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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506313-21-00
Acronym
MK-3475-02B
Enrollment
71
Registered
2024-02-16
Start date
2020-08-03
Completion date
Unknown
Last updated
2025-11-21

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 a dose-limiting toxicity (DLT) during safety lead-in phase, Percentage of participants who experience an adverse event (AE) during safety lead-in phase, Percentage of participants who discontinue study treatment due to an AE during safety lead-in phase, 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

DRUGMK-1308A
DRUGLenvatinib
DRUGMK-4280A
DRUGvibostolimab
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGTRETINOIN

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants who experience a dose-limiting toxicity (DLT) during safety lead-in phase, Percentage of participants who experience an adverse event (AE) during safety lead-in phase, Percentage of participants who discontinue study treatment due to an AE during safety lead-in phase, 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

MeasureTime frame
Duration of response (DOR) per RECIST 1.1—

Countries

France, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

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