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 naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505188-36-00

Acronym

MK-3475-06A

Enrollment

Registered

2024-07-09

Start date

2022-09-09

Completion date

2025-09-03

Last updated

2025-10-20

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 (ESCC)

Brief summary

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase., Number of Participants Experiencing 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

DRUGIRINOTECAN

DRUGLenvatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-4830

DRUGPACLITAXEL

DRUGMK-4280A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase., Number of Participants Experiencing 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

France, Germany, Italy, Norway

Outcome results

None listed

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