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Esophageal CarcinomaPROSPECT-ESONCT05780736

A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer

An observational study of Esophageal Carcinoma and Gastroesophageal Junction Carcinoma, run by Bristol-Myers Squibb at 24 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
33 participants
Where
24 sitesin 2 countries
Study dates
4 Aug 2023to 23 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

Germany13 sites

  • Universitätsklinikum Bonn

    Bonn, Saarland, 53127

  • Klinikum Chemnitz Ggmbh

    Chemnitz, Saxony, 9113

  • BAG Freiberg-Richter, Jacobash, Illmer, Wolf

    Dresden, Saxony, 1307

  • Alexianer, Maria-Hilf-Krankenhaus

    Essen, North Rhine-Westphalia, 45136

  • Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde

    Hanover, Lower Saxony, 30169

  • Local Institution - 0033

    Homburg, Saarland, 66424

  • Klinikum Kassel

    Kassel, Hesse, 34125

  • Universitätsklinik Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • Local Institution - 0006

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum Munchen-Bogenhausen

    München, Bavaria, 81925

  • Oncologianova GmbH

    Recklinghausen, North Rhine-Westphalia, 45657

  • CaritasKlinikum Saarbruecken.

    Saarbrücken, Saarland, 66113

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

United States11 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233-1711

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706-1309

  • Local Institution - 0009

    Dallas, Texas, 75390-7208

  • William Beaumont Army Medical Center

    Fort Bliss, Texas, 79906-5327

  • The University Of Texas

    Houston, Texas, 77030-4000

  • University Of Louisville

    Louisville, Kentucky, 40202

  • Weill Cornell Medical College

    New York, New York, 10065-6007

  • Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center

    San Luis Obispo, California, 93401-7970

  • Mission Cancer Center

    Santa Maria, California, 93454-5909

  • Baylor Scott and White Health

    Temple, Texas, 76508-0001

  • UPMC Hillman Cancer Center

    Westwood, Kansas, 66205-2005

Other trials in United States

About this study

Official title: 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).

Keywords
Nivolumab, Adjuvant, Post Marketing, Non-interventional
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05780736
Study groupRoleWhat they receive
Cohort 1Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival (DFS)

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

Secondary outcomes (38)

  1. DFS in Subgroups of Interest

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

  2. DFS Rates in Subgroups of Interest

    Measured: From baseline up to 42 months

  3. Overall Survival (OS)

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

  4. OS Rates

    Measured: From baseline up to 42 months

  5. Progression-free Survival (PFS)

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

  6. PFS Rates

    Measured: From baseline up to 42 months

  7. Distant Metastasis-free Survival (DMFS)

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

  8. DMFS Rates

    Measured: From baseline up to 42 months

  9. Treatment Patterns of Adjuvant Nivolumab

    Measured: From baseline up to 42 months

  10. Treatment Patterns of Subsequent Therapy

    Measured: From baseline up to 42 months

  11. Post-recurrence Survival

    Measured: Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first

  12. Time To Next Treatment

    Measured: From baseline up to 42 months

  13. OS for Participants That Received Subsequent Nivolumab Treatment

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

  14. OS Rates for Participants That Received Subsequent Nivolumab Treatment

    Measured: From baseline up to 42 months

  15. PFS for Participants That Received Subsequent Nivolumab Treatment

    Measured: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first

  16. PFS Rates for Participants That Received Subsequent Nivolumab Treatment

    Measured: From baseline up to 42 months

  17. Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment

    Measured: From baseline up to 42 months

  18. Time to Disease Recurrence

    Measured: From baseline up to 42 months

  19. Type of Disease Recurrence

    Measured: From baseline up to 42 months

  20. Participant Sociodemographics

    Measured: From baseline up to 42 months

  21. Number of Participants with Adverse Events

    Measured: From baseline up to 42 months

  22. Number of Participants with Serious Adverse Events Related to Nivolumab Treatment

    Measured: From baseline up to 42 months

  23. 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

    Measured: From baseline up to 42 months

  24. Eastern Cooperative Oncology Group (ECOG) performance status

    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

    Measured: From baseline up to 42 months

  25. Tumor location at initial diagnosis

    EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available)

    Measured: From baseline up to 42 months

  26. Tumor histology at initial diagnosis

    Squamous Cell Carcinoma (SSC) or adenocarcinoma

    Measured: From baseline up to 42 months

  27. Pathologic lymph node status

    ypN0, ypN1, ypN2, ypN3, unknown

    Measured: From baseline up to 42 months

  28. Pathologic tumor status

    ypT0, ypT1, ypT2, ypT3, ypT4, unknown

    Measured: From baseline up to 42 months

  29. 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

    Measured: From baseline up to 42 months

  30. Type of recurrence

    local/regional vs. distant

    Measured: From baseline up to 42 months

  31. Serum levels of nuclear protein Ki67

    Measured: From baseline up to 42 months

  32. Number of participants with metastasis

    Measured: From baseline up to 42 months

  33. Sites of metastases

    Lung, brain, liver, peritoneum, bone, lymph nodes, other

    Measured: From baseline up to 42 months

  34. Comorbidities

    Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index.

    Measured: From baseline up to 42 months

  35. 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)

    Measured: From baseline up to 42 months

  36. Concurrent medical conditions

    Measured: From baseline up to 42 months

  37. 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

    Measured: From baseline up to 42 months

  38. Participant Treatment History

    Measured: From baseline up to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start4 Aug 2023
  3. Primary completion23 Aug 2024
  4. Study completion23 Aug 2024

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780736
Sponsor's protocol ID
CA209-6KX
Acronym
PROSPECT-ESO
Status last verified
Sep 2024
First submitted
24 Feb 2023
Last updated
25 Sep 2024
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Carcinoma and Gastroesophageal Junction Carcinoma, run by Bristol-Myers Squibb at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) (time frame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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