Spots Global Cancer Trial Database for Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
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Trial Identification
Brief Title: Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Official Title: Multicenter Open-label Study of the Efficacy, Pharmacokinetica and Safety of Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Study ID: NCT05783882
Conditions
Interventions
Study Description
Brief Summary: Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data. The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as: * selection criteria for subjects in the study, defining the population, * research centers, * procedures for evaluating effectiveness and safety, * permitted prior and concomitant therapy of the underlying disease.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Regional Clinical Oncology Dispensary" (SBHI AR ARCOD), Arkhangel'sk, , Russian Federation
State Budgetary Institution of Healthcare "Clinical Oncology Dispensary of Chelyabinsk Region" (SBIH CODCR), Cheliabinsk, , Russian Federation
N.N. Blokhin Russian Cancer Research Center, Moscow, , Russian Federation
State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD), Moscow, , Russian Federation
Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation, Research Department of the Innovative Methods of Therapeutic Oncology and Rehabilitation, Saint-Petersburg, , Russian Federation
Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation, Saint-Petersburg, , Russian Federation
Contact Details
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