Clinical trial NCT05780736: A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer
Official title: Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophageal Carcinoma
Gastroesophageal Junction Carcinoma
Keywords: Nivolumab
Adjuvant
Post Marketing
Non-interventional
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2023-03-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary outcomes:
measure: DFS in Subgroups of Interest
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: DFS Rates in Subgroups of Interest
timeFrame: From baseline up to 42 months
measure: Overall Survival (OS)
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: OS Rates
timeFrame: From baseline up to 42 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: PFS Rates
timeFrame: From baseline up to 42 months
measure: Distant Metastasis-free Survival (DMFS)
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: DMFS Rates
timeFrame: From baseline up to 42 months
measure: Treatment Patterns of Adjuvant Nivolumab
timeFrame: From baseline up to 42 months
measure: Treatment Patterns of Subsequent Therapy
timeFrame: From baseline up to 42 months
measure: Post-recurrence Survival
timeFrame: Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: Time To Next Treatment
timeFrame: From baseline up to 42 months
measure: OS for Participants That Received Subsequent Nivolumab Treatment
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: OS Rates for Participants That Received Subsequent Nivolumab Treatment
timeFrame: From baseline up to 42 months
measure: PFS for Participants That Received Subsequent Nivolumab Treatment
timeFrame: Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
measure: PFS Rates for Participants That Received Subsequent Nivolumab Treatment
timeFrame: From baseline up to 42 months
measure: Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment
timeFrame: From baseline up to 42 months
measure: Time to Disease Recurrence
timeFrame: From baseline up to 42 months
measure: Type of Disease Recurrence
timeFrame: From baseline up to 42 months
measure: Participant Sociodemographics
timeFrame: From baseline up to 42 months
measure: Number of Participants with Adverse Events
timeFrame: From baseline up to 42 months
measure: Number of Participants with Serious Adverse Events Related to Nivolumab Treatment
timeFrame: From baseline up to 42 months
measure: Disease stage at initial diagnosis
timeFrame: From baseline up to 42 months
measure: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: From baseline up to 42 months
measure: Tumor location at initial diagnosis
timeFrame: From baseline up to 42 months
measure: Tumor histology at initial diagnosis
timeFrame: From baseline up to 42 months
measure: Pathologic lymph node status
timeFrame: From baseline up to 42 months
measure: Pathologic tumor status
timeFrame: From baseline up to 42 months
measure: Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable)
timeFrame: From baseline up to 42 months
measure: Type of recurrence
timeFrame: From baseline up to 42 months
measure: Serum levels of nuclear protein Ki67
timeFrame: From baseline up to 42 months
measure: Number of participants with metastasis
timeFrame: From baseline up to 42 months
measure: Sites of metastases
timeFrame: From baseline up to 42 months
measure: Comorbidities
timeFrame: From baseline up to 42 months
measure: Concomitant treatments
timeFrame: From baseline up to 42 months
measure: Concurrent medical conditions
timeFrame: From baseline up to 42 months
measure: Prior treatments for EC/GEJC
timeFrame: From baseline up to 42 months
measure: Participant Treatment History
timeFrame: From baseline up to 42 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Luis Obispo
country: United States
facility: Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
state: California
city: Santa Maria
country: United States
facility: Mission Cancer Center
state: California
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Westwood
country: United States
facility: UPMC Hillman Cancer Center
state: Kansas
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Dallas
country: United States
facility: Local Institution - 0009
state: Texas
city: Fort Bliss
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Houston
country: United States
facility: The University Of Texas
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Health
state: Texas
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Munchen
country: Germany
facility: Klinikum Munchen-Bogenhausen
state: Bayern
city: Kassel
country: Germany
facility: Klinikum Kassel
state: Hessen
city: Hannover
country: Germany
facility: Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde
state: Niedersachsen
city: Essen
country: Germany
facility: Alexianer, Maria-Hilf-Krankenhaus
state: Nordrhein-Westfalen
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Local Institution - 0006
state: Rheinland-Pfalz
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Saarland
city: Homburg
country: Germany
facility: Local Institution - 0033
state: Saarland
city: Saarbruecken
country: Germany
facility: CaritasKlinikum Saarbruecken.
state: Saarland
city: Magdeburg
country: Germany
facility: Universitätsklinik Magdeburg
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz Ggmbh
state: Sachsen
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobash, Illmer, Wolf
state: Sachsen
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: