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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)
• Intervention / Treatment: Biological: Bmab1800; Biological: US-Licensed Keytruda

Detailed Description

This is a randomized, double-blind, two-arm, parallel-group, multicenter Phase 1 study conducted in adult patients with Stage IIB, IIC, or Stage III melanoma following complete surgical resection. Approximately 138 patients will be randomized in 1:1 ratio to receive either Bmab1800 or Keytruda.

Study treatment will be administered intravenously at a dose of 200 mg every 3 weeks till Week 21. Post which the patient will continue through Week 21, with continuation through Week 24. At Week 24, following completion of all pre dose assessments, patients who were initially randomized to the pembrolizumab arm and who are eligible to continue treatment will transition to the Bmab1800 arm and receive Bmab1800 during an open label treatment period. These patients will continue to receive Bmab1800 through Week 48 (end of treatment for the open label treatment period [EOT OL TP]), with end of study at Week 51 (EOS OL TP), ensuring that all patients receive pembrolizumab equivalent therapy in accordance with recommended treatment guidelines.

The primary objective is to demonstrate PK equivalence based on AUC0-21 and AUC over a dosage interval at steady-state (AUCτ during Cycle 7; Week 18 to Week 21) PK parameters. Safety and immunogenicity will be evaluated through Week 24. Additional safety follow-up during an open-label treatment period through Week 51.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• All patients must have disease-free status (ie, no evidence of locoregional recurrence or distant metastasis); no clinical evidence of brain metastases.

Exclusion Criteria:

• 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.
• Prior therapy with anti-PD-1 (including pembrolizumab), anti PD-L1, anti PD L2, anti CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody) or agents that target interleukin-2 (IL-2) pathway any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.
• Requirement for systemic treatment corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
• 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.
• Prior therapy with anti-PD-1 (including pembrolizumab), anti PD-L1, anti PD L2, anti CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody) or agents that target interleukin-2 (IL-2) pathway any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.
• Requirement for systemic treatment corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
• Receipt of treatment directed against the resected melanoma (eg, chemotherapy, targeted agents, biotherapy, or limb perfusion) administered after the complete resection.
• History of allergy or hypersensitivity to pembrolizumab or its excipients.
• History of severe hypersensitivity reaction (Grade ≥3) to any monoclonal antibody.
• Received prior anticancer therapy including mAb, chemotherapy, or an investigational agent or device within 5 half-lives before first dose of study intervention or not recovered (ie, > Grade 1 or at baseline) from AEs due to previously administered agents at screening and before randomization.
• Patients with ≤ Grade 2 neuropathy are an exception and may qualify for the study.
• Received a live vaccine within 30 days prior to the first dose of study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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
Active Comparator: US-Licensed Keytruda; 200 mg Q3W, intravenous infusion, over 24 weeks; Double-blind period through Week 24	Biological: US-Licensed Keytruda; 200 mg Q3W, intravenous infusion, over 24 weeks; Double-blind period through Week 24

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Curve from Time 0 to 21 Days (AUC₀-₂₁days)	Assessed to compare pharmacokinetics of Bmab1800 and Keytruda®	Week 0 to Week 3
Time Curve Over the Dosing Interval at Steady State (AUCτ)	Cycle 7 (Week 18 to Week 21)	Assessed to demonstrate steady-state PK equivalence

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax		From first dose through Week 24 (DB-TP)
tmax		From first dose through Week 24 (DB-TP)
Cmax,ss		From first dose through Week 24 (DB-TP)
tmax,ss		From first dose through Week 24 (DB-TP)
Ctrough		From first dose through Week 24 (DB-TP)
Incidence and severity of adverse events and serious adverse events	Assessed by incidence and severity of adverse events and serious adverse events	From first dose through Week 24 (DB-TP)
Immunogenicity	Assessed by incidence of anti-drug antibodies	From first dose through Week 24 (DB-TP)

Collaborators and Investigators

• Sponsor: Biocon Biologics UK PLC

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): June 21, 2028

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pembrolizumab; Melanoma; Biosimilar; Adjuvant Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: BIO-BM1800-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No