Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

2026-08

Completion Date

2028-02-16

Last Updated

2026-08-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Bmab1700

Intravenous infusion.

DRUG

Opdivo

Intravenous infusion.

Locations (48)

Biocon Investigational Site

Bento Gonçalves, Brazil

Biocon Investigational Site

Ijuí, Brazil

Biocon Investigational Site

Pará, Brazil

Biocon Investigational Site

Porto Alegre, Brazil

Biocon Investigational Site

Rio de Janeiro, Brazil

Biocon Investigational Site 1

Santa Catarina, Brazil

Biocon Investigational Site 2

Santa Catarina, Brazil

Biocon Investigational Site

Santa Catarina, Brazil

Biocon Investigational Site 1

São Paulo, Brazil

Biocon Investigational Site 2

São Paulo, Brazil

Biocon Investigational Site

São Paulo, Brazil

Biocon Investigational Site

Providencia, Chile

Biocon Investigational Site

Recoleta, Chile

Biocon Investigational Site 1

Santiago, Chile

Biocon Investigational Site

Santiago, Chile

Biocon Investigational Site

Batumi, Georgia

Biocon Investigational Site

Kutaisi, Georgia

Biocon Investigational Site 1

Tbilisi, Georgia

Biocon Investigational Site 2

Tbilisi, Georgia

Biocon Investigational Site 3

Tbilisi, Georgia

Biocon Investigational Site 4

Tbilisi, Georgia

Biocon Investigational Site 5

Tbilisi, Georgia

Biocon Investigational Site

Tbilisi, Georgia

Biocon Investigational Site

Chisinau, Moldova

Biocon Investigational Site

Bucharest, Romania

Site 26

Cluj-Napoca, Romania

Biocon Investigational Site

Craiova, Romania

Biocon Investigational Site 1

Belgrade, Serbia

Biocon Investigational Site

Belgrade, Serbia

Biocon Investigational Site

Kamenitz, Serbia

Biocon Investigational Site

Kragujevac, Serbia

Biocon Investigational Site

Niš, Serbia

Biocon Investigational Site

George, South Africa

Biocon Investigational Site 1

Johannesburg, South Africa

Biocon Investigational Site

Johannesburg, South Africa

Biocon Investigational Site

Port Elizabeth, South Africa

Biocon Investigational Site 1

Barcelona, Spain

Biocon Investigational Site

Barcelona, Spain

Biocon Investigational Site

Madrid, Spain

Biocon Investigational Site

Murcia, Spain

Biocon Investigational Site

Sabadell, Spain

Biocon Investigational Site 1

Seville, Spain

Biocon Investigational Site

Seville, Spain

Biocon Investigational Site

Ankara, Turkey (Türkiye)

Biocon Investigational Site

Bornova, Turkey (Türkiye)

Biocon Investigational Site

Konak, Turkey (Türkiye)

Biocon Investigational Site

Ivano-Frankivsk, Ukraine

Biocon Investigational Site

Kyiv, Ukraine