: 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)
From baseline up to 42 months
Concurrent medical conditions
Time Frame: From baseline up to 42 months
From baseline up to 42 months
Prior treatments for EC/GEJC
Time Frame: 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
From baseline up to 42 months
Participant Treatment History
Time Frame: From baseline up to 42 months
From baseline up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PPD Development, LP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-6KX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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