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

NCT06587451 | Terminated Phase 3 FDA Drug

• 1 other identifier: CJPB898A12301
• Study Type: interventional
• Target: 52
• Locations: 11 countries
• Sites: 22

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (3)

• Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU

  Area under the serum concentration-time curve measured from the time of dosing of the first dose to the second dose (AUCtrunc) after the first dose

  Days 1 to 22

• Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU

  Area under the serum concentration-time curve measured from the time of dosing to the last measurable serum concentration in the dosing interval, tau (AUCtau) after the fourth dose

  Days 64 to 85

• 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

  The assessment of response for the primary efficacy is based on tumor response data as per blinded independent central review and according to RECIST 1.1

  BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks

Study Arms (3)

JPB898

EXPERIMENTAL

Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.

Drug: JPB898 (Induction and Maintenance); Drug: Yervoy-EU (Induction)

Opdivo-EU

ACTIVE COMPARATOR

Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.

Drug: Opdivo-EU (Induction); Drug: Yervoy-EU (Induction); Drug: Opdivo-EU (Maintenance)

Opdivo-US

ACTIVE COMPARATOR

Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.

Drug: Opdivo-US (Induction); Drug: Yervoy-EU (Induction); Drug: Opdivo-EU (Maintenance)

Interventions

Opdivo-EU (Induction) DRUG

Induction: Intravenous (IV)

Opdivo-EU

Opdivo-US (Induction) DRUG

Induction: Intravenous (IV)

Opdivo-US

Yervoy-EU (Induction) DRUG

Induction: Intravenous (IV)

JPB898; Opdivo-EU; Opdivo-US

Opdivo-EU (Maintenance) DRUG

Maintenance: Intravenous (IV)

Opdivo-EU; Opdivo-US

JPB898 (Induction and Maintenance) DRUG

Induction and Maintenance: Intravenous (IV)

JPB898

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (22)

Sandoz Investigational Site 1

Santiago, Chile

Location

Sandoz Investigational Site

Santiago, Chile

Location

Sandoz Investigational Site 2

Tbilisi, Georgia

Location

Sandoz Investigational Site

Athens, Greece

Location

Sandoz Investigational Site

Thessaloniki, Greece

Location

Sandoz Investigational Site

Pisa, Italy

Location

Sandoz Investigational Site

Vilnius, Lithuania

Location

Sandoz Investigational Site

Kuala Lumpur, Malaysia

Location

Sandoz Investigational Site

Pulau Pinang, Malaysia

Location

Sandoz Investigational Site

Putrajaya, Malaysia

Location

Sandoz Investigational Site

Bacolod, Philippines

Location

Sandoz Investigational Site

Warsaw, Poland

Location

Sandoz Investigational Site

Lisbon, Portugal

Location

Sandoz Investigational Site 1

Busan, South Korea

Location

Sandoz Investigational Site

Daejeon, South Korea

Location

Sandoz Investigational Site 2

Seoul, South Korea

Location

Sandoz Investigational Site 2

Madrid, Spain

Location

Sandoz Investigational Site

Málaga, Spain

Location

Sandoz Investigational Site

Oviedo, Spain

Location

Sandoz Investigational Site

Santander, Spain

Location

Sandoz Investigational Site

Santiago de Compostela, Spain

Location

Sandoz Investigational Site 2

Valencia, Spain

Location

MeSH Terms

Conditions

Melanoma

Interventions

Neoadjuvant Therapy; Maintenance

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: December 19, 2024
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3); ES (6); MY (3); PL (1); IT (1); PT (1); GR (2); CL (2); GE (1); PH (1); LI (1)