BREAST: METASTATIC: TNBC: PHASE 1: 2nd/3rd LINE: MK-5890-01-ARM2A

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

Title
Merck MK-5890-001 (TNBC PHASE 1)
Study Title

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

Site Link
Malignancy
Breast, Triple Negative Breast Cancer, TNBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd or 3rd line
Investigational Agent
MK-5890
Drug Class
CD27 agonist
PI
Dan Vaena, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Must have measurable disease by RECIST 1.1
  • Diagnosis of TNBC
  • Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
  • Prior therapy should have included anthracycline and/or taxane
  • LDH must be <2x ULN at screening
  • May be PD-L1 treatment refractory (number capped)
  • ECOG PS 0-1
  • No 2nd malignancy within 2 years
  • No active CNS involvement
  • No history of interstitial lung disease
  • No active pneumonitis or history of non-infectious pneumonitis that required steroids
  • No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
  • No known HIV, HBV, HCV
  • No need for steroids at dose of greater than 10mg prednisone or equivalent daily
  • No recent history of substance abuse
Objective
  • Primary- RP2D
  • Secondary- 
    • ORR
    • Safety
  • Tertiary
    • PFS
    • OS
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
ER negative, PR negative, HER2 negative
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X