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Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

StatusTerminated
PhasePhase 3
Started2022-03-24
View on ClinicalTrials.gov ↗
Why the trial stopped
MK-7684A-007 was terminated early due to futility. A non-submission CSR, not intended to support any registration, was issued; therefore, an abbreviated CSR was generated.

Amendment history

2026-08-19
Study Status v49
Reclassified as terminated (was completed)
Trial terminated: MK-7684A-007 was terminated early due to futility. A non-submission CSR, not intended to support any registration, was...
2026-01-16
Active, Not Recruiting→Completed Study Status, IPDSharing v48
Trial statusActive, Not Recruiting→Completed
2025-10-29
Study Status, Participant Flow, Outcome Measures (Results) v47
Results first postednot stated→2025-11-13
2025-09-22
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v46
Secondary endpoints18 entries, revised
Overall Survival (OS) in All Participants Change fromFrom Baseline in the Global Health Status/Quality of Life (Items [...] uality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Change fromFrom Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 Change fromFrom Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 Change fromFrom Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 Change fromFrom Baseline in Cough Score (Item 31) on the European Organizat [...] ancer-Specific Questionnaire Module (EORTC QLQ-LC13) Change fromFrom Baseline in Chest P [...]
Primary endpoints1 entry, revised
Overall Survival (OS) in Participants withWith Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
2025-02-07
Study Status, Study Description, Study Design, Outcome Measures v45
Primary completion dateestimated 2026-06-25→confirmed 2024-09-24
Completion date2027-09-27→2026-01-09
Enrollment targetestimated 700→confirmed 739
Secondary endpointsdetails revised at 6 of 18 entries
Study description+537 characters
Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from [...]
Show 44 earlier versions
2024-11-14
Study Identification, Study Status, References v44
Re-verified, no change to tracked fields
2024-06-19
Study Status, Outcome Measures, Eligibility v43
Primary completion date2025-11-10→2026-06-25
Eligibility criteria-18 characters
[...] nfirmed diagnosis of Stage IV squamous or non-squamous NSCLC. Has not received prior systemic treatment for metastatic NSCLC. Has measurable disease based on RECIST 1.1, as determined by the local site assessment. Has a life expectancy of at least 3 months. Males: Use contraception unless confirmed to be azoospermic [...] dbearing potential use highly effective contraceptive method. Exclusion Criteria: Known additional malignancy that is pro [...] ing or has required active treatment within the past 3 years. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Severe hyperse [...] [...]
Secondary endpoints17 to 18 entries
Overall Survival (OS)
Primary endpoints1 entry, revised
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
2024-05-14
Study Identification, Study Status, Outcome Measures, Eligibility v42
Eligibility criteria-198 characters
[...] and/or carcinomatous meningitis. Severe hypersensitivity to vibostolimabMK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its [...] disease that has required systemic treatment in past 2 years (ie, withexcept use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacementreplacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. History of (noninfectious) pneumonitis/interstitial lung di [...]
Secondary endpoints17 entries, revised
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Change from Baseline for Role Functioning Combined (Items 6 and 7) Combined Score on the EORTC QLQ-C30 Change from Baseline in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Change from Baseline in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Quest [...] [...]
2024-01-19
Study Status, References v41
Re-verified, no change to tracked fields
2023-12-07
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, References v40
Eligibility criteria+1 characters
[...] . Administration of killed vaccines are allowed. History of allogenicallogeneic tissue/solid organ transplant. Is unable to interrupt aspir [...]
Secondary endpoints16 to 17 entries
Progression-Free Survival (PFS)
Primary endpoints2 to 1 entries
Progression-Free Survival (PFS)
2023-05-15
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v39
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 149 of 149 sites
2023-03-31
Study Status, Contacts/Locations v38
Study sites144→149
2023-03-03
Study Status, Contacts/Locations v37
Study sites140→144
2023-02-09
Study Status, Contacts/Locations v36
Study sites138→140
2023-02-03
Study Status, Contacts/Locations v35
Study sites135→138
2023-01-27
Study Status v34
Re-verified, no change to tracked fields
2023-01-20
Study Status, Contacts/Locations v33
Study sites130→135
2023-01-12
Study Status, Contacts/Locations v32
Study sites129→130
2023-01-05
Study Status, Contacts/Locations v31
Study sitesdetails revised at 3 of 129 sites
2022-12-23
Study Status, Contacts/Locations v30
Study sites122→129
2022-12-03
Study Status, Contacts/Locations v29
Study sites118→122
2022-11-25
Study Status, Contacts/Locations v28
Study sites116→118
2022-11-18
Study Status, Contacts/Locations v27
Study sites112→116
2022-11-04
Study Status, Contacts/Locations v26
Study sites107→112
2022-10-28
Study Status, Contacts/Locations v25
Study sites106→107
2022-10-14
Study Status, Contacts/Locations v24
Study sites102→106
2022-10-09
Study Status, Contacts/Locations v23
Study sites99→102
2022-09-28
Study Status, Contacts/Locations v22
Study sites92→99
2022-09-17
Study Status, Contacts/Locations v21
Study sites86→92
2022-09-09
Study Status, Contacts/Locations v20
Study sites81→86
2022-09-02
Study Status, Contacts/Locations v19
Study sites75→81
2022-08-22
Study Status, Contacts/Locations v18
Study sites69→75
2022-08-10
Study Status, Contacts/Locations v17
Study sites67→69
2022-08-04
Study Status, Contacts/Locations v16
Study sites65→67
2022-08-01
Study Status, Contacts/Locations v15
Study sites61→65
2022-07-22
Study Status, Contacts/Locations v14
Study sites58→61
2022-07-13
Study Status, Outcome Measures, Contacts/Locations, References v13
Study sites47→58
Secondary endpoints14 to 16 entries
Change from Baseline for Role Functioning Combined (Items 6 and 7) Score on the EORTC QLQ-C30 TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
2022-06-23
Study Status, Contacts/Locations v12
Study sites43→47
2022-06-17
Study Status, Contacts/Locations v11
Study sites39→43
2022-06-10
Study Status, Contacts/Locations v10
Study sites32→39
2022-06-03
Study Identification, Study Status, Contacts/Locations v9
Study sites27→32
2022-05-27
Study Status, Contacts/Locations v8
Study sites25→27
2022-05-19
Study Status, Contacts/Locations v7
Study sites18→25
2022-05-12
Study Status, Contacts/Locations v6
Study sites16→18
2022-04-27
Study Status, Contacts/Locations v5
Study sites14→16
2022-04-22
Study Status, Contacts/Locations v4
Study sites13→14
2022-04-13
Study Status, Contacts/Locations v3
Study sites6→13
2022-04-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-03-28→confirmed 2022-03-24
Study sites0→6
2022-02-16
Study Identification, Study Status v1
Study title+12 characters
[...] nts With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
2022-01-26
Original filing
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
Trial Details
NCT Number NCT05226598
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Metastatic Non-Small Cell Lung Cancer
Enrollment 739 participants
Start Date 2022-03-24
Primary Completion 2024-09-24 (estimated)
Study Completion 2026-01-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-11