A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
Public ClinicalTrials.gov record NCT03516981. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03516981
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 245 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Favezelimab Biological
- Lenvatinib Drug
- Quavonlimab Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2018
- Primary completion
- Jun 12, 2025
- Completion
- Jun 12, 2025
- Last update posted
- Jun 7, 2026
2018 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, PC- HAL ( Site 8001) | Tempe | Arizona | 85284 | — |
| University of California Davis Comprehensive Cancer Center ( Site 0137) | Sacramento | California | 95817 | — |
| University of California San Francisco ( Site 0111) | San Francisco | California | 94143 | — |
| UCLA Hematology/Oncology -Santa Monica ( Site 0108) | Santa Monica | California | 90404 | — |
| Yale University School of Medicine ( Site 0100) | New Haven | Connecticut | 06520 | — |
| Mayo Clinic Florida ( Site 0115) | Jacksonville | Florida | 32224 | — |
| University of Maryland ( Site 0136) | Baltimore | Maryland | 21201 | — |
| Mayo Clinic Rochester - St. Mary's Hospital ( Site 0117) | Rochester | Minnesota | 55905 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0112) | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0113) | New York | New York | 10065 | — |
| Weill Cornell Medical College ( Site 0138) | New York | New York | 10065 | — |
| Oncology Hematology Care ( Site 8005) | Cincinnati | Ohio | 45242 | — |
| University of Pennsylvania ( Site 0132) | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Cancer Center/Hillman Cancer Center ( Site 0104) | Pittsburgh | Pennsylvania | 15232 | — |
| Texas Oncology-Memorial City ( Site 8006) | Houston | Texas | 77024 | — |
| Texas Oncology-Tyler ( Site 8003) | Tyler | Texas | 75702 | — |
| Emily Couric Clinical Cancer Center ( Site 0134) | Charlottesville | Virginia | 22903 | — |
| Northwest Cancer Specialists, P.C. ( Site 8000) | Vancouver | Washington | 98684 | — |
| University of Wisconsin- Madison Carbone Cancer Center ( Site 0130) | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03516981, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 7, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03516981 live on ClinicalTrials.gov.