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Neoadjuvant therapy for resectable stage III skin melanoma

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.

Phase 3 Interventional Biocad · NCT05751928

This study is testing a new combination treatment for patients with stage III skin melanoma to see if it helps them stay healthy after surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment410 (estimated)
Ages18 Years and up
SexAll
SponsorBiocad Industry-sponsored
Drugs / interventionsprolgolimab, pembrolizumab, radiation
Locations36 sites (Lesnoy and 35 other locations)
Trial IDNCT05751928 on ClinicalTrials.gov

What this trial studies

This open-label, randomized, comparative phase III study evaluates the effectiveness of BCD-217, a combination of nurulimab and prolgolimab, in patients with resectable stage III skin melanoma. Participants will receive adjuvant therapy until disease progression, unacceptable toxicity, or the end of the 12-month treatment period. The study allows for radical surgical treatment in case of postoperative relapse if the lesions are resectable, following current clinical guidelines. The study aims to assess the safety and efficacy of this immunotherapy approach in managing melanoma.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed resectable stage IIIB/C/D skin melanoma and clinically detectable lymph nodes.

Not a fit: Patients with unresectable melanoma or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with resectable stage III skin melanoma by enhancing their response to therapy.

How similar studies have performed: Other studies using similar immunotherapy approaches have shown promising results, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol;
2. Age ≥ 18 years at the time of signing the informed consent form;
3. Histologically or cytologically confirmed (documented results of relevant studies are available) resectable stage IIIB/C/D skin melanoma;
4. 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
   * Non-palpable but enlarged (≥15 mm in smallest diameter, RECIST 1.1) lymph nodes with pathologically confirmed melanoma
5. Subject's consent to a biopsy;
6. Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ;
7. ECOG score 0-1;
8. Life expectancy of at least 5 years;
9. 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.

Exclusion Criteria:

1. Ocular melanoma;
2. Mucosal melanoma;
3. Distant metastases;
4. Impossibility of radical resection of the tumor, metastasis and/or involved lymph nodes;
5. Presence of only in-transit transit/satellite metastases without confirmed involvement of lymph nodes;
6. Prior therapy with checkpoint inhibitors (e.g. anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products);
7. Prior therapy with BRAF and MEK protein kinase inhibitors;
8. Prior radiation therapy;
9. Inability to determine BRAF status;
10. Subjects with severe comorbidities, with life-threatening acute complications of the underlying disease at the time of signing the informed consent form;
11. 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;
12. 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.) ;
13. A history of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids;
14. The need for glucocorticoid therapy (at \>10mg/day prednisolone equivalent doses) or any other drugs with immunosuppressive effects within 6 months prior to randomization;
15. Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study;
16. Hematological abnormalities :

    * neutrophils \<1.5×109/L;
    * platelets \<100×109/L;
    * hemoglobin \<90 g/L;
17. Renal impairment: creatinine ≥1.5×ULN;
18. 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;
19. Any surgery within less than 28 days prior to randomization in the study;
20. History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ;
21. Conditions limiting the subject's ability to comply with the Protocol requirements (in the Investigator's opinion );
22. Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ;
23. Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization;
24. Active hepatitis B, active hepatitis C (confirmed by PCR), HIV-infection, currently or previously ;
25. Impossibility to administer the investigational product intravenously;
26. Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media);
27. Hypersensitivity to any of the components of BCD-217, prolgolimab or pembrolizumab;
28. A history of hypersensitivity to monoclonal antibody products;
29. Pregnancy or breastfeeding.

Where this trial is running

Lesnoy and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Melanoma Stage IIIMelanomaPD-1CTLA-4prolgolimabnurulimabimmunotherapycheckpoint inhibitors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.