MelanomaPhase 2NCT04928365
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
A Phase 2 study testing Anti-PD-1 monoclonal antibody in people with Melanoma, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Anti-PD-1 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 25 Mar 2021to 25 Mar 2023
- Phase
- Phase 2
- 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
- Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
- ECOG 0-1
- Age of patients - 18 years and older
- No prior chemotherapy, immunotherapy, radiation or hormonal therapy
- Adequate contraception for women of childbearing age
- Written consent of the patient to participate in the study
Who cannot join
- Non-compliance with the previously listed criteria
- Pregnancy and breastfeeding
- Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
- History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
Moscow, 115478
Irina N Mikhaylova, DSc, 8 499 324 90 24, irmikhaylova@gmail.com
About this study
Official title: Open Prospective Clinical Trial to Develop the Computer Software (Intelligent Prognostic System) for Predicting the Efficacy of Anti-PD-1 Immunotherapy of Melanoma Patients in Routine Practice
Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice
- Conditions
- Melanoma
- Being tested
- Anti-PD-1 monoclonal antibody
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 monoclonal antibodyDrug
Anti-PD-1 therapy
| Study group | Role | What they receive |
|---|---|---|
| Advanced melanoma patients | Other | Not described Receives: Drug: Anti-PD-1 monoclonal antibody |
| Stage III and IV melanoma patients after radical surgery | Other | Not described Receives: Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: up to 12 months
Progression free survival
Measured: up to 12 months
Secondary outcomes (1)
Cytokine profile
IL-2, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-22, (IFN)-α2, IFN-γ, NFβ/Lymphotoxin-α(LTA), MCP-1/CCL2,IP-10/CXCL10, MIG/CXCL9, GM-CSF, PDGF-AA, PDGF-AB/BB, VEGF-A
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start25 Mar 2021
- Primary completion11 May 2021
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Mikhaylova, Blokhin's Russian Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928365
- Sponsor's protocol ID
- Cytokim-01
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Prospective Clinical Trial to Develop the Computer Software (Intelligent Prognostic System) for Predicting the Efficacy of Anti-PD-1 Immunotherapy of Melanoma Patients in Routine Practice
- ClinicalTrials.gov ID
- NCT04928365
- Acronym / sponsor ID
- Cytokim-01
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 16 Jun 2021 (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.
Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced melanoma patients | Other | Drug: Anti-PD-1 monoclonal antibody |
| Stage III and IV melanoma patients after radical surgery | Other | Drug: Anti-PD-1 monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
- ECOG 0-1
- Age of patients - 18 years and older
- No prior chemotherapy, immunotherapy, radiation or hormonal therapy
- Adequate contraception for women of childbearing age
Key exclusion criteria (4 listed)
- Non-compliance with the previously listed criteria
- Pregnancy and breastfeeding
- Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
- History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
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 |
|---|---|---|
| Anti-PD-1 monoclonal antibodyAnti-PD-1 therapy | Drug | Advanced melanoma patients, Stage III and IV melanoma patients after radical surgery |
Primary outcome
Overall survival
Time frame: up to 12 months
Progression free survival
Time frame: up to 12 months
1 secondary outcome
Cytokine profile
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-PD-1 monoclonal antibody in people with Melanoma, run by Blokhin's Russian Cancer Research Center at 1 site 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 6 inclusion and 4 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Irina N Mikhaylova, DSc (8 499 324 90 24, irmikhaylova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2021.