A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506315-17-00

Acronym

MK-3475-02D

Enrollment

Registered

2024-01-23

Start date

2021-06-25

Completion date

2025-10-17

Last updated

2025-11-24

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

Conditions

Advanced melanoma with brain metastases, PD-1 refractory or PD-1 naive

Brief summary

Percentage of Participants who Experience an Adverse Event (AE), Percentage of Participants who Discontinue Study Treatment Due to an AE, Objective Response Rate (ORR)

Detailed description

Duration of Response (DOR), Brain Metastasis Response Rate (BMRR), Brain Metastasis Duration of Response (BM-DOR), Progression-free Survival (PFS)

Interventions

DRUGLenvatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-1308A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of Participants who Experience an Adverse Event (AE), Percentage of Participants who Discontinue Study Treatment Due to an AE, Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
Duration of Response (DOR), Brain Metastasis Response Rate (BMRR), Brain Metastasis Duration of Response (BM-DOR), Progression-free Survival (PFS)	—

Countries

France, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

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