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NOT YET RECRUITING
NCT07476326
PHASE1

Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma

Sponsor: Biocon Biologics UK PLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.

Official title: A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB/C, Stage III, or Stage IV Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-06-01

Completion Date

2028-02-16

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Bmab1700

Intravenous infusion.

DRUG

Opdivo

Intravenous infusion.

Locations (26)

High Technology Hospital Medcenter

Batumi, Georgia

JSC Vian

Kutaisi, Georgia

Institute of Clinical Oncology - Lubliana Street

Tbilisi, Georgia

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

LTD New Hospitals

Tbilisi, Georgia

Todua Clinic

Tbilisi, Georgia

Centrul de Oncologie Sfantu Nectarie

Craiova, Romania

Institute for Oncology and Radiology of Serbia

Belgrade, Serbia

Military Medical Academy

Belgrade, Serbia

Oncology Institute of Vojvodina

Kamenitz, Serbia

University Clinical Center Kragujevac, Clinic for Oncology

Kragujevac, Serbia

University Clinical Center Nis, Clinic for Oncology/

Niš, Serbia

Excellentis Clinical Trial Consultants

George, South Africa

The Medical Oncology Center of Rosebank

Johannesburg, South Africa

WITS Clinical Research - Wits Donald Gordon Medical Centre

Johannesburg, South Africa

Phoenix Pharma Pty Ltd

Port Elizabeth, South Africa

Hospital Universitario Vall d\'Hebron

Barcelona, Spain

Instituto Oncológico Dr. Rosell (IOR) - Hospital Universitari Quirón Dexeus

Barcelona, Spain

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Virgen de Arrixaca

Murcia, Spain

Institut d'Investigació iInnovació Parc Taulí

Sabadell, Spain

Hospital Universitario Virgen del Rocío (HUVR)

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Universities, 1604. Cadde No 9 Ankara, Ankara 06800 Türkiye, Ankara Billkent Şehir Hastanesi

Ankara, Turkey (Türkiye)

Ege University Tulay Aktas Oncology Hospital

Bornova, Turkey (Türkiye)

Dokuz Eylul University Medical Oncology Hospital Dokuz Eylül Üniverstesi Medikal Onkolji Hastanesi

Konak, Turkey (Türkiye)