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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05780736

Collaborator

PPD (Industry)

314

Enrollment

Locations

65.5

Anticipated Duration (Months)

104.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Esophageal Carcinoma Gastroesophageal Junction Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

314 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Sep 30, 2028

Anticipated Study Completion Date :

Sep 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1

Outcome Measures

Primary Outcome Measures

Disease-free Survival (DFS) [Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first]

Secondary Outcome Measures

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 [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
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 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
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
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
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
Type of recurrence [From baseline up to 42 months]
local/regional vs. distant
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 [From baseline up to 42 months]
Lung, brain, liver, peritoneum, bone, lymph nodes, other
Comorbidities [From baseline up to 42 months]
Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index.
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)
Concurrent medical conditions [From baseline up to 42 months]
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
Participant Treatment History [From baseline up to 42 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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

Exclusion criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Louisville	Louisville	Kentucky	United States	40202
2	William Beaumont Army Medical Center	Fort Bliss	Texas	United States	79906-5327
3	The University Of Texas	Houston	Texas	United States	77030-4000