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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 02C

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506314-51-00
Acronym
MK-3475-02C
Enrollment
29
Registered
2024-02-14
Start date
2020-07-31
Completion date
2025-09-09
Last updated
2025-09-09

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

Conditions

Stage IIIB or IIIC or IIID melanoma

Brief summary

Percentage of participants who experience an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, Pathological complete response (pCR) rate

Detailed description

Near pathological complete response (near pCR) rate, Pathological partial response (pPR) rate, Recurrence-free survival (RFS)

Interventions

DRUGTRETINOIN
DRUGMK-4830
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

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 an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, Pathological complete response (pCR) rate

Secondary

MeasureTime frame
Near pathological complete response (near pCR) rate, Pathological partial response (pPR) rate, Recurrence-free survival (RFS)

Countries

France, Italy

Outcome results

None listed

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