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

Title
Merck MK-3475-U02C (Neoadjuvant Stage III)
Study Title

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

Site Link
Malignancy
Melanoma, Cutaneous Melanoma
Stage
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
PI
David Portnoy, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
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
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Melanoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X