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A Multicenter, Open-label, Phase 2 Basket Study of MK‑7684A, a Co formation of Vibostolimab (MK‑7684) With Pembrolizumab (MK‑3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (KEYVIBE 005)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505284-36-00
Acronym
MK-7684A-005
Enrollment
228
Registered
2024-02-06
Start date
2021-09-13
Completion date
2025-06-27
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumors

Brief summary

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, ORR per RECIST 1.1 as Assessed by Investigator, PFS per RECIST 1.1 as Assessed by Investigator at 9 months, PFS per RECIST 1.1 as Assessed by Investigator at 12 months

Detailed description

Overall Survival (OS), PFS per RECIST 1.1 as Assessed by Investigator, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, DOR per RECIST 1.1 as Assessed by Investigator, ORR per RECIST 1.1 as Assessed by Investigator, Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30), Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5), Number of Participants Who Experienced One or More Adverse Events (AEs)

Interventions

DRUGPACLITAXEL
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDOCETAXEL
DRUGLenvatinib
DRUGBEVACIZUMAB
DRUGCAPECITABINE
DRUGCARBOPLATIN
DRUGFLUOROURACIL
DRUGOXALIPLATIN
DRUGGEMCITABINE
DRUGCISPLATIN

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, ORR per RECIST 1.1 as Assessed by Investigator, PFS per RECIST 1.1 as Assessed by Investigator at 9 months, PFS per RECIST 1.1 as Assessed by Investigator at 12 months

Secondary

MeasureTime frame
Overall Survival (OS), PFS per RECIST 1.1 as Assessed by Investigator, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, DOR per RECIST 1.1 as Assessed by Investigator, ORR per RECIST 1.1 as Assessed by Investigator, Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30), Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5), Number of Participants Who Experienced One or More Adverse Events (AEs)

Countries

France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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