Adjuvant Therapy with Pembrolizumab versus Placebo in Resected Highrisk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501966-23-00

Acronym

MK-3475-716

Enrollment

530

Registered

2023-09-25

Start date

2018-09-11

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Resected High-Risk Stage II Melanoma

Brief summary

Recurrence-free Survival (RFS)

Detailed description

Distant Metastasis-free Survival (DMFS), Overall Survival (OS), Number of Participants Who Experienced at Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPlacebo to Keytruda - Normal saline

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-free Survival (RFS)	—

Secondary

Measure	Time frame
Distant Metastasis-free Survival (DMFS), Overall Survival (OS), Number of Participants Who Experienced at Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE	—

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed

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