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

NCT05342636 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-27
Primary Completion
2025-12-05
Completion
2025-12-05
FDA Drug
Yes

Countries

  • Brazil
  • Chile
  • France
  • Germany
  • Italy
  • Japan
  • Norway
  • Singapore
  • South Korea
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05342636 on ClinicalTrials.gov