A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500990-16-00

Acronym

MK-3475-495

Enrollment

Registered

2024-03-22

Start date

2018-12-19

Completion date

2025-06-13

Last updated

2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV non-small cell lung cancer

Brief summary

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Detailed description

Progression Free Survival (PFS) per RECIST 1.1, Overall Survival (OS), Number of Participants Experiencing Adverse Events (AEs), Number of Participants Discontinuing Study Drug Due to AEs

Interventions

DRUGfavezelimab

DRUGquavonlimab

DRUGLenvatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)	—

Secondary

Measure	Time frame
Progression Free Survival (PFS) per RECIST 1.1, Overall Survival (OS), Number of Participants Experiencing Adverse Events (AEs), Number of Participants Discontinuing Study Drug Due to AEs	—

Countries

Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026