Clinical study BCD-217-3/NEO-MIMAJOR: 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 Stage III Resectable Skin Melanoma
The BCD-217-3/NEO-MIMAJOR clinical study will evaluate the efficacy and safety of neoadjuvant (preoperative) therapy with BCD-217 followed by anti-PD-1 adjuvant therapy versus standard adjuvant therapy with pembrolizumab in potential participants who have:
histologically or cytologically confirmed resectable stage III B/C/D skin melanoma;
reached the age of 18 years.
≥ 1 clinically detectable lymph node amenable for biopsy and ≥ 3 resectable in-transit metastases. The definition of clinically detectable lymph nodes includes:
palpable lymph nodes with pathologically confirmed melanoma;
impalpable but enlarged (≥ 15 mm in the smallest diameter) lymph nodes with pathologically confirmed melanoma.
An ECOG score of 0–11.
Consented to use reliable contraceptive measures throughout the study and for at least 24 weeks after the last dose of study therapy.
The clinical study protocol requires potential participants to undergo a biopsy of the affected lymph node.
This study has exclusion criteria (criteria of ineligibility for a clinical study). Investigators will communicate the full list of the exclusion criteria to potential participants. Some exclusion criteria are:
Ocular melanoma;
Mucosal melanoma;
Distant metastases2;
Ineligibility for radical resection of the tumor, metastasis, and/or affected lymph nodes;
Presence of only in-transit/satellite metastases without confirmed lymph node involvement;
Prior therapy with BRAF5 and MEK6 protein kinase inhibitors;
Prior radiotherapy;
Indeterminable BRAF status;
Severe comorbidities with life-threatening acute complications of the underlying disease at the time of signing the informed consent form;
Comorbidities that persist at the screening and increase the risk of adverse events during surgery and/or study therapy;
Confirmed or suspected systemic autoimmune disease (including, but not limited to, systemic lupus erythematosus, Crohn’s disease, ulcerative colitis (UC), systemic scleroderma, inflammatory myopathy, mixed forms of connective tissue disease, overlapping syndrome, etc.);
A positive history of interstitial lung disease or pneumonitis requiring systemic glucocorticoids;
Therapy with glucocorticoids (≥ 10 mg/day prednisolone equivalents) and other immunosuppressive agents within 6 months prior to randomization7;
Administration of immunostimulants, monoclonal antibodies, and/or colony-stimulating factors within 4 weeks prior to randomization in the study;
Hematologic abnormalities:
neutrophils <1.5 × 109/L
platelets <100 × 10M9/L
hemoglobin <90 g/L
Renal impairment: creatinine ≥1.5 × ULN;
Hepatic impairment:
Total bilirubin ≥1.3 × ULN (≥50 μmol/L for potential participants with Gilbert’s syndrome),
ALP, AST or ALT ≥1.5 × ULN;
A positive history of any malignancy except for radically treated malignancy with remission for over 5 years prior to randomization in this study;
Participation in other clinical studies within 30 days prior to randomization and during this clinical study;
Acute infections, active chronic infections or systemic antibacterial therapy within 28 days prior to randomization;
Active hepatitis B, active hepatitis C (confirmed by PCR), HIV-infection, including a positive history thereof;
Unobtainable intravenous access precluding administration of the test drug;
Ineligibility to the administration of contrast media (including hypersensitivity to contrast media);
A positive history of hypersensitivity to monoclonal antibodies;
Pregnancy or breastfeeding.
The study centers of the BCD-217-3/NEO-MIMAJOR study are located in the cities of the Russian Federation and Republic of Belarus, such as St. Petersburg, Moscow, Novosibirsk, Omsk, Sochi, Saransk, Chelyabinsk, Nizhny Novgorod, Kemerovo, Krasnodar, Volgograd, Obninsk, Kazan, Minsk, Gomel, Vitebsk, Brest, Barnaul, Krasnogorsk, Ufa, Krasnoyarsk, Almaty, Astana.
You can ask questions about participating in the clinical study and clarify contact information of study centers through the form «Do you have any questions?»
Investigators will explain the other eligibility criteria and contraindications for participation in this clinical study to potential participants. The potential participant should review the full details of the study and consult with the investigator and/or attending physician.
Clinical study authorization No. 52 of the Ministry of Health of the Russian Federation dated February 06, 2023, and the list of approved study centers in the Russian Federation have been published in the State Registry of Medicines.
Clinical study authorization No. 67/102/2023 of the Ministry of Health of the Republic of Belarus dated November 26, 2022, and the list of approved study centers in the Republic of Belarus have been published in the State Registry of Medicines of the Republic of Belarus.
The ECOG scale measures the functional status of the patient in terms of his/her ability to take care of himself/herself, daily activities, and physical activity.
Metastasis to internal organs and/or the brain
Biotechnology-derived monoclonal antibodies that are used as immune checkpoint inhibitors to enhance the antitumor immune response
Biotechnology-derived monoclonal antibodies that are used as immune checkpoint inhibitors to enhance the antitumor immune response