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)

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 re

Trial Details

NCT ID
NCT06469944
Phase
PHASE1 / PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Pembrolizumab
  • Sacituzumab Tirumotecan (sac-TMT)
  • Capecitabine
  • Leucovorin
  • Levoleucovorin
  • 5-Fluorouracil (5-FU)
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Louisville, Kentucky, United States|38.25424,-85.75941
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • East Syracuse, New York, United States|43.06534,-76.07853

Key Eligibility Criteria

  • The main inclusion criteria include but are not limited to the following:
  • Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gas…
  • Is not expected to require tumor resection during the treatment course
  • Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clin…

For full eligibility, visit ClinicalTrials.gov.

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