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

NCT07581509 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BIO-BM1800-104
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)

Keywords

Pembrolizumab; Melanoma; Biosimilar; Adjuvant Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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)

Study Arms (2)

Bmab1800

EXPERIMENTAL

* 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

US-Licensed Keytruda

ACTIVE COMPARATOR

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

Biological: US-Licensed Keytruda

Interventions

US-Licensed Keytruda BIOLOGICAL

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

US-Licensed Keytruda

Bmab1800 BIOLOGICAL

* 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

Bmab1800

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocon Biologics UK PLC: lead

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): June 21, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share