NCT05732805

Active, not recruiting

Phase 3

A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

Biocad63 sites in 3 countries270 target enrollmentAugust 2, 2022

ConditionsMelanoma Melanoma (Skin)Melanoma Stage III Melanoma Stage IV Melanoma Unresectable Melanoma Metastatic Melanoma Advanced

InterventionsBCD-217 BCD-100 Placebo

DrugsBCD-217 BCD-100 Placebo

Overview

Phase: Phase 3
Intervention: BCD-217
Conditions: Melanoma
Sponsor: Biocad
Enrollment: 270
Locations: 63
Primary Endpoint: Progression-free survival
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

Detailed Description

This study is designed as a phase III, randomized, double-blind, placebo-controlled study. After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups: * BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group) * Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)

Registry

clinicaltrials.gov

Start Date

August 2, 2022

End Date

July 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biocad

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol;
•Age ≥18 years at the time of signing the informed consent form;
•Histologically confirmed melanoma (with available documented evidence of relevant investigations);
•Untreated unresectable stage III melanoma or untreated metastatic (stage IV) melanoma;
•Available blocks for histological examination and/or the subject's consent to undergo biopsy ;
•Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status at a central laboratory;
•ECOG score 0-1;
•Life expectancy of at least 12 weeks ;
•Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria , confirmed by central independent reviewer;
•In subjects of childbearing potential, willingness to use reliable contraceptive measures throughout the study, from the signing of the informed consent form and for additional 24 weeks after the administration of the last dose of the investigational product.

Exclusion Criteria

•Indications for radical (surgical, radiation) therapy;
•A history of previous systemic antitumor therapy for unresectable or metastatic melanoma ;
•Prior therapy with checkpoint inhibitors (e.g., anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products);
•Prior therapy with BRAF and MEK protein kinase inhibitors;
•Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study;
•Ocular melanoma;
•Mucosal melanoma;
•CNS metastases;
•Impossibility to determine PD-L1 status and/or BRAF status;
•Subjects with severe comorbidities, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention , pulmonary lymphangitis, bleeding, or organ perforation) at the time of signing the informed consent form;

Arms & Interventions

BCD-217 (nurulimab + prolgolimab)

BCD-217 followed by prolgolimab 1 mg/kg monotherapy.

Intervention: BCD-217

BCD-217 (nurulimab + prolgolimab)

BCD-217 followed by prolgolimab 1 mg/kg monotherapy.

Intervention: BCD-100

BCD-217 (nurulimab + prolgolimab)

BCD-217 followed by prolgolimab 1 mg/kg monotherapy.

Intervention: Placebo

BCD-100 (prolgolimab)

Prolgolimab monotherapy.

Intervention: BCD-100

BCD-100 (prolgolimab)

Prolgolimab monotherapy.

Intervention: Placebo

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: 24 months

Secondary Outcomes

The proportion of subjects experiencing any grade 3 or higher adverse events(24 months)
The proportion of subjects with SAEs(24 months)
The proportion of subjects with immune-related adverse events of any severity(24 months)
The proportion of BAb and NAb positive subjects(24 months)
Duration of response(24 months)
Overall survival(24 months)
Time to response(24 months)
The proportion of subjects experiencing adverse events related to study therapy(24 months)
The proportion of subjects requiring treatment discontinuation due to AEs(24 months)
Ctrough (plasma concentration of anti-PD-1/CTLA-4 monoclonal antibody measured at the end of the dosing interval before the next dose)(24 months)
Overall response rate (partial response + complete response rate)(24 months)
Disease control rate (stable disease + partial response + complete response rate)(24 months)
The proportion of subjects with severe immune-related adverse events(24 months)