MelanomaOpen to EnrollmentPhase 2

MELANOMA: NEOADJUVANT: STAGE III: KEYNOTE U02-C

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: Substudy 02C

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Study snapshot

Title: Merck MK-3475-U02C (Neoadjuvant Stage III)
Malignancy: Melanoma, Cutaneous Melanoma
Stage: Stage 3
Disease setting: Neoadjuvant; prior to definitive resection
Line of therapy: Neoadjuvant
Investigational agent: Pembrolizumab, MK-7684, V937
Drug class: Anti-PD-1, Anti-TIGIT, Oncolytic virus
Principal investigator: David Portnoy, MD
Sponsor: Merck Sharp & Dohme Corp
Path: Melanoma
Randomized: Yes
ClinicalTrials.gov ID: NCT04303169

Eligibility and objectives

Key eligibility criteria details

Histologically or cytologically confirmed melanoma
Clinically detectable and resectable Stage IIIB, IIIC, or IIID melanoma
Has been untreated for the melanoma with the exception that primary lesion may have been resected or irradiated
No known CNS mets
No ocular or mucosal melanoma
No known HIV/HBV/HCV
No active autoimmune disease requiring therapy in past 2 years
Must not have received prior oncolytic viruses

Objective

Primary
- pathCR
- Safety
Secondary
- Near pathCR
- Path PR
- RFS

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details