MELANOMA: Metastatic: PD-1 refractory: KEYNOTE-U02-A

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 02A.

Title
Merck MK-3475-U02A (PD-1 Refractory 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 02A.

Site Link
Malignancy
Melanoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd Line (post PD-1)
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 curative therapy
  • Has progressed on treatment with an anti-PD1/L1 monoclonal antibody administered either as monotherapy or in combination with other therapies
  • Hsa not received more than 3 lines of therapy
  • No known additional malignancy with past 2 years
  • No known CNS metastases
  • No active autoimmune disease requiring systemic treatment in the last 2 years
  • No known HIV/HBV/HCV
Objective
  • Primary
    • Safety
    • ORR
  • Secondary
    • DOR
    •  
Assessment Frequency
_
Assessment Frequency 2
_



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