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

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.

Trial Details

NCT ID
NCT06445972
Phase
PHASE1 / PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Ramucirumab
  • Paclitaxel
  • Sacituzumab Tirumotecan
  • Rescue Medications
  • HER3-DXd
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 treated, second line (2L) (received first line (1L) treatment) gastric ad…
  • Has metastatic disease or locally advanced, unresectable disease
  • Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum/fluoropyrimidi…

For full eligibility, visit ClinicalTrials.gov.

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