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Comparing BCD-263 and Opdivo for treating advanced melanoma

A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® As Monotherapy in Subjects with Advanced Melanoma of the Skin

Phase 3 Interventional Biocad · NCT06640530

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

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment392 (estimated)
Ages18 Years and up
SexAll
SponsorBiocad Industry-sponsored
Drugs / interventionsnivolumab, radiation
Locations45 sites (Brest and 44 other locations)
Trial IDNCT06640530 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of BCD-263 compared to Opdivo in patients with advanced unresectable or metastatic melanoma. Participants will be randomly assigned to receive either treatment intravenously until disease progression or unacceptable toxicity occurs. After 25 weeks, all subjects will continue receiving BCD-263 for up to two years or until disease progression. The study will also include a follow-up period to assess overall survival through telephone contacts.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced unresectable or metastatic melanoma.

Not a fit: Patients with rapidly progressing metastatic melanoma or significant symptoms associated with the tumor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed informed consent and the subject's ability to comply with the protocol requirements.
2. Age ≥18 years at the time of signing the informed consent form.
3. Histologically confirmed melanoma with the following prognostic characteristics:

   * LDH \<ULN of local laboratory (enrollment of subjects with LDH \<2 x 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.
5. Presence of a tumor sample (archived or new biopsy) that is suitable for evaluation for PD L1 expression in the Investigator's opinion.
6. At least one measurable lesion as per RECIST 1.1 based on independent central review.
7. ECOG score 0-1.
8. Laboratory test results consistent with adequate functioning of systems and organs.

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.
4. Active CNS metastases and/or carcinomatous meningitis.
5. Previous invasive cancer, excluding diseases treated with potentially radical 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.
8. Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders \[vitiligo, alopecia, or psoriasis\] not requiring systemic therapy are eligible to participate).
9. The need for systemic corticosteroids (at doses equivalent to \>10 mg/day prednisolone) or any other immunosuppressive drugs within 14 days prior to randomization. The use of inhaled and topical corticosteroids is allowed.
10. History of (non-infectious) pneumonitis requiring corticosteroid therapy or pneumonitis at the time of screening.
11. Any anticancer therapy or major surgery within 28 days prior to randomization, or the subject's AE (other than alopecia) caused by anticancer therapy has not yet recovered to CTCAE grade 1 or has not completely resolved.
12. Concomitant use of drugs or medical devices studied in other clinical studies or their use within 28 days prior to randomization.
13. Infections requiring therapy or systemic antibiotics within 14 days prior to randomization.
14. Administration of a live and/or attenuated vaccine within 28 days prior to randomization.
15. Positive HIV-1 or HIV-2 test.
16. HBV/HCV infections (subjects with a negative PCR result for hepatitis C virus RNA, without significant abnormalities in blood chemistry tests, examined by an infectious disease specialist and not requiring specific antiviral treatment at the time of screening, may be included in the study. Subjects with a positive HbsAg test result cannot be included in the study).
17. Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media).
18. Hypersensitivity or allergy to any of the nivolumab product components. Hypersensitivity or allergy to medicinal products obtained based on Chinese hamster ovary cells, or history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or hybrid proteins.
19. Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.

Where this trial is running

Brest and 44 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 MelanomaMelanoma
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.