An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients With Unresectable/Metastatic Melanoma.

Biocad9 sites in 1 country126 target enrollmentAugust 31, 2017

ConditionsMelanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Melanoma
Sponsor: Biocad
Enrollment: 126
Locations: 9
Primary Endpoint: Overall response rate
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with Unresectable/Metastatic Melanoma.

Detailed Description

This trial has been designed as an international multicenter open-label Phase II trial. The trial aims to investigate the efficacy, pharmacokinetics, safety, and immunogenicity of two dosage regimens of BCD-100 (JSC BIOCAD, Russia) as monotherapy in patients with unresectable/metastatic melanoma. According to the design, the trial will include two arms of patients. Each of the trial arms will receive repeated doses of the test drug as monotherapy; BCD-100 will be administered using one of the following dosage regimens established in a Phase I trial: * Monotherapy, BCD-100 1 mg/kg Q2W (IV infusion over 60 minutes; if a 60-minute infusion is tolerated well, all following doses can be administered over 30 minutes); * Monotherapy, BCD-100 3 mg/kg Q3W (IV infusion over 60 minutes; if a 60-minute infusion is tolerated well, all following doses can be administered over 30 minutes).

Registry

clinicaltrials.gov

Start Date

August 31, 2017

End Date

January 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biocad

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
•Age: 18 years and older at the signing of the informed consent;
•Histologically verified (documented) unresectable/metastatic melanoma;
•Newly diagnosed advanced/metastatic melanoma or progressive disease during (or after) systemic chemotherapy ;
•Available tissue blocks for histological examination or patient's agreement to give biopsy specimens for PD-L1 expression status ;
•ECOG performance status of 0 or 1;
•LDH less than or equal to 2×upper limit of normal;
•At least one RESICT 1.1-defined measurable target lesion confirmed by an independent review;
•All prior treatment-related toxicities/surgery-related adverse events must be less than or equal to Grade 2 according to CTCAE 4.03, except for chronic/permanent damage caused by an AE that does not affect the safety profile of the investigational therapy (e.g., alopecia);
•Adequate organ system function ;

Exclusion Criteria

•Evidence of severe or concomitant diseases/life-threatening complications of the main condition (e.g., massive pleural, pericardial, or peritoneal effusion that requires medical intervention , pulmonary lymphangitis) at the signing of the informed consent;
•Subjects with progressive/symptomatic brain metastases (e.g., brain edema, spinal cord compression) or brain metastases that need therapy with corticosteroids and/or anticonvulsants ;
•Any concomitant disease observed at the screening that increases the risk of adverse events during the investigational therapy:
•Grade III-IV stable angina, unstable angina, or a history of myocardial infarction within 6 months prior to signing the informed consent;
•Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
•Severe, resistant hypertension;
•History of atopic asthma, angioedema;
•Moderate to severe respiratory failure, Grade 3 to 4 chronic obstructive pulmonary disease;
•Any other concomitant condition (e.g., metabolism, blood, hepatic, renal, pulmonary, neurological, endocrine, cardiac, infectious, or gastrointestinal disorder) that constitutes an unacceptable risk to the patient's health during the investigational therapy;
•Systemic autoimmune diseases (including but not limited to SLE, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ;