NCT06445972

Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Detailed description

This is a substudy of the master protocol MK-3475-U06 (KEYMAKER-U06).

Conditions

• Gastroesophageal Junction
• Gastroesophageal Adenocarcinoma
• Esophageal Neoplasms
• Esophageal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ramucirumab	8 mg/kg IV Infusion
DRUG	Paclitaxel	80 mg/M\^2 IV infusion
BIOLOGICAL	Sacituzumab Tirumotecan	3 mg/kg or 4 mg/kg IV Infusion
DRUG	Rescue Medications	Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.
BIOLOGICAL	HER3-DXd	IV Infusion

Timeline

• Start date: 2024-08-07
• Primary completion: 2028-05-09
• Completion: 2030-08-08
• First posted: 2024-06-06
• Last updated: 2026-04-02

Locations

43 sites across 11 countries: United States, Brazil, Chile, China, France, Germany, Italy, Norway, South Korea, Switzerland, Taiwan

Regulatory

• FDA-regulated drug study