Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBiocon Biologics UK PLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients aged ≥18 years (or legal adult age per local regulations)
ECOG Performance Status of 0 or 1 at screening and prior to randomization.
Histologically confirmed melanoma that is completely surgically resected with negative margins (per local standard), classified as: Stage IIB, IIC, or Stage III melanoma per AJCC Cancer Staging Manual, 8th edition.
Patients must have undergone definitive melanoma resection ≥28 days prior to signing informed consent, and randomization must occur within 12 weeks after surgery.
Disqualifiers
History of ocular/uveal and mucosal melanoma.
Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment
Active, known, or suspected autoimmune disease that has required systemic treatment in past 2 years.
Prior malignancy active within the previous 3 years, except for early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Bmab1800
Biological/Vaccine* 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
US-Licensed Keytruda
Biological/Vaccine* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Bmab1800Experimental treatment 1 intervention
Group B: US-Licensed KeytrudaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time Curve from Time 0 to 21 Days (AUC₀-₂₁days)
Assessed to compare pharmacokinetics of Bmab1800 and Keytruda®
Time frame
Week 0 to Week 32
Time Curve Over the Dosing Interval at Steady State (AUCτ)
Cycle 7 (Week 18 to Week 21)
Time frame
Assessed to demonstrate steady-state PK equivalenceSecondary outcomes
1
Cmax
Time frame
From first dose through Week 24 (DB-TP)2
tmax
Time frame
From first dose through Week 24 (DB-TP)3
Cmax,ss
Time frame
From first dose through Week 24 (DB-TP)4
tmax,ss
Time frame
From first dose through Week 24 (DB-TP)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov