Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)Phase 1NCT07581509
Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma
A Phase 1 study testing Bmab1800 and US-Licensed Keytruda in people with Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings), run by Biocon Biologics UK PLC at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)
- What is being tested?
- Bmab1800 and US-Licensed Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jun 2026to 21 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Dr.Fernanda Menezes Hassan, +551733216637, fernandahassan@hotmail.com
Mariana Regina da Cunha Bars, mariana.cunha@hcancerbarretos.com.br
About this study
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
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.
Read the 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.
- Being tested
- Bmab1800, US-Licensed Keytruda
- Keywords
- Pembrolizumab, Melanoma, Biosimilar, Adjuvant Therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmab1800Biological
- 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 KeytrudaBiological
- 200 mg Q3W, intravenous infusion, over 24 weeks
- Double-blind period through Week 24
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Bmab1800 |
| US-Licensed Keytruda | Active comparator | * 200 mg Q3W, intravenous infusion, over 24 weeks
* Double-blind period through Week 24 Receives: Biological: US-Licensed Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Curve from Time 0 to 21 Days (AUC₀-₂₁days)
Assessed to compare pharmacokinetics of Bmab1800 and Keytruda®
Measured: Week 0 to Week 3
Time Curve Over the Dosing Interval at Steady State (AUCτ)
Cycle 7 (Week 18 to Week 21)
Measured: Assessed to demonstrate steady-state PK equivalence
Secondary outcomes (7)
Cmax
Measured: From first dose through Week 24 (DB-TP)
tmax
Measured: From first dose through Week 24 (DB-TP)
Cmax,ss
Measured: From first dose through Week 24 (DB-TP)
tmax,ss
Measured: From first dose through Week 24 (DB-TP)
Ctrough
Measured: 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
Measured: From first dose through Week 24 (DB-TP)
Immunogenicity
Assessed by incidence of anti-drug antibodies
Measured: From first dose through Week 24 (DB-TP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start29 Jun 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion21 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581509
- Sponsor's protocol ID
- BIO-BM1800-104
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07581509
- Acronym / sponsor ID
- BIO-BM1800-104
- Keywords
- Pembrolizumab, Melanoma, Biosimilar, Adjuvant Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Biocon Biologics UK PLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 21 Jun 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bmab1800 | Experimental | 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 |
| US-Licensed Keytruda | Active comparator | Biological: US-Licensed Keytruda* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| US-Licensed Keytruda* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24 | Biological | US-Licensed Keytruda |
Primary outcome
Time Curve from Time 0 to 21 Days (AUC₀-₂₁days)
Time frame: Week 0 to Week 3
Assessed to compare pharmacokinetics of Bmab1800 and Keytruda®
Time Curve Over the Dosing Interval at Steady State (AUCτ)
Time frame: Assessed to demonstrate steady-state PK equivalence
Cycle 7 (Week 18 to Week 21)
7 secondary outcomes
Cmax
Time frame: From first dose through Week 24 (DB-TP)
tmax
Time frame: From first dose through Week 24 (DB-TP)
Cmax,ss
Time frame: From first dose through Week 24 (DB-TP)
tmax,ss
Time frame: From first dose through Week 24 (DB-TP)
Ctrough
Time frame: From first dose through Week 24 (DB-TP)
Incidence and severity of adverse events and serious adverse events
Time frame: From first dose through Week 24 (DB-TP)
Immunogenicity
Time frame: From first dose through Week 24 (DB-TP)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bmab1800 and US-Licensed Keytruda in people with Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings), run by Biocon Biologics UK PLC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Curve from Time 0 to 21 Days (AUC₀-₂₁days) (time frame: Week 0 to Week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.