A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

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A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05751928
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biocad
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Belarus, Russia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma Stage III, Melanoma (Skin)

Additional Details

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.

Arms & Interventions

Arms

Experimental: Subjects with pCR and pnCR (Group 1A)

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.

Experimental: Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)

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.

Active Comparator: Control Group (Group 2)

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.

Interventions

Biological: - BCD-217

BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting

Biological: - anti-PD1

anti-PD1 agent in the adjuvant setting

Procedure: - Excision of the primary lesion

Excision of the primary lesion will be performed per standard of care.

Procedure: - Regional lymphadenectomy

Regional lymphadenectomy will be performed per standard of care.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Lesnoy 8148652, Belarus

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State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"

Lesnoy 8148652, ,

Minsk 625144, Belarus

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Healthcare Institution "Minsk City Clinical Cancer Center"

Minsk 625144, , 220013

Mogilev 625665, Belarus

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State Institution "Mogilev Regional Oncological Dispensary"

Mogilev 625665, ,

Vitebsk 620127, Belarus

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Healthcare Institution "Vitebsk Regional Clinical Oncology Center"

Vitebsk 620127, ,

Clinical Oncologic Dispensary No. 1, Krasnodar 542420, Krasnodar Kari, Russia

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Clinical Oncologic Dispensary No. 1

Krasnodar 542420, Krasnodar Kari, 350040

Clinical Oncologic Dispensary No. 2, Sochi 491422, Krasnodar Territory, Russia

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Clinical Oncologic Dispensary No. 2

Sochi 491422, Krasnodar Territory, 354057

Regional Clinical Oncology Hospital, Yaroslavl 468902, Yaroslavl Oblast 468898, Russia

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Regional Clinical Oncology Hospital

Yaroslavl 468902, Yaroslavl Oblast 468898, 150054

Chelyabinsk 1508291, Russia

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State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",

Chelyabinsk 1508291, , 454087

Gatchina 561887, Russia

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State budgetary healthcare institution Leningrad Regional Clinical Hospital

Gatchina 561887, ,

Kazan' 551487, Russia

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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' 551487, ,

Kemerovo 1503901, Russia

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State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"

Kemerovo 1503901, ,

Kostroma 543878, Russia

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Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"

Kostroma 543878, , 156005

Kuz'molovskiy 537771, Russia

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State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"

Kuz'molovskiy 537771, ,

Moscow 524901, Russia

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"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

Moscow 524901, ,

Moscow 524901, Russia

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Branch of Hadassah Medical LTD Limited Liability Company

Moscow 524901, ,

Moscow 524901, Russia

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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 524901, ,

Joint Stock Company "K31 City", Moscow 524901, Russia

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Joint Stock Company "K31 City"

Moscow 524901, ,

JSC "Medsi Group", Moscow 524901, Russia

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JSC "Medsi Group"

Moscow 524901, ,

Moscow City Oncology Hospital No. 62, Moscow 524901, Russia

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Moscow City Oncology Hospital No. 62

Moscow 524901, ,

Moscow 524901, Russia

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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 524901, ,

Nizhny Novgorod 520555, Russia

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Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"

Nizhny Novgorod 520555, , 603006

LLC "DobroMed", Novosibirsk 1496747, Russia

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LLC "DobroMed"

Novosibirsk 1496747, ,

Novosibirsk 1496747, Russia

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State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region

Novosibirsk 1496747, ,

Obninsk 516436, Russia

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Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

Obninsk 516436, ,

Omsk 1496153, Russia

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Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"

Omsk 1496153, ,

JSC "Modern Medical Technologies", Saint Petersburg 498817, Russia

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JSC "Modern Medical Technologies"

Saint Petersburg 498817, , 190013

Saint Petersburg 498817, Russia

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Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

Saint Petersburg 498817, , 197758

City Hospital #40, Kurortny district, Saint Petersburg 498817, Russia

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City Hospital #40, Kurortny district

Saint Petersburg 498817, ,

Saint Petersburg 498817, Russia

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Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"

Saint Petersburg 498817, ,

Saint Petersburg 498817, Russia

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Limited Liability Company "American Medical Clinic"

Saint Petersburg 498817, ,

Saint Petersburg 498817, Russia

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Limited Liability Company "Oncological Research Center"

Saint Petersburg 498817, ,

Saint Petersburg 498817, Russia

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Limited Liability Company "Strategic Medical Systems"

Saint Petersburg 498817, ,

Saint Petersburg 498817, Russia

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N.N. Petrov National Medicine Research Center of oncology

Saint Petersburg 498817, ,

Saint Petersburg 498817, Russia

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Private Medical Institution Evromedservis

Saint Petersburg 498817, ,

Saransk 498698, Russia

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Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

Saransk 498698, ,

Volgograd 472757, Russia

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State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"

Volgograd 472757, ,

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