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 02A

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506312-41-00

Acronym

MK-3475-02A

Enrollment

Registered

2023-12-04

Start date

2020-07-30

Completion date

2025-08-22

Last updated

2025-09-01

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

Conditions

PD-1 refractory melanoma

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) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Detailed description

Duration of response (DOR) per RECIST 1.1

Interventions

DRUGLenvatinib

DRUGquavonlimab

DRUGTRETINOIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGvibostolimab

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) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)	—

Secondary

Measure	Time frame
Duration of response (DOR) per RECIST 1.1	—

Countries

France, Italy

Outcome results

None listed

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