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

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505189-26-00

Acronym

MK-3475-06B

Enrollment

Registered

2024-06-24

Start date

2023-03-28

Completion date

Unknown

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced esophageal squamous cell carcinoma

Brief summary

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) During Safety Lead-in Phase, Number of Participants Who Experienced an Adverse Event (AE) During Safety Lead-in Phase, Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase, Objective Response Rate (ORR)

Detailed description

Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS), Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase, Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase

Interventions

DRUGPACLITAXEL

DRUGLenvatinib

DRUGMK-4830

DRUGFAMOTIDINE

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPARACETAMOL

DRUGIRINOTECAN

DRUG-

DRUGMK-2870

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) During Safety Lead-in Phase, Number of Participants Who Experienced an Adverse Event (AE) During Safety Lead-in Phase, Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase, Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS), Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase, Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase	—

Countries

Germany, Italy, Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026