Строяковский Даниил Львович

BCD-263-2^{ClinicalTrials.gov}

Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® As Monotherapy in Subjects with Advanced Melanoma of the Skin

Статус:	Recruiting
Фаза:	Phase 3
Начало:	21 марта 2024 г.
Окончание:	1 марта 2027 г.
Описание:	The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin.
	смотреть на ClinicalTrials.gov

BCD-263-1^{ClinicalTrials.gov}

A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

^ГРЛС Двойное слепое рандомизированное клиническое исследование фармакокинетики и безопасности препарата BCD-263 и препарата Опдиво® в монотерапии у субъектов с распространенной меланомой кожи

Статус:	Recruiting
Фаза:	Phase 1
Начало:	29 мая 2023 г.
Окончание:	1 января 2027 г.
Описание:	The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.
	смотреть на ClinicalTrials.gov

BCD-217-3^{ClinicalTrials.gov}

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

Статус:	Recruiting
Фаза:	Phase 3
Начало:	1 марта 2023 г.
Окончание:	1 июня 2027 г.
Описание:	This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).
	смотреть на ClinicalTrials.gov

BCD-217-2^{ClinicalTrials.gov}

A Clinical Study 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

Статус:	Recruiting
Фаза:	Phase 3
Начало:	2 августа 2022 г.
Окончание:	1 апреля 2025 г.
Описание:	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.
	смотреть на ClinicalTrials.gov

BCD-100-5^{ClinicalTrials.gov}

Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)

Статус:	Recruiting
Фаза:	Phase 3
Начало:	1 октября 2019 г.
Окончание:	1 декабря 2024 г.
Описание:	This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab
	смотреть на ClinicalTrials.gov

BCD-100-3^{ClinicalTrials.gov}

Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC

Статус:	Unknown status
Фаза:	Phase 3
Начало:	1 июня 2019 г.
Окончание:	1 декабря 2023 г.
Описание:	This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with pemetrexed+cisplatin/carboplatin in subjects with previously untreated metastatic non-squamous NSCLC. The main hypothesis of the study is that BCD-100 in combination with chemotherapy prolongs OS compared to placebo with chemotherapy.
	смотреть на ClinicalTrials.gov

BCD-100-4/CAESURA^{ClinicalTrials.gov}

Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA)

^ГРЛС Многоцентровое открытое несравнительное исследование эффективности и безопасности препарата BCD-100 (ЗАО «БИОКАД», Россия) в комбинации с платиносодержащей химиотерапией и бевацизумабом в терапии первой линии у пациенток с рецидивирующим/персистирующим либо метастатическим раком шейки матки

Статус:	Unknown status
Фаза:	Phase 2
Начало:	25 декабря 2018 г.
Окончание:	7 июля 2020 г.
Описание:	This is a multicenter, open-label, single-arm study of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) in combination with platinum-based chemotherapy and bevacizumab as first-line treatment in patients with recurrent/persistent or metastatic cervical cancer.
	смотреть на ClinicalTrials.gov

BCD-263-2 ClinicalTrials.gov