Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)

Summary

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.

Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.

Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

BIOLOGICAL

I-DXd

IV infusion

DRUG

Leucovorin

IV infusion

DRUG

Levoleucovorin

IV infusion

DRUG

5-Fluorouracil (5-FU)

IV Infusion

DRUG

Oxaliplatin

IV infusion

BIOLOGICAL

Sacituzumab tirumotecan

IV infusion

DRUG

Rescue Medication

Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, and dexamethasone for Arm 5, administered per approved product label

Sponsors & Collaborators

• Daiichi Sankyo

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  lead INDUSTRY

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

2025-07-30

Primary Completion

2032-01-04

Completion

2032-01-04

FDA Drug

Yes

Countries

• United States
• Brazil
• Chile
• China
• Czechia
• France
• Germany
• Italy
• Japan
• Norway
• Singapore
• South Korea
• Switzerland
• Taiwan
• Thailand

Study Locations