NCT06469944

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (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 tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Detailed description

The master protocol is MK-3475-U06.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Administered via intravenous (IV) infusion.
BIOLOGICAL	Sacituzumab Tirumotecan (sac-TMT)	Administered via IV infusion.
DRUG	Capecitabine	Administered via oral tablet.
DRUG	Leucovorin	Administered via IV infusion.
DRUG	Levoleucovorin	Administered via IV infusion.
DRUG	5-Fluorouracil (5-FU)	Administered via IV infusion
DRUG	Oxaliplatin	Administered via IV infusion
BIOLOGICAL	Patritumab Deruxtecan	Administered via IV infusion

Timeline

• Start date: 2024-09-20
• Primary completion: 2029-09-12
• Completion: 2029-09-12
• First posted: 2024-06-24
• Last updated: 2026-04-13

Locations

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

Regulatory

• FDA-regulated drug study