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Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

StatusTerminated
PhasePhase 3
Started2021-04-07
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 142 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-18
Reclassified as terminated (was completed)
Trial terminated: Business Reasons
2026-06-23
Study Status v141
Re-verified, no change to tracked fields
2026-02-03
Active, Not Recruiting→Completed Study Status v140
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2026-01-26→confirmed 2026-01-27
2025-08-06
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v139
Completion date2025-12-31→2026-01-26
Results first postednot stated→2025-08-26
Secondary endpoints49 entries, revised
Change fromFrom Baseline in Global Health Status/Quality of Life (QoL) (Ite [...] (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50% Change fromFrom Baseline in Global Health Status/QoL (Items 29, 30) Combine [...] RTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Change fromFrom Baseline in Global Health Status/QoL (Items 29, 30) Combine [...] the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Change fromFrom Baseline in Physical Functioning (Items 1-5) Combined Score [...] he EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Change fromFrom Baseline in Physical Functioning (Items 1-5) Combined Score [...] RTC QLQ-C30 i [...]
Primary endpoints1 entry, revised
Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Study description+335 characters
The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 05-Sep-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 58 participants enrolled after the primary completion date and will be ana [...]
2025-03-25
Study Identification, Study Status, IPDSharing v138
Primary completion dateestimated 2026-12-18→confirmed 2024-09-05
Completion date2026-12-18→2025-12-31
Show 45 earlier versions
2024-11-06
Study Status, References v137
Re-verified, no change to tracked fields
2024-10-28
Study Identification, Study Status, Study Design, Outcome Measures v136
Primary completion date2026-04-21→2026-12-18
Completion date2028-06-05→2026-12-18
Enrollment targetestimated 1246→confirmed 1264
Secondary endpoints45 to 49 entries
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%
Primary endpoints5 to 1 entries
OS in Participants With PD-L1 TPS 1% to 49% OS in Participants With PD-L1 TPS ≥1% PFS in Participants With PD-L1 TPS ≥50% Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
2024-10-04
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v135
Trial statusRecruiting→Active, Not Recruiting
Study sites189→188
2024-09-19
Study Status, Contacts/Locations v134
Study sitesdetails revised at 1 of 189 sites
2024-09-10
Study Status, Contacts/Locations v133
Study sites198→189
2024-08-21
Study Identification, Study Status, Contacts/Locations v132
Study sitescontacts updated at 1 of 198 sites
2024-07-31
Study Status, Contacts/Locations v131
Study sitesdetails revised at 1 of 198 sites
2024-07-26
Study Status, Contacts/Locations v130
Study sitesdetails revised at 2 of 198 sites
2024-07-18
Study Status, Contacts/Locations v129
Study sitesdetails revised at 1 of 198 sites
2024-07-10
Study Status, Contacts/Locations v128
Study sites196→198
2024-06-28
Study Status, Study Description, Contacts/Locations v127
Study sites194→196
2024-06-19
Study Status, Contacts/Locations v126
Study sitesdetails revised at 1 of 194 sites
2024-06-12
Study Status, Contacts/Locations v125
Study sitesdetails revised at 14 of 194 sites
2024-06-06
Study Status, Contacts/Locations v124
Study sitesdetails revised at 8 of 194 sites
2024-05-29
Study Status, Contacts/Locations v123
Study sitesdetails revised at 2 of 194 sites
2024-05-22
Study Status, Contacts/Locations v122
Study sitesdetails revised at 1 of 194 sites
2024-05-16
Study Status, Contacts/Locations v121
Study sitesdetails revised at 1 of 194 sites
2024-05-08
Study Status, Contacts/Locations v120
Study sites192→194
2024-04-24
Study Status, Contacts/Locations v119
Study sitesdetails revised at 1 of 192 sites
2024-04-18
Study Status, Contacts/Locations v118
Study sitesdetails revised at 4 of 192 sites
2024-04-10
Study Status, Contacts/Locations v117
Study sitescontacts updated at 1 of 192 sites
2024-04-04
Study Status, Contacts/Locations v116
Study sites192 entries, revised
Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)
2024-03-21
Study Status, Contacts/Locations v115
Study sites192 entries, revised
TorokbalintReformatus Tudogyogyintezet-Onkopulmonologiai JarobetegPulmonologiai Centrum ( Site 1208)
2024-03-06
Study Status, Contacts/Locations v114
Study sites191→192
2024-02-22
Study Status, Contacts/Locations v113
Study sitesdetails revised at 2 of 191 sites
2024-02-14
Study Status, Contacts/Locations v112
Study sitesdetails revised at 2 of 191 sites
2024-02-08
Study Status, Contacts/Locations v111
Study sites190→191
2024-02-01
Study Status, Contacts/Locations v110
Study sitesdetails revised at 2 of 190 sites
2024-01-24
Study Status, Contacts/Locations v109
Study sitesdetails revised at 1 of 190 sites
2024-01-18
Study Status, Contacts/Locations v108
Study sitesdetails revised at 4 of 190 sites
2024-01-10
Study Status, Contacts/Locations v107
Study sitesdetails revised at 1 of 190 sites
2024-01-05
Study Status, Contacts/Locations v106
Study sitesdetails revised at 1 of 190 sites
2023-12-27
Study Status, Contacts/Locations v105
Study sitesdetails revised at 2 of 190 sites
2023-12-21
Study Status, Contacts/Locations v104
Study sitesdetails revised at 1 of 190 sites
2023-12-13
Study Status, Contacts/Locations, References v103
Study sitesdetails revised at 1 of 190 sites
2023-12-06
Study Status, Contacts/Locations v102
Study sitesdetails revised at 5 of 190 sites
2023-11-30
Study Status, Contacts/Locations v101
Study sitesdetails revised at 2 of 190 sites
2023-11-22
Study Status, Contacts/Locations v100
Study sites189→190
2023-11-09
Study Status, Contacts/Locations v99
Study sitesdetails revised at 3 of 189 sites
2023-11-03
Study Status, Contacts/Locations v98
Study sitesdetails revised at 1 of 189 sites
2023-10-25
Study Status, Contacts/Locations v97
Study sitesdetails revised at 6 of 189 sites
2023-10-18
Study Status, Contacts/Locations v96
Study sitesdetails revised at 3 of 189 sites
2023-10-13
Study Status, Contacts/Locations v95
Study sites187→189
2023-09-27
Study Status, Contacts/Locations v94
Study sitesdetails revised at 6 of 187 sites
2023-09-14
Study Identification, Study Status, Contacts/Locations v93
Study sites186→187
Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
Trial Details
NCT Number NCT04738487
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Enrollment 1,264 participants
Start Date 2021-04-07
Primary Completion 2024-09-05 (estimated)
Study Completion 2026-01-27 (estimated)
Updated on ClinicalTrials.gov 2026-09-17