Melanoma Stage IIIPhase 3NEO-MIMAJORNCT05751928
A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
A Phase 3 study testing BCD-217, anti-PD1 and Excision of the primary lesion in people with Melanoma Stage III and Melanoma (Skin), run by Biocad at 36 sites in 2 countries.
Trial summary
This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage III, Melanoma (Skin)
- What is being tested?
- BCD-217, anti-PD1 and Excision of the primary lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 5 Apr 2023to Jun 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol;
- Age ≥ 18 years at the time of signing the informed consent form;
- Histologically or cytologically confirmed (documented results of relevant studies are available) resectable stage IIIB/C/D skin melanoma;
- At least one clinically detectable lymph node accessible for biopsy and not more than three resectable in-transit metastases .
- Clinically detectable lymph nodes include:
- Palpable lymph nodes with pathologically confirmed melanoma
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- Non-palpable but enlarged (≥15 mm in smallest diameter, RECIST 1.1) lymph nodes with pathologically confirmed melanoma
- Subject's consent to a biopsy;
- Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ;
- ECOG score 0-1;
- Life expectancy of at least 5 years;
- Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the informed consent form throughout the study period and for 24 weeks after the administration of the last dose of the investigational therapy.
Who cannot join
- Ocular melanoma;
- Mucosal melanoma;
- Distant metastases;
- Impossibility of radical resection of the tumor, metastasis and/or involved lymph nodes;
- Presence of only in-transit transit/satellite metastases without confirmed involvement of lymph nodes;
- Prior therapy with checkpoint inhibitors (e.g. anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products);
Show all 41Show fewer
- Prior therapy with BRAF and MEK protein kinase inhibitors;
- Prior radiation therapy;
- Inability to determine BRAF status;
- Subjects with severe comorbidities, with life-threatening acute complications of the underlying disease at the time of signing the informed consent form;
- Current concomitant diseases at the time of screening, which increase the risk of severe adverse events during surgery and/or study therapy administration;
- stable angina, functional class III-IV;
- unstable angina or a history of myocardial infarction within less than 6 months prior to signing the informed consent form;
- moderate to severe cardiac failure (NYHA classes III and IV);
- uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) ;
- a history of atopic asthma , angioneurotic edema;
- respiratory failure (moderate to severe), grade 3 or 4 chronic obstructive pulmonary disease;
- any other concomitant diseases (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), which expose the subject to an unacceptable risk during surgery or study therapy;
- Known or suspected systemic autoimmune diseases (including, but not limited to, systemic lupus erythematosus, Crohn's disease, ulcerative colitis (UC), systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ;
- A history of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids;
- The need for glucocorticoid therapy (at >10mg/day prednisolone equivalent doses) or any other drugs with immunosuppressive effects within 6 months prior to randomization;
- Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study;
- Hematological abnormalities :
- neutrophils <1.5×109/L;
- platelets <100×109/L;
- hemoglobin <90 g/L;
- Renal impairment: creatinine ≥1.5×ULN;
- Hepatic impairment :
- Total bilirubin ≥1.3×ULN (except for subjects with Gilbert's syndrome, in whom bilirubin levels should not exceed 50 μmol/L);
- ALP, AST or ALT ≥1.5×ULN;
- Any surgery within less than 28 days prior to randomization in the study;
- History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ;
- Conditions limiting the subject's ability to comply with the Protocol requirements (in the Investigator's opinion );
- Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ;
- Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization;
- Active hepatitis B, active hepatitis C (confirmed by PCR), HIV-infection, currently or previously ;
- Impossibility to administer the investigational product intravenously;
- Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media);
- Hypersensitivity to any of the components of BCD-217, prolgolimab or pembrolizumab;
- A history of hypersensitivity to monoclonal antibody products;
- Pregnancy or breastfeeding.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
Russia32 sites
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",
Chelyabinsk, 454087
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Gatchina
State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Kazan'
State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"
Kemerovo
Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"
Kostroma, 156005
Clinical Oncologic Dispensary No. 1
Krasnodar, Krasnodar Kari, 350040
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"
Kuz'molovskiy
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow
Branch of Hadassah Medical LTD Limited Liability Company
Moscow
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow
Joint Stock Company "K31 City"
Moscow
JSC "Medsi Group"
Moscow
Moscow City Oncology Hospital No. 62
Moscow
State budgetary health care institution of the city of Moscow "City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow"
Moscow
Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"
Nizhny Novgorod, 603006
LLC "DobroMed"
Novosibirsk
State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region
Novosibirsk
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Obninsk
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Omsk
JSC "Modern Medical Technologies"
Saint Petersburg, 190013
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, 197758
City Hospital #40, Kurortny district
Saint Petersburg
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Saint Petersburg
Limited Liability Company "American Medical Clinic"
Saint Petersburg
Limited Liability Company "Oncological Research Center"
Saint Petersburg
Limited Liability Company "Strategic Medical Systems"
Saint Petersburg
N.N. Petrov National Medicine Research Center of oncology
Saint Petersburg
Private Medical Institution Evromedservis
Saint Petersburg
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Saransk
Clinical Oncologic Dispensary No. 2
Sochi, Krasnodar Territory, 354057
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Volgograd
Regional Clinical Oncology Hospital
Yaroslavl, Yaroslavl Oblast, 150054
Belarus4 sites
State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"
Lesnoy
Healthcare Institution "Minsk City Clinical Cancer Center"
Minsk, 220013
State Institution "Mogilev Regional Oncological Dispensary"
Mogilev
Healthcare Institution "Vitebsk Regional Clinical Oncology Center"
Vitebsk
About this study
Official title: A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma.
