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NCT03516981 · ClinicalTrials.gov registry record · Phase 2
A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
NCT03516981 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 245 participants.
The verdict
NCT03516981, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
- BIOLOGICAL Favezelimab
- DRUG Quavonlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2025-06-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03516981
The ClinicalTrials.gov registry entry for NCT03516981 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03516981 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03516981 about?
NCT03516981 is a clinical study titled "A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)". 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 bur...
What is the current status of trial NCT03516981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2018-10-01. Estimated completion is 2025-06-13.
What interventions are being tested in trial NCT03516981?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG), Favezelimab (BIOLOGICAL), Quavonlimab (DRUG).
Who is sponsoring clinical trial NCT03516981?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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