Abstract 502TiP
Background
EC is among the top 10 most diagnosed cancers and is the sixth leading cause of cancer mortality globally. Despite curative intent, the rate of disease recurrence remains high after neoadjuvant therapy. Adjuvant nivolumab was established as standard of care for resectable, locally advanced EC/GEJC in CheckMate 577, a randomised, double-blind, placebo-controlled, phase 3 trial. However, real-world data are scarce. PROSPECT-ESO aims to assess treatment patterns and outcomes in patients with EC/GEJC initiating adjuvant nivolumab in routine clinical practice.
Trial design
This prospective, real-world study includes adults with early-stage EC/GEJC receiving adjuvant nivolumab in Germany and the US. The estimated sample size required to observe a 40% reduction in disease-free survival (DFS) is 136 patients. Patients will be selected from sites representing a variety of medical practices; 20 of 26 planned sites are currently active. As of March 2024, 21 patients have been enrolled: 11 in Germany and 10 in the US. Exclusion criteria include current enrolment in a clinical trial and prior therapy with immuno-oncology agents. Nivolumab initiation is at the discretion of the treating physician. Patients will be followed for 24−42 months until end of study period, death, loss to follow-up, or withdrawal, whichever occurs first. The primary outcome is DFS; secondary outcomes include survival (overall; distant metastasis-free), patterns (treatment; disease recurrence), sociodemographic & clinical characteristics, and adverse events; exploratory outcomes are patient satisfaction and health-related quality of life. Molecular and immune predictors to adjuvant nivolumab will be explored in future studies using biomarker data. Assessments will proceed as per local routine practice. Patient data will be captured using an electronic case report form. Data analysis will be mainly descriptive. Findings from this study will generate vital data on adjuvant nivolumab for EC/GEJC in routine practice, offering clinicians further guidance on optimising the management of these patients.
Clinical trial identification
NCT05780736.
Editorial acknowledgement
Writing and editorial assistance were provided by LATITUDE (Powered by AXON), funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
M.A. Shah: Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Merck Inc., Oncolys Biopharma; Financial Interests, Institutional, Other, Consulting fees: Sanofi Aventis. A. Saeed: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Merck, Clovis, Exelixis, Actuate Therapeutics, Incyte Corporation, Daiichi Sankyo, Five prime therapeutics, Amgen, Innovent biologics, Dragonfly therapeutics, Oxford Biotherapeutic, Arcus therapeutics, KAHR medical; Financial Interests, Personal, Leadership Role: Autem therapeutics, Exelixis, KAHR medical, Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, Merck, Exelixis, Pfizer, Xilio Therapeutics, Taiho, Amgen, Autem therapeutics, KAHR medical, Daiichi Sankyo, Arcus Therapeutics. S. Kakehi: Financial Interests, Institutional, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Institutional, Stocks/Shares: Bristol Myers Squibb. R.J. Kelly: Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Institutional, Other, Consulting fees: Bristol Myers Squibb; Financial Interests, Institutional, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Bristol Myers Squibb; Financial Interests, Institutional, Other, Support for attending meetings and/or travel: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb. K. Kondo: Financial Interests, Institutional, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Institutional, Stocks/Shares: Bristol Myers Squibb. M. Herber: Financial Interests, Institutional, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Institutional, Stocks/Shares: Bristol Myers Squibb. A. Stein: Financial Interests, Institutional, Other, Writing support: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Institutional, Other, Consulting fees: Bristol Myers Squibb; Financial Interests, Institutional, Other, Honoraria for lectures: Bristol Myers Squibb. Z. Khan: Financial Interests, Institutional, Full or part-time Employment: PPD, part of Thermo Fisher Scientific. I. Sestak: Financial Interests, Institutional, Full or part-time Employment: PPD, Part of Thermo Fisher Scientific. Y. Halchenko: Financial Interests, Institutional, Full or part-time Employment: Evidera/PPD/ThermoFisher. C. Davis: Financial Interests, Institutional, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Institutional, Stocks/Shares: Bristol Myers Squibb. P. Singh: Financial Interests, Institutional, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Institutional, Stocks/Shares: Bristol Myers Squibb.