NCT06356311

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

A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician's Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastroesophageal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab tirumotecan	Participants will receive sacituzumab tirumotecan as 4mg/kg IV infusion on days 1, 15, and 29 of every 42-day cycle.
DRUG	Trifluridine-Tipiracil	Trifluridine-tipiracil will be administered at 35 mg/m\^2 as tablet orally twice a day on days 1-5 and 8-12 of every 28-day cycle.
DRUG	Irinotecan	Irinotecan will be administered at a dose of 150 mg/m\^2 by IV infusion on days 1 and 15 of every 28-day cycle.
DRUG	Paclitaxel	Paclitaxel will be administered at a dose of 80 mg/m\^2 by IV infusion on days 1, 8 and 15 of every 28-day cycle.
DRUG	Docetaxel	Docetaxel will be administered at a dose of 75 mg/m\^2 by IV infusion on day 1 of a 21-day cycle.
DRUG	Rescue medications	Participants are required to receive prophylactic mouthwash (steroid mouthwash \[dexamethasone or equivalent\] is highly recommended) to mitigate the onset and severity of stomatitis or oral mucositis. Additionally, participants may receive mucoadhesive hydrogel and oral nystatin suspension or other topical antifungal agents. Additional recommended rescue medications are histamine-1 (H1) receptor antagonist, H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, at the investigator's discretion.
DRUG	Supportive care measures	Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

Timeline

• Start date: 2024-05-03
• Primary completion: 2027-01-04
• Completion: 2027-05-06
• First posted: 2024-04-10
• Last updated: 2026-02-27

Locations

168 sites across 24 countries: United States, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Peru, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study