West Cancer Center

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

NCT03396445

Malignancy

Lung cancer, non-squamous lung cancer, NSCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line (or 2nd line in rare cases)

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

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized