Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03472027
Eligibility Criteria:
Inclusion Criteria:
1. Patient provides a written informed consent and is able to follow the requirements of the Protocol;
2. Age ≥ 18 years
3. Histologically confirmed (well-documented test results; preferably, block specimens available) unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
4. ECOG score of 0 to 2;
5. Measurable disease (at least one lesion) according to RECIST v1.1 ;
6. Resolved toxicity events from the previous therapy or adverse consequences of surgical interventions to ≤ grade 1 CTCAE v. 4.03, except for chronic/irreversible adverse events not affecting the safety of the study therapy (e.g. alopecia);
7. No severe pathology of organs or systems;
8. Life expectancy of at least 16 weeks from the screening;
9. Patients of childbearing potential enrolled in the study must agree to use reliable contraception methods throughout the study period, beginning 2 weeks before the inclusion in the study and up to 8 weeks after the last dose of BCD-145.
Exclusion Criteria:
1. Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of \>50% renal parenchyma);
2. Brain metastases ;
3. Severe cardiovascular disorders within 6 months before screening;
4. Autoimmune diseases;
5. Conditions requiring steroids or any other immunosuppressants;
6. Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
7. Renal function impairment: creatinine ≥1.5 × ULN;
8. Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
9. Endocrine disorders: abnormal thyroid hormones
10. Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
11. Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
12. Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
13. Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
14. Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
15. Simultaneous participation in any other clinical trial; participation in other clinical trials within 30 days before inclusion in the present study; previous participation in the present study.
16. Acute infections or active chronic infections;
17. Documented hepatitis B, active hepatitis C, HIV or syphilis infection;
18. Intravenous administration of the drug is impossible;
19. Intravenous administration of contrast agents is impossible;
20. Hypersensitivity to any component of BCD-145.
21. Known history of hypersensitivity to monoclonal antibodies;
22. Pregnancy or breastfeeding;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03472027
Study Brief:
Protocol Section:
NCT03472027