A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Untreated Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514273-22-00

Acronym

MK-3475-06E

Enrollment

Registered

2025-04-07

Start date

2025-09-02

Completion date

Unknown

Last updated

2025-09-05

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

Conditions

Esophageal squamous cell carcinoma

Brief summary

Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase, Percentage of Participants who Experience an Adverse Event (AE), Percentage of Participants Who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR)

Detailed description

Duration of response (DOR), Progression-free survival (PFS), Overall survival (OS), Disease control rate (DCR), Maximum plasma concentration (Cmax) of ifinatamab deruxtecan (I-DXd), Time to maximum plasma concentration (Tmax) of I-DXd, Area Under the Concentration-Time Curve from Time 0 to Last Measurable Plasma Concentration (AUC0-Last) of I-DXd., Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUC-tau) of I-DXd, The Percentage of participants with antidrug antibodies (ADA) against I-DXd., The Percentage of participants with treatment-emergent ADA against I-DXd.

Interventions

DRUG-

DRUGPARACETAMOL

DRUGCALCIUM FOLINATE

DRUGCALCIUM LEVOFOLINATE

DRUGIfinatamab Deruxtecan

DRUGFLUOROURACIL

DRUGOXALIPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase, Percentage of Participants who Experience an Adverse Event (AE), Percentage of Participants Who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
Duration of response (DOR), Progression-free survival (PFS), Overall survival (OS), Disease control rate (DCR), Maximum plasma concentration (Cmax) of ifinatamab deruxtecan (I-DXd), Time to maximum plasma concentration (Tmax) of I-DXd, Area Under the Concentration-Time Curve from Time 0 to Last Measurable Plasma Concentration (AUC0-Last) of I-DXd., Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUC-tau) of I-DXd, The Percentage of participants with antidrug antibodies (ADA) against I-DXd., The Percentage of participants with treatment-emergent ADA against I-DXd.	—

Measure

Time frame

—

Countries

Czechia, France, Germany, Italy, Norway

Outcome results

None listed

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