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RECRUITING
NCT07581509
PHASE1

Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma

Sponsor: Biocon Biologics UK PLC

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the pharmacokinetic (PK) equivalence of Bmab1800 as compared with reference product Keytruda® in a randomized, double-blind, two-arm, parallel comparative, multi-center study in patients with resected melanoma (Stage IIB, or Stage IIC, or Stage III) as an adjuvant treatment. This study also compares the safety and immunogenicity of Bmab1800 and Keytruda.

Official title: A Randomized, Double-blind, Two-arm, Parallel Comparative Multi-center Study to Assess and Compare the Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2026-06-29

Completion Date

2028-06-21

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Bmab1800

* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24; eligible patients may continue in open-label period through Week 48

BIOLOGICAL

US-Licensed Keytruda

* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24

Locations (1)

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil