Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®

PHASE3SuspendedINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Melanoma
Interventions
DRUG

JPB898 (Induction and Maintenance)

Induction and Maintenance: Intravenous (IV)

DRUG

Opdivo-EU (Induction)

Induction: Intravenous (IV)

DRUG

Opdivo-US (Induction)

Induction: Intravenous (IV)

DRUG

Yervoy-EU (Induction)

Induction: Intravenous (IV)

DRUG

Opdivo-EU (Maintenance)

Maintenance: Intravenous (IV)

Trial Locations (57)

Unknown

Sandoz Investigational Site, Sofia

Sandoz Investigational Site, Providencia

Sandoz Investigational Site, Santiago

Sandoz Investigational Site, Viña del Mar

Sandoz Investigational Site, Batumi

Sandoz Investigational Site, Tbilisi

Sandoz Investigational Site, Chemnitz

Sandoz Investigational Site, Düsseldorf

Sandoz Investigational Site, Giessen

Sandoz Investigational Site, Athens

Sandoz Investigational Site, Thessaloniki

Sandoz Investigational Site, Bari

Sandoz Investigational Site, Meldola

Sandoz Investigational Site, Pisa

Sandoz Investigational Site, Ravenna

Sandoz Investigational Site, Roma

Sandoz Investigational Site, Rozzano

Sandoz Investigational Site, Siena

Sandoz Investigational Site, Turin

Sandoz Investigational Site, Kaunas

Sandoz Investigational Site, Vilnius

Sandoz Investigational Site, Johor Bahru

Sandoz Investigational Site, Kuala Lumpur

Sandoz Investigational Site, Pulau Pinang

Sandoz Investigational Site, Putrajaya

Sandoz Investigational Site, Bacolod

Sandoz Investigational Site, Quezon City

Sandoz Investigational Site, Bydgoszcz

Sandoz Investigational Site, Poznan

Sandoz Investigational Site, Warsaw

Sandoz Investigational Site, Almada

Sandoz Investigational Site, Lisbon

Sandoz Investigational Site, Porto

Sandoz Investigational Site, Bucharest

Sandoz Investigational Site, Cluj-Napoca

Sandoz Investigational Site, Craiova

Sandoz Investigational Site, Busan

Sandoz Investigational Site, Daegu

Sandoz Investigational Site, Daejeon

Sandoz Investigational Site, Seoul

Sandoz Investigational Site, Suwon

Sandoz Investigational Site, Barcelona

Sandoz Investigational Site, Córdoba

Sandoz Investigational Site, Granada

Sandoz Investigational Site, Lugo

Sandoz Investigational Site, Madrid

Sandoz Investigational Site, Marbella

Sandoz Investigational Site, Málaga

Sandoz Investigational Site, Murcia

Sandoz Investigational Site, Oviedo

Sandoz Investigational Site, Santa Cruz de Tenerife

Sandoz Investigational Site, Santander

Sandoz Investigational Site, Santiago de Compostela

Sandoz Investigational Site, Valencia

Sandoz Investigational Site, Taichung

Sandoz Investigational Site, Tainan City

Sandoz Investigational Site, Taoyuan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY

NCT06587451 - Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy® | Biotech Hunter | Biotech Hunter