Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Melanoma, Stage IIMelanoma Stage III
Interventions
BIOLOGICAL

FYB206

FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle

BIOLOGICAL

Keytruda

Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle

Trial Locations (17)

Unknown

Formycon Investigative Site, Sarajevo

Formycon Investigative Site, Sofia

Formycon Investigative Site, Tartu

Formycon Investigative Site, Batumi

Formycon Investigative Site, Kutaisi

Formycon Investigative Site, Tbilisi

Formycon Investigative Site, Kaunas

Formycon Investigative Site, Chisinau

Formycon Investigative Site, Skopje

Formycon Investigative Site, Krakow

Formycon Investigative Site, Lodz

Formycon Investigative Site, Bucharest

Formycon Investigative Site, Cluj-Napoca

Formycon Investigative Site, Belgrade

Formycon Investigative Site, Kragujevac

Formycon Investigative Site, Niš

Formycon Investigative Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Formycon AG

INDUSTRY

NCT06551064 - Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients | Biotech Hunter | Biotech Hunter