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Comparing BCD-263 and Opdivo for advanced melanoma treatment

A Double-Blind, Randomized Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

Phase 1 Interventional Biocad · NCT06112808

This study is testing whether a new treatment called BCD-263 works as well as Opdivo for people with advanced melanoma that can't be surgically removed.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorBiocad Industry-sponsored
Drugs / interventionsradiation
Locations30 sites (Minsk and 29 other locations)
Trial IDNCT06112808 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the pharmacokinetics, safety, immunogenicity, and pharmacodynamic profiles of BCD-263 compared to Opdivo in patients with advanced unresectable or metastatic melanoma. Participants will be randomly assigned to receive either BCD-263 or Opdivo intravenously in a double-blind manner. The treatment will continue until disease progression or unacceptable toxicity occurs, followed by a follow-up period to assess overall survival. The study seeks to establish the comparability of these two therapies in managing advanced melanoma.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced unresectable or metastatic melanoma who meet specific health criteria.

Not a fit: Patients with indications for radical treatment or those with uveal or mucosal melanoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced melanoma, potentially improving outcomes and safety profiles.

How similar studies have performed: While this approach is novel in comparing BCD-263 to Opdivo, similar studies have shown promise in evaluating new therapies for advanced melanoma.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years at the time of signing the informed consent form;
2. Body weight 60 to 90 kg.
3. 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.
4. Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.

Exclusion Criteria:

1. Indications for radical treatment (surgery, radiation therapy).
2. Uveal or mucosal melanoma.
3. 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).
4. Active CNS metastases and/or carcinomatous meningitis.
5. 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).
6. 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.
7. Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.

Where this trial is running

Minsk and 29 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 Advanced Melanoma
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.