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

Bristol-Myers Squibb33 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Esophageal Carcinoma Gastroesophageal Junction Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (24)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Disease-free Survival (DFS)

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

Secondary Outcomes

DFS in Subgroups of Interest

Time frame: 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

Overall Survival (OS)

Time frame: 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

Progression-free Survival (PFS)

Time frame: 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

Distant Metastasis-free Survival (DMFS)

Time frame: 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

Treatment Patterns of Adjuvant Nivolumab

Time frame: From baseline up to 42 months

Treatment Patterns of Subsequent Therapy

Data from ClinicalTrials.gov

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

San Luis Obispo, California, United States

Mission Cancer Center

Santa Maria, California, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

UPMC Hillman Cancer Center

Westwood, Kansas, United States

University Of Louisville

Louisville, Kentucky, United States

Weill Cornell Medical College

New York, New York, United States

Local Institution - 0009

Dallas, Texas, United States

William Beaumont Army Medical Center

Fort Bliss, Texas, United States

The University Of Texas

Houston, Texas, United States

...and 14 more locations

Time frame: 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

Time To Next Treatment

Time frame: 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

OS Rates for Participants That Received Subsequent Nivolumab Treatment

Time frame: 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

PFS Rates for Participants That Received Subsequent Nivolumab Treatment

Time frame: From baseline up to 42 months

Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment

Time frame: From baseline up to 42 months

Time to Disease Recurrence

Time frame: From baseline up to 42 months

Type of Disease Recurrence

Time frame: From baseline up to 42 months

Participant Sociodemographics

Time frame: From baseline up to 42 months

Number of Participants with Adverse Events

Time frame: 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

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

Time frame: 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 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

Time frame: 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)

Time frame: From baseline up to 42 months

Tumor histology at initial diagnosis

Squamous Cell Carcinoma (SSC) or adenocarcinoma

Time frame: From baseline up to 42 months

Pathologic lymph node status

ypN0, ypN1, ypN2, ypN3, unknown

Time frame: From baseline up to 42 months

Pathologic tumor status

ypT0, ypT1, ypT2, ypT3, ypT4, unknown

Time frame: 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

Time frame: From baseline up to 42 months

Type of recurrence

local/regional vs. distant

Time frame: From baseline up to 42 months

Serum levels of nuclear protein Ki67

Time frame: From baseline up to 42 months

Number of participants with metastasis

Time frame: From baseline up to 42 months

Sites of metastases

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

Time frame: From baseline up to 42 months

Comorbidities

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

Time frame: 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)

Time frame: From baseline up to 42 months

Concurrent medical conditions

Time frame: 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

Time frame: From baseline up to 42 months

Participant Treatment History

Time frame: From baseline up to 42 months