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

Esophageal Carcinoma Clinical Trial

— PROSPECT-ESO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780736
• Other study ID #: CA209-6KX
• Status: Recruiting
• Start date: August 4, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms
• Gastroesophageal Junction Carcinoma

Locations

Country	Name	City	State
Germany	Local Institution - 0032	Bonn	Saarland
Germany	Klinikum Chemnitz Ggmbh	Chemnitz	Sachsen
Germany	BAG Freiberg-Richter, Jacobash, Illmer, Wolf	Dresden	Sachsen
Germany	Alexianer, Maria-Hilf-Krankenhaus	Essen	Nordrhein-Westfalen
Germany	Klinikum Kassel	Kassel	Hessen
Germany	Local Institution - 0006	Mainz	Rheinland-Pfalz
Germany	Local Institution - 0022	Offenbach	Hessen
Germany	Oncologianova GmbH	Recklinghausen	Nordrhein-Westfalen
Germany	CaritasKlinikum Saarbruecken.	Saarbruecken	Saarland
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
United States	William Beaumont Army Medical Center	Fort Bliss	Texas
United States	The University Of Texas	Houston	Texas
United States	University Of Louisville	Louisville	Kentucky
United States	Baylor Scott and White Health	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	PPD

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival (DFS)		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	DFS in Subgroups of Interest		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	DFS Rates in Subgroups of Interest		From baseline up to 42 months
Secondary	Overall Survival (OS)		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	OS Rates		From baseline up to 42 months
Secondary	Progression-free Survival (PFS)		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	PFS Rates		From baseline up to 42 months
Secondary	Distant Metastasis-free Survival (DMFS)		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	DMFS Rates		From baseline up to 42 months
Secondary	Treatment Patterns of Adjuvant Nivolumab		From baseline up to 42 months
Secondary	Treatment Patterns of Subsequent Therapy		From baseline up to 42 months
Secondary	Post-recurrence Survival		Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	Time To Next Treatment		From baseline up to 42 months
Secondary	OS for Participants That Received Subsequent Nivolumab Treatment		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	OS Rates for Participants That Received Subsequent Nivolumab Treatment		From baseline up to 42 months
Secondary	PFS for Participants That Received Subsequent Nivolumab Treatment		Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first
Secondary	PFS Rates for Participants That Received Subsequent Nivolumab Treatment		From baseline up to 42 months
Secondary	Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment		From baseline up to 42 months
Secondary	Time to Disease Recurrence		From baseline up to 42 months
Secondary	Type of Disease Recurrence		From baseline up to 42 months
Secondary	Participant Sociodemographics		From baseline up to 42 months
Secondary	Number of Participants with Adverse Events		From baseline up to 42 months
Secondary	Number of Participants with Serious Adverse Events Related to Nivolumab Treatment		From baseline up to 42 months
Secondary	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	From baseline up to 42 months
Secondary	Eastern Cooperative Oncology Group (ECOG) performance status	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	From baseline up to 42 months
Secondary	Tumor location at initial diagnosis	EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available)	From baseline up to 42 months
Secondary	Tumor histology at initial diagnosis	Squamous Cell Carcinoma (SSC) or adenocarcinoma	From baseline up to 42 months
Secondary	Pathologic lymph node status	ypN0, ypN1, ypN2, ypN3, unknown	From baseline up to 42 months
Secondary	Pathologic tumor status	ypT0, ypT1, ypT2, ypT3, ypT4, unknown	From baseline up to 42 months
Secondary	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	From baseline up to 42 months
Secondary	Type of recurrence	local/regional vs. distant	From baseline up to 42 months
Secondary	Serum levels of nuclear protein Ki67		From baseline up to 42 months
Secondary	Number of participants with metastasis		From baseline up to 42 months
Secondary	Sites of metastases	Lung, brain, liver, peritoneum, bone, lymph nodes, other	From baseline up to 42 months
Secondary	Comorbidities	Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index.	From baseline up to 42 months
Secondary	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)	From baseline up to 42 months
Secondary	Concurrent medical conditions		From baseline up to 42 months
Secondary	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	From baseline up to 42 months
Secondary	Participant Treatment History		From baseline up to 42 months

External Links

•   BMS Clinical Trial Information