A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500395-57-00

Acronym

MK-3475-630

Enrollment

267

Registered

2023-01-18

Start date

2019-03-04

Completion date

Unknown

Last updated

2025-10-08

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

Conditions

Resectable high-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC)

Brief summary

Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy

Detailed description

Overall Survival (OS), Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score, Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score, Percentage of Participants Who Experience an Adverse Event (AE), Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

Interventions

DRUGPlacebo to keytruda - Normal saline solution

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy	—

Secondary

Measure	Time frame
Overall Survival (OS), Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score, Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score, Percentage of Participants Who Experience an Adverse Event (AE), Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	—

Measure

Time frame

—

Countries

France, Germany, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Romania, Spain

Outcome results

None listed

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