This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).
Read the detailed description
In both study groups, adjuvant therapy is possible until melanoma progresses to unresectable stage III-IV, unacceptable toxicity, withdrawal of ICF or the end of the therapy period (12 months).
In case of postoperative relapse of the disease, at the decision of the investigator and if the lesion is resectable, radical surgical treatment can be carried out (R0 - resection) in accordance with current clinical guidelines without withdrawing the patient from the study.
- Conditions
- Melanoma Stage III, Melanoma (Skin)
- Being tested
- BCD-217, anti-PD1, Excision of the primary lesion, Regional lymphadenectomy
- Keywords
- PD-1, CTLA-4, prolgolimab, nurulimab, immunotherapy, checkpoint inhibitors, CPI, programm death, cytotoxic T-lymphocyte-associated protein, Neoadjuvant Melanoma, Adjuvant Melanoma
- Medical subject headings
- Melanoma, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-217Biological
Also called nurulimab+prolgolimab
BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting
anti-PD1Biological
anti-PD1 agent in the adjuvant setting
Excision of the primary lesionProcedure or surgery
Excision of the primary lesion will be performed per standard of care.
Regional lymphadenectomyProcedure or surgery
Regional lymphadenectomy will be performed per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with pCR and pnCR (Group 1A) | Experimental | Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal.
Subjects with pathological complete (pCR) and near complete response (pnCR) (Group 1A): excision of the primary lesion (if not previously performed) without regional lymphadenectomy, followed by up to 12 months of anti-PD1 agent in the adjuvant setting. Receives: Biological: BCD-217; Biological: anti-PD1; Procedure: Excision of the primary lesion |
| Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B) | Experimental | Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal.
Subjects with a pathological partial response (pPR) or non-responders (pNR) to neoadjuvant therapy (Group 1B): excision of the primary lesion (if not performed earlier), regional lymphadenectomy, then up to 12 months of adjuvant therapy with anti-PD1 agent. Receives: Biological: BCD-217; Biological: anti-PD1; Procedure: Excision of the primary lesion; Procedure: Regional lymphadenectomy |
| Control Group (Group 2) | Active comparator | Subjects start treatment with excision of the primary lesion (if not previously performed), regional lymphadenectomy followed by adjuvant therapy with anti-PD1 agent (up to 12 months). This approach is considered the standard therapy for patients in the target population. Receives: Procedure: Excision of the primary lesion; Procedure: Regional lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival (EFS)
Measured: 24 months
Secondary outcomes (10)
overall survival (OS)
Measured: 24 months
distant metastases-free survival (DMFS)
Measured: 24 months
pathologic response rate (pRR)
Measured: 24 months
The proportion of subjects with treatment-related adverse events;
Measured: 24 months
The proportion of subjects experiencing any grade 3 or higher adverse events
Measured: 24 months
The proportion of subjects with SAEs
Measured: 24 months
The proportion of subjects with immune-related adverse events of any severity
Measured: 24 months
The proportion of subjects with severe immune-related adverse events (grade 3 or higher according to CTCAE v.5.0)
Measured: 24 months
The proportion of subjects requiring treatment discontinuation due to AEs
Measured: 24 months
The proportion of BAb and NAb positive subjects
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start5 Apr 2023
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Stage IIIStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751928
- Sponsor's protocol ID
- BCD-217-3
- Acronym
- NEO-MIMAJOR
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma.
