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Advanced MelanomaPhase 3UNIVERSENCT06640530

Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

A Phase 3 study testing BCD-263 and Opdivo in people with Advanced Melanoma and Melanoma (Skin), run by Biocad at 44 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma, Melanoma (Skin)
What is being tested?
BCD-263 and Opdivo
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
44 sitesin 3 countries
Study dates
21 Mar 2024to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent and the subject's ability to comply with the protocol requirements.
  • Age ≥18 years at the time of signing the informed consent form.
  • 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.
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  • Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.
  • Presence of a tumor sample (archived or new biopsy) that is suitable for evaluation for PD L1 expression in the Investigator's opinion.
  • At least one measurable lesion as per RECIST 1.1 based on independent central review.
  • ECOG score 0-1.
  • Laboratory test results consistent with adequate functioning of systems and organs.

Who cannot join

  • Indications for radical treatment (surgery, radiation therapy).
  • Uveal or mucosal melanoma.
  • Previous systemic anticancer therapy for advanced unresectable or metastatic skin melanoma.
  • Active CNS metastases and/or carcinomatous meningitis.
  • 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).
  • 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.
Show all 19Show fewer
  • Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.
  • 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).
  • 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.
  • History of (non-infectious) pneumonitis requiring corticosteroid therapy or pneumonitis at the time of screening.
  • 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.
  • Concomitant use of drugs or medical devices studied in other clinical studies or their use within 28 days prior to randomization.
  • Infections requiring therapy or systemic antibiotics within 14 days prior to randomization.
  • Administration of a live and/or attenuated vaccine within 28 days prior to randomization.
  • Positive HIV-1 or HIV-2 test.
  • 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).
  • Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media).
  • 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.
  • Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.

Trial locations and contacts

44 sites in 3 countries.

44 sites in 3 countries

Russia38 sites

  • State Budgetary Institution of Healthcare of the Arkhangelsk Region "Severodvinsk City Hospital №2 of Emergency"

    Arkhangelsk, 164523

  • Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

    Barnaul, 656045

  • Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Ivanovo Regional Oncology Center

    Ivanovo, 153013

  • State Health Care Institution "Republican Clinical Cancer Center," the Ministry of Health of the Udmurt Republic

    Izhevsk, 426009

  • State Budgetary Health Institution "Regional Clinical Hospital of Kaliningrad Region"

    Kaliningrad

  • State Budgetary Healthcare Institution of Kaluga Region "Kaluga Region Clinical Oncological Dispensary"

    Kaluga, 248007

  • State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"

    Kazan'

  • Clinical Oncologic Dispensary No. 1

    Krasnodar, Krasnodar Kari, 350040

  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

    Moscow, 115478

  • JSC "Medsi Group"

    Moscow

  • Moscow City Oncology Hospital No. 62

    Moscow

  • State budgetary health care institution of the city of Moscow "City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow"

    Moscow

  • State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD)

    Moscow

  • State Budgetary Institution of Healthcare of the City of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Health of the City of Moscow"

    Moscow

  • Nizhny Novgorod Region State Budgetary Healthcare Institution "Nizhny Novgorod Regional Clinical Oncological Dispensary"

    Nizhny Novgorod, 603126

  • State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region

    Novosibirsk

  • State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

    Omsk

  • Perm Region Oncology Dispensary

    Perm, 614066

  • State Budgetary Healthcare Institution of Perm Krai "Order of Honour" Perm Regional Clinical Hospital "

    Perm

  • Federal Government Budgetary Institution "National Institute of Cancer Research" of Ministry of Health of Russian Federation

    Rostov-on-Don, 314019

  • JSC "Modern Medical Technologies"

    Saint Petersburg, Sankt-Peterburg, 190013

  • Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Saint Petersburg"

    Saint Petersburg, 195271

  • Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation

    Saint Petersburg

  • JSC "North-West Centre of Evidence-Based Mediccine"

    Saint Petersburg

  • Limited Liability Company "Oncological Research Center"

    Saint Petersburg

  • Private Medical Institution Evromedservis

    Saint Petersburg

  • State-financed Health Institution "Samara Region Clinical Oncology Dispensary"

    Samara, 443031

  • Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

    Saransk

  • Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"

    Smolensk, 214000

  • Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

    Tomsk

  • Federal State Budgetary Institution of Health "Tver Regional Clinical Oncological Dispensary" of the Tver Region

    Tver'

  • State Autonomus Institution of Health "Mulitiprofile Clinical Medical Centre "Medical City""

    Tyumen

  • Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

    Ufa, 450054

  • State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"

    Volgograd

  • Sverdlovsk Regional Oncology Center

    Yekaterinburg

Other trials in Russia

Belarus4 sites

  • Healthcare Institution "Brest Regional Oncological Dispensary"

    Brest

  • Health Institution "Gomel Regional Clinical Oncology Center"

    Homyel

  • Healthcare Institution "Minsk City Clinical Cancer Center"

    Minsk, 220013

  • State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov"

    Minsk, 223040

Other trials in Belarus

Pakistan2 sites

  • Shaheed Zulfiqar Ali Bhutto Medical University

    Islamabad

  • Rehman Medical Institute

    Peshawar

Other trials in Pakistan

About this study

Official title: 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

The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin.

Read the 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 BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier).

At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first).

Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.

Being tested
BCD-263, Opdivo
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-263Drug

    Also called Nivolumab

    BCD-263 at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

  • OpdivoDrug

    Also called Nivolumab

    Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

Study groups in NCT06640530
Study groupRoleWhat they receive
BCD-263ExperimentalBCD-263 will be administered during main period and open-label period
Receives: Drug: BCD-263
OpdivoActive comparatorOpdivo will be administered during main period
Receives: Drug: Opdivo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR) according to RECIST 1.1

    To compare the overall response rates (ORRs) after administration of BCD-263 and Opdivo in subjects with advanced unresectable or metastatic skin melanoma

    Measured: Week 25

Secondary outcomes (7)

  1. Time to response

    To compare time to response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: Week 25

  2. Duration of response

    To compare duration of response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  3. DCR

    To compare disease control rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  4. PFS

    To compare progression-free survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  5. Overall survival

    To compare overall survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  6. Safety assessment

    The subjects will undergo the vital sign assessment, physical and instrumental examination, sampling for complete blood count, blood chemistry, thyroid hormone tests, and urinalysis, as well as assessment of the presence and characteristics of adverse events to assess the safety of the investigational product

    Measured: Through week 105

  7. Immunogenicity assessment

    Proportion of subjects with binding and/or neutralizing antibodies to nivolumab

    Measured: Through week 105

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start21 Mar 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
392 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06640530
Sponsor's protocol ID
BCD-263-2
Acronym
UNIVERSE
Status last verified
Jul 2025
First submitted
11 Oct 2024
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-263 and Opdivo in people with Advanced Melanoma and Melanoma (Skin), run by Biocad at 44 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Russia, Belarus, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) according to RECIST 1.1 (time frame: Week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06640530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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