Unresectable or Metastatic MelanomaPhase 3FLATNCT05783882
Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
A Phase 3 study testing Prolgolimab in people with Unresectable or Metastatic Melanoma, run by Biocad at 6 sites in Russia.
Trial summary
Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable or Metastatic Melanoma
- What is being tested?
- Prolgolimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 6 sitesRussia
- Study dates
- 1 Feb 2022to Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 informed consent.
- Histologically confirmed unresectable or metastatic melanoma (with available documented evidence of relevant examinations).
- Primarily detected advanced or metastatic melanoma, or the disease progression on or after previous systemic therapy.
- Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria, confirmed by an independent reviewer.
- ECOG score 0-1.
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- Absence of severe organ and system disorders.
- Life expectancy of at least 12 weeks at screening.
- For patients of childbearing potential: willingness to use reliable methods of contraception throughout the study, from the time of informed consent and for up to 6 weeks after the last dose of the study drug.
- Available blocks for a histological examination and/or the patient's consent for collection of biopsy43 samples to obtain histological material to assess the PD-L1 status.
Who cannot join
- Patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis) at the time of informed consent.
- CNS metastases that are progressing or associated with clinical symptoms (e.g., cerebral edema, spinal compression) or requiring the use of glucocorticosteroids and/or anticonvulsants;
- Ongoing concomitant diseases at the time of screening increasing the risk of severe adverse events during the study treatment.
- The need for glucocorticoids or any other drugs with immunosuppressive effects.
- Hematologic abnormalities.
- Renal impairment.
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- Hepatic impairment.
- Increased LDH >2 ULN.
- Prior treatment with anti-CTLA4 and/or anti-PD-1/PD-L1/PDL-2 drugs.
- Prior targeted therapy.
- A history of malignancies, except for radically treated diseases in remission for over 5 years prior to starting the study.
- Conditions limiting the patient's ability to comply with the protocol requirements (dementia, neurologic or mental disorders, drug or alcohol addiction, etc).
- Simultaneous participation in other clinical studies55 or participation in other clinical studies within 30 days prior to starting the study treatmen.
- Acute infections or activation of chronic infectious diseases within 28 days prior to the beginning of the study treatment.
- Active hepatitis B, active hepatitis C, HIV-infection, syphilis.
- Impossibility to administer the study drug intravenously.
- Impossibility to perform imaging examinations requiring administration of intravenous contrast media.
- Hypersensitivity to any of the components of BCD-100.
- A history of hypersensitivity to monoclonal antibody products.
- Pregnancy or breastfeeding.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Regional Clinical Oncology Dispensary" (SBHI AR ARCOD)
Arkhangelsk
State Budgetary Institution of Healthcare "Clinical Oncology Dispensary of Chelyabinsk Region" (SBIH CODCR)
Chelyabinsk
N.N. Blokhin Russian Cancer Research Center
Moscow
State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD)
Moscow
Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation, Research Department of the Innovative Methods of Therapeutic Oncology and Rehabilitation
Saint Petersburg
Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg
About this study
Official title: Multicenter Open-label Study of the Efficacy, Pharmacokinetica and Safety of Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data.
The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as:
- selection criteria for subjects in the study, defining the population,
- research centers,
- procedures for evaluating effectiveness and safety,
- permitted prior and concomitant therapy of the underlying disease.
- Conditions
- Unresectable or Metastatic Melanoma
- Being tested
- Prolgolimab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlgolimabDrug
250 mg Q3W
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Prolgolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate (partial response+complete response rates) according to RECIST 1.1
Measured: 6 month
Secondary outcomes (6)
Overall response rate
Overall response rate (partial response+complete response rates) according to irRECIST
Measured: 6 month
Disease control rate
Disease control rate (stabilization + partial response + complete response rates) according to RECIST 1.1
Measured: 6 month
Disease control rate
Disease control rate (stabilization + partial response + complete response rates) according to irRECIST
Measured: 6 month
Time to response
The time from the frirst administered dose to the response (partial or complete) according to RECIST 1.1
Measured: 6 month
Time to response
The time from the frirst administered dose to the response (partial or complete) according to irRECIST
Measured: 6 month
Duration of Response
Time from the response (partial or complete) repoerted date to the progression or death.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Feb 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable or Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783882
- Sponsor's protocol ID
- BCD-100-8
- Acronym
- FLAT
- Status last verified
- Jan 2023
- First submitted
- 2 Feb 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tjulandin S, Demidov L, Moiseyenko V, Protsenko S, Semiglazova T, Odintsova S, Zukov R, Lazarev S, Makarova Y, Nechaeva M, Sakaeva D, Andreev A, Tarasova A, Fadeyeva N, Shustova M, Kuryshev I. Novel PD-1 inhibitor prolgolimab: expanding non-resectable/metastatic melanoma therapy choice. Eur J Cancer. 2021 May;149:222-232. doi: 10.1016/j.ejca.2021.02.030. Epub 2021 Apr 17.
PubMed 33872982
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open-label Study of the Efficacy, Pharmacokinetica and Safety of Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT05783882
- Acronym / sponsor ID
- FLAT / BCD-100-8
- Conditions
- Unresectable or Metastatic Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data.
The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as:
- selection criteria for subjects in the study, defining the population,
- research centers,
- procedures for evaluating effectiveness and safety,
- permitted prior and concomitant therapy of the underlying disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Prolgolimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent and the subject's ability to comply with the protocol requirements.
- Age ≥18 years at the time of informed consent.
- Histologically confirmed unresectable or metastatic melanoma (with available documented evidence of relevant examinations).
- Primarily detected advanced or metastatic melanoma, or the disease progression on or after previous systemic therapy.
- Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria, confirmed by an independent reviewer.
Key exclusion criteria (20 listed)
- Patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis) at the time of informed consent.
- CNS metastases that are progressing or associated with clinical symptoms (e.g., cerebral edema, spinal compression) or requiring the use of glucocorticosteroids and/or anticonvulsants;
- Ongoing concomitant diseases at the time of screening increasing the risk of severe adverse events during the study treatment.
- The need for glucocorticoids or any other drugs with immunosuppressive effects.
- Hematologic abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolgolimab250 mg Q3W | Drug | Arm 1 |
Primary outcome
Overall response rate
Time frame: 6 month
Overall response rate (partial response+complete response rates) according to RECIST 1.1
6 secondary outcomes
Overall response rate
Time frame: 6 month
Disease control rate
Time frame: 6 month
Disease control rate
Time frame: 6 month
Time to response
Time frame: 6 month
Time to response
Time frame: 6 month
Duration of Response
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 33872982Tjulandin S, Demidov L, Moiseyenko V, Protsenko S, Semiglazova T, Odintsova S, Zukov R, Lazarev S, Makarova Y, Nechaeva M, Sakaeva D, Andreev A, Tarasova A, Fadeyeva N, Shustova M, Kuryshev I. Novel PD-1 inhibitor prolgolimab: expanding non-resectable/metastatic melanoma therapy choice. Eur J Cancer. 2021 May;149:222-232. doi: 10.1016/j.ejca.2021.02.030. Epub 2021 Apr 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prolgolimab in people with Unresectable or Metastatic Melanoma, run by Biocad at 6 sites in Russia.
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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. 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?
Results are not available in the source record.
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 (time frame: 6 month). 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 NCT05783882, which also lists 1 linked publication.
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 24 Mar 2023.