Melanoma, SkinCRISTINANCT06299878
MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]
An observational study of Melanoma, Skin and Melanoma Stage Iii, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin, Melanoma Stage Iii
- What is being tested?
- Gut microbiota analysis
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2022to 1 Jul 2025
- Phase
- Observational
- 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
Study population: No specific requurements to study population
Who may be able to join
- Patients aged 18 years and older.
- Performance status according to the Eastern Cooperative Oncology Group (ECOG) of 0-1.
- Patients who have not previously received immunotherapy with anti-PD1, anti-PDL1, or anti-CTLA4 agents.
- Clinical stage III (B-D), i.e., with clinically or radiologically determined metastatic changes in lymph nodes.
- Histologically confirmed involvement of regional lymph nodes.
- Lesions assessable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Who cannot join
- Patients with melanoma of non-skin localizations.
- Patients with active autoimmune diseases.
- Patients with active infectious diseases.
- Patients with severe concomitant diseases with an ECOