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)

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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

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.

Sponsors & Collaborators

• 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

2023-05-16

Primary Completion

2027-06-11

Completion

2029-04-10

FDA Drug

Yes

Countries

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

Study Locations