A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501971-24-00

Acronym

MK-3475-937

Enrollment

260

Registered

2023-06-19

Start date

2019-05-20

Completion date

2025-07-29

Last updated

2025-09-05

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

Conditions

Adjuvant treatment of HCC

Brief summary

Recurrence-Free Survival (RFS), Overall Survival (OS)

Detailed description

Percentage of participants who experience an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Overall Scores and Subscale Scores, Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score, Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPlacebo to Keytruda - Normal saline

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-Free Survival (RFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
Percentage of participants who experience an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Overall Scores and Subscale Scores, Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score, Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score	—

Measure

Time frame

—

Countries

Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Norway, Poland, Spain, Sweden

Outcome results

None listed

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