NCT05342636

A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.

Detailed description

The master protocol is MK-3475-U06.

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
BIOLOGICAL	Coformulation favezelimab/pembrolizumab	800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
BIOLOGICAL	MK-4830	800 mg administered via IV infusion Q3W
DRUG	Lenvatinib	20 mg administered via oral capsules each day
DRUG	Irinotecan	180 mg/m\^2 administered via IV infusion on day 1 of every 14-day cycle.
DRUG	Paclitaxel	80-100 mg/m\^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle

Timeline

• Start date: 2022-07-27
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2022-04-22
• Last updated: 2025-12-17

Locations

46 sites across 13 countries: Brazil, Chile, France, Germany, Italy, Japan, Norway, Singapore, South Korea, Switzerland, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study