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A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507294-18-00
Acronym
MK-3475-426
Enrollment
269
Registered
2023-12-14
Start date
2016-09-16
Completion date
2025-09-11
Last updated
2025-09-10

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

Conditions

Metastatic renal cell carcinoma

Brief summary

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Overall Survival (OS)

Detailed description

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants, Overall Survival (OS) Rate at Month 12 in All Participants, Overall Survival (OS) Rate at Month 18 in All Participants, Overall Survival (OS) Rate at Month 24 in All Participants, Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score, Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGSUNITINIB
DRUGAXITINIB

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Overall Survival (OS)

Secondary

MeasureTime frame
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants, Overall Survival (OS) Rate at Month 12 in All Participants, Overall Survival (OS) Rate at Month 18 in All Participants, Overall Survival (OS) Rate at Month 24 in All

Countries

Czechia, France, Germany, Hungary, Ireland, Poland, Spain

Outcome results

None listed

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