West Cancer Center

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

NCT03396445

Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd or 3rd line

Investigational Agent

MK-5890

Drug Class

CD27 agonist

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Phase

Phase 1

Status

Closed to Accrual

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER negative, PR negative, HER2 negative

Dosing Frequency

Control Agents

Study Protocol

Randomized