- ClinicalTrials.gov ID
- NCT05751928
- Acronym / sponsor ID
- NEO-MIMAJOR / BCD-217-3
- Conditions
- Melanoma Stage III, Melanoma (Skin)
- Keywords
- PD-1, CTLA-4, prolgolimab, nurulimab, immunotherapy, checkpoint inhibitors, CPI, programm death
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 411 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Mar 2023 (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.
This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).
Detailed description
In both study groups, adjuvant therapy is possible until melanoma progresses to unresectable stage III-IV, unacceptable toxicity, withdrawal of ICF or the end of the therapy period (12 months).
In case of postoperative relapse of the disease, at the decision of the investigator and if the lesion is resectable, radical surgical treatment can be carried out (R0 - resection) in accordance with current clinical guidelines without withdrawing the patient from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with pCR and pnCR (Group 1A) | Experimental | Biological: BCD-217, Biological: anti-PD1, Procedure: Excision of the primary lesionSubjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with pathological complete (pCR) and near complete response (pnCR) (Group 1A): excision of the primary lesion (if not previously performed) without regional lymphadenectomy, followed by up to 12 months of anti-PD1 agent in the adjuvant setting. |
| Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B) | Experimental | Biological: BCD-217, Biological: anti-PD1, Procedure: Excision of the primary lesion, Procedure: Regional lymphadenectomySubjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with a pathological partial response (pPR) or non-responders (pNR) to neoadjuvant therapy (Group 1B): excision of the primary lesion (if not performed earlier), regional lymphadenectomy, then up to 12 months of adjuvant therapy with anti-PD1 agent. |
| Control Group (Group 2) | Active comparator | Procedure: Excision of the primary lesion, Procedure: Regional lymphadenectomySubjects start treatment with excision of the primary lesion (if not previously performed), regional lymphadenectomy followed by adjuvant therapy with anti-PD1 agent (up to 12 months). This approach is considered the standard therapy for patients in the target population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol;
- Age ≥ 18 years at the time of signing the informed consent form;
- Histologically or cytologically confirmed (documented results of relevant studies are available) resectable stage IIIB/C/D skin melanoma;
- At least one clinically detectable lymph node accessible for biopsy and not more than three resectable in-transit metastases .
- Subject's consent to a biopsy;
Key exclusion criteria (41 listed)
- Ocular melanoma;
- Mucosal melanoma;
- Distant metastases;
- Impossibility of radical resection of the tumor, metastasis and/or involved lymph nodes;
- Presence of only in-transit transit/satellite metastases without confirmed involvement of lymph nodes;
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 |
|---|---|---|
| BCD-217Also: nurulimab+prolgolimabBCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting | Biological | Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B), Subjects with pCR and pnCR (Group 1A) |
| anti-PD1anti-PD1 agent in the adjuvant setting | Biological | Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B), Subjects with pCR and pnCR (Group 1A) |
| Excision of the primary lesionExcision of the primary lesion will be performed per standard of care. | Procedure or surgery | Control Group (Group 2), Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B), Subjects with pCR and pnCR (Group 1A) |
| Regional lymphadenectomyRegional lymphadenectomy will be performed per standard of care. | Procedure or surgery | Control Group (Group 2), Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B) |
Primary outcome
event free survival (EFS)
Time frame: 24 months
10 secondary outcomes
overall survival (OS)
Time frame: 24 months
distant metastases-free survival (DMFS)
Time frame: 24 months
pathologic response rate (pRR)
Time frame: 24 months
The proportion of subjects with treatment-related adverse events;
Time frame: 24 months
The proportion of subjects experiencing any grade 3 or higher adverse events
Time frame: 24 months
The proportion of subjects with SAEs
Time frame: 24 months
The proportion of subjects with immune-related adverse events of any severity
Time frame: 24 months
The proportion of subjects with severe immune-related adverse events (grade 3 or higher according to CTCAE v.5.0)
Time frame: 24 months
The proportion of subjects requiring treatment discontinuation due to AEs
Time frame: 24 months
The proportion of BAb and NAb positive subjects
Time frame: 24 months
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 8 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-217, anti-PD1 and Excision of the primary lesion in people with Melanoma Stage III and Melanoma (Skin), run by Biocad at 36 sites in 2 countries.
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 12 inclusion and 41 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Russia, Belarus. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event free survival (EFS) (time frame: 24 months). 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 8 Jul 2025.