LUNG: METASTATIC: PHASE 1: ADENOCA: 1ST LINE: MK-5890-001-ARM3

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 (LUNG 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
Lung cancer, non-squamous lung cancer, NSCLC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line (or 2nd line in rare cases)
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
  • Histologically or cytologicall confirmed Stage IV (M1a or M1b) non-squamous NSCLC
    • Mixed histologies allowed if predominant type non-squamous
    • No small cell allowed (even if non-predominant part of mixed histology)
    • May be untreated or could have received 1 prior regimen
    • EGFR or ALK positive should have had prior treatment with TKI
  • No prior radiation therapy to the lung >30Gy within past 6 months
  • Must have measurable disease by RECIST 1.1
  • 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
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Assessment Frequency Link
Path
Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X