Status:
ACTIVE_NOT_RECRUITING
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
Lead Sponsor:
Biocad
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intraveno...
Detailed Description
Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period. During the main study period, subjects will receive therapy with B...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of signing the informed consent form;
- Body weight 60 to 90 kg.
- Histologically confirmed melanoma with the following prognostic characteristics:
- LDH \<ULN of local laboratory (enrollment of subjects with LDH \<2x ULN of local laboratory is allowed until the number of subjects with LDH \>ULN is 30% of the total population of randomized subjects. The Sponsor will inform when enrollment of subjects is limited by LDH level \<ULN of the local laboratory).
- Absence, according to the Investigator, of clinically significant symptoms associated with the tumor.
- Absence, according to the Investigator, of rapidly progressing metastatic melanoma.
- Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.
Exclusion
- Indications for radical treatment (surgery, radiation therapy).
- Uveal or mucosal melanoma.
- Previous systemic anticancer therapy for advanced unresectable or metastatic skin melanoma (a history of neoadjuvant or adjuvant therapy is allowed, provided that the therapy was completed at least 12 weeks before randomization).
- Active CNS metastases and/or carcinomatous meningitis.
- Previous invasive cancer, excluding diseases treated with potentially curative therapy with no evidence of recurrence for 2 years from the start of this therapy (subjects with radically resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ of the uterus and other carcinomas in situ may be included).
- Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period.
- Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.
Key Trial Info
Start Date :
May 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06112808
Start Date
May 29 2023
End Date
January 1 2027
Last Update
July 8 2025
Active Locations (30)
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1
Healthcare Institution "Minsk City Clinical Cancer Center"
Minsk, Belarus, 220013
2
State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov"
Minsk, Belarus, 223040
3
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
4
JSC "Modern Medical Technologies"
Saint Petersburg, Sankt-Peterburg, Russia, 190013