NCT05319730

A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)

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 Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.

Detailed description

The master protocol is MK-3475-U06. As of Protocol Amendment 5, the Pembrolizumab Plus MK-4830 Plus Paclitaxel/Irinotecan arm and the Pembrolizumab Plus MK-4830 Plus Lenvatinib arm are no longer actively enrolling participants.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.
DRUG	Irinotecan	180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.
BIOLOGICAL	Pembrolizumab	200 mg IV infusion, administered every Q3W up to 35 infusions.
BIOLOGICAL	MK-4830	800 mg IV infusion, administered Q3W up to 35 infusions.
DRUG	Lenvatinib	20 mg oral administration every day.
BIOLOGICAL	Sacituzumab tirumotecan	4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.
DRUG	Antihistamine	Administered per product label.
DRUG	H2 Receptor Antagonist	Administered per product label.
DRUG	Acetaminophen (or equivalent)	Administered per product label.
DRUG	Dexamethasone (or equivalent)	Administered per product label.
DRUG	Steroid Mouthwash (dexamethasone or equivalent)	Administered per product label.
DRUG	Supportive care measures	Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or ointment may be given as a supportive care for Ocular Surface Toxicity.

Timeline

• Start date: 2023-05-16
• Primary completion: 2027-06-11
• Completion: 2029-04-10
• First posted: 2022-04-08
• Last updated: 2026-03-20

Locations

57 sites across 14 countries: United States, Brazil, Chile, China, Germany, Italy, Japan, Norway, Singapore, South Korea, Switzerland, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study