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

Phase 3TerminatedNCT06587451

Sandoz52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Melanoma

Interventions

JPB898 (Induction and Maintenance)DRUG

Induction and Maintenance: Intravenous (IV)

Opdivo-EU (Induction)DRUG

Induction: Intravenous (IV)

Opdivo-US (Induction)DRUG

Induction: Intravenous (IV)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Sandoz Investigational Site 1

Santiago, Chile

Sandoz Investigational Site

Santiago, Chile

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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