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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)

NCT06469944 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2029-09-12
Completion
2029-09-12
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • China
  • France
  • Germany
  • Italy
  • Norway
  • South Korea
  • Switzerland
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469944 on ClinicalTrials.gov