Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

Official Title

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)

Details

After Amendment 5, participants can receive 800 mg of favezelimab every 3 weeks (Q3W)

Keywords

Advanced Non-Small Cell Lung Cancer, Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Pembrolizumab, Lenvatinib, Favezelimab, Quavonlimab, GEP low TMB low: Pembrolizumab + Quavonlimab, GEP low TMB low: Pembrolizumab + Favezelimab, GEP low TMB low: Pembrolizumab + Lenvatinib, GEP low TMB hi: Pembrolizumab + Quavonlimab, GEP low TMB hi: Pembrolizumab + Favezelimab, GEP low TMB hi: Pembrolizumab + Lenvatinib, GEP hi TMB low: Pembrolizumab + Quavonlimab, GEP hi TMB low: Pembrolizumab + Favezelimab, GEP hi TMB low: Pembrolizumab + Lenvatinib, GEP hi TMB hi: Pembrolizumab + Quavonlimab, GEP hi TMB hi: Pembrolizumab + Favezelimab, GEP hi TMB hi: Pembrolizumab + Lenvatinib

Eligibility

Locations

  • UCSF ( Site 0111)
    San Francisco California 94143 United States
  • University of California Davis Comprehensive Cancer Center ( Site 0137)
    Sacramento California 95817 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT03516981
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 318 study participants
Last Updated