Trial Profile

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 12 Mar 2026

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At a glance

Drugs Fluorouracil (Primary) ; Folinic acid (Primary) ; Ifinatamab deruxtecan (Primary) ; Levofolinic acid (Primary) ; Oxaliplatin (Primary) ; Pembrolizumab (Primary)
Indications Oesophageal cancer; Squamous cell cancer
Focus Adverse reactions; Therapeutic Use
Acronyms KEYMAKER-U06 Substudy 06E
Sponsors Merck Sharp & Dohme

12 Jan 2026 Protocol has been amended to include one new arm (Experimental: Pembrolizumab + Sacituzumab tirumotecan + 5-FU IV + Leucovorin or Levoleucovorin) , it has changed from 4 to 5.
12 Jan 2026 Planned number of patients changed from 228 to 298.
22 Aug 2025 Planned End Date changed from 21 Feb 2031 to 4 Jan 2032.

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