MELANOMA:Metastatic: 1st Line: KEYNOTE-U02-B

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02B.

Title
Merck MK-3475-U02B (PD-1 naive metastatic melanoma)
Study Title

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02B.

Site Link
Malignancy
Melanoma, Cutaneous Melanoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line, PD-1 naive
Investigational Agent
Multiple
Drug Class
PI
David Portnoy, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has been untreated for advanced disease
  • No ocular or mucosal melanoma
  • No known additional malignancy that is progressing or requires active treatment within the past two years
  • No known CNS metastatses
  • No active autoimmune disease requiring systemic treatment in the past two years
  • No known HIV/HBV/HCV
  • Adequate organ function
Objective
  • Primary
    • ORR
    • AE
  • Secondary
    • DoR
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Melanoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X