New keytruda copycat tested in melanoma patients after surgery
NCT ID NCT07581509
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called Bmab1800 to see if it works like the approved drug Keytruda in people with stage IIB, IIC, or III melanoma after their tumor has been removed by surgery. About 138 adults will get either Bmab1800 or Keytruda, and researchers will compare how the drug moves through the body, its safety, and whether the body fights it. The goal is to see if Bmab1800 is a safe and effective alternative to Keytruda for preventing melanoma from coming back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.