drugset / Trial / NCT06356311

A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

NCT06356311

Phase 3 Active not recruiting 450 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).

Timeline

Start
2024-05-03
Primary completion
2027-01-04
Completion
2027-05-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Irinotecan Small molecule 150 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous
Comparator TAS-102 Small molecule 35 mg/m2 Oral
Background Acetaminophen Small molecule
Background Dexamethasone Small molecule Topical
Background Nystatin Unknown Oral