Clinical trial 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®
Official title: A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.


Eligibility criteria: Inclusion Criteria

* Male or female participants must be 18 years or older.
* Histologically confirmed melanoma.
* Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.
* Sexually active participants must agree to use effective contraception.

Exclusion Criteria

* Active brain or leptomeningeal metastases unless stable for 8 weeks.
* Ocular melanoma.
* Prior active malignancy within the last year untreated or still requiring treatment.
* Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.
* Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.

Primary outcomes:
measure: Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
timeFrame: Days 1 to 22
measure: Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU
timeFrame: Days 64 to 85
measure: Demonstrate efficacy similarity for Best overall response (BOR) between JPB898 and Opdivo-US/-EU defined as the best overall response based on blinded central tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
timeFrame: BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sandoz Investigational Site
city: Providencia
country: Chile
facility: Sandoz Investigational Site
city: Santiago
country: Chile
facility: Sandoz Investigational Site
city: Vina del Mar
country: Chile
facility: Sandoz Investigational Site
city: Batumi
country: Georgia
facility: Sandoz Investigational Site
city: Tbilisi
country: Georgia
facility: Sandoz Investigational Site
city: Chemnitz
country: Germany
facility: Sandoz Investigational Site
city: Athens
country: Greece
facility: Sandoz Investigational Site
city: Thessaloniki
country: Greece
facility: Sandoz Investigational Site
city: Bari
country: Italy
facility: Sandoz Investigational Site
city: Meldola
country: Italy
facility: Sandoz Investigational Site
city: Pisa
country: Italy
facility: Sandoz Investigational Site
city: Ravenna
country: Italy
facility: Sandoz Investigational Site
city: Roma
country: Italy
facility: Sandoz Investigational Site
city: Rozzano
country: Italy
facility: Sandoz Investigational Site
city: Siena
country: Italy
facility: Sandoz Investigational Site
city: Turin
country: Italy
facility: Sandoz Investigational Site
city: Busan
country: Korea, Republic of
facility: Sandoz Investigational Site
city: Daegu
country: Korea, Republic of
facility: Sandoz Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Sandoz Investigational Site
city: Seoul
country: Korea, Republic of
facility: Sandoz Investigational Site
city: Suwon
country: Korea, Republic of
facility: Sandoz Investigational Site
city: Kaunas
country: Lithuania
facility: Sandoz Investigational Site
city: Vilnius
country: Lithuania
facility: Sandoz Investigational Site
city: Johor Bahru
country: Malaysia
facility: Sandoz Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Sandoz Investigational Site
city: Pulau Pinang
country: Malaysia
facility: Sandoz Investigational Site
city: Putrajaya
country: Malaysia
facility: Sandoz Investigational Site
city: Bacolod
country: Philippines
facility: Sandoz Investigational Site
city: Poznan
country: Poland
facility: Sandoz Investigational Site
city: Warsaw
country: Poland
facility: Sandoz Investigational Site
city: Almada
country: Portugal
facility: Sandoz Investigational Site
city: Lisbon
country: Portugal
facility: Sandoz Investigational Site
city: Bucharest
country: Romania
facility: Sandoz Investigational Site
city: Cluj-Napoca
country: Romania
facility: Sandoz Investigational Site
city: Craiova
country: Romania
facility: Sandoz Investigational Site
city: Barcelona
country: Spain
facility: Sandoz Investigational Site
city: Cordoba
country: Spain
facility: Sandoz Investigational Site
city: Lugo
country: Spain
facility: Sandoz Investigational Site
city: Madrid
country: Spain
facility: Sandoz Investigational Site
city: Malaga
country: Spain
facility: Sandoz Investigational Site
city: Marbella
country: Spain
facility: Sandoz Investigational Site
city: Murcia
country: Spain
facility: Sandoz Investigational Site
city: Oviedo
country: Spain
facility: Sandoz Investigational Site
city: Santa Cruz De Tenerife
country: Spain
facility: Sandoz Investigational Site
city: Santander
country: Spain
facility: Sandoz Investigational Site
city: Santiago De Compostela
country: Spain
facility: Sandoz Investigational Site
city: Valencia
country: Spain
facility: Sandoz Investigational Site
city: Taichung City
country: Taiwan
facility: Sandoz Investigational Site
city: Taoyuan City
country: Taiwan
facility: Sandoz Investigational Site
Study officials:
References: