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A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 with Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer (KEYVIBE-003)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505362-28-00
Acronym
MK-7684A-003
Enrollment
156
Registered
2023-10-23
Start date
2021-04-21
Completion date
2026-01-20
Last updated
2025-09-02

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

Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%

Detailed description

OS in Participants With PD-L1 TPS ≥1%, OS in Participants With PD-L1 TPS 1% to 49%, Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS ≥50%, Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS 1% to 49%, ORR in Participants With PD-L1 TPS ≥50%, ORR in Participants With PD-L1 TPS 1% to 49%, Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%, DOR in Participants With PD-L1 TPS 1% to 49%, DOR in Participants With PD-L1 TPS ≥1%, Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%

Secondary

MeasureTime frame
OS in Participants With PD-L1 TPS ≥1%, OS in Participants With PD-L1 TPS 1% to 49%, Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS ≥50%, Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS 1% to 49%, ORR in Participants With PD-L1 TPS ≥50%, ORR in Participants With PD-L1 TPS 1% to 49%, Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%, DOR in Participants With PD-L1 TPS 1% to 49%, DOR in Participants With PD-L1 TPS ≥1%, Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Role Functioning (Items 6, 7) Combined Score on th

Countries

Hungary, Romania

Outcome results

None listed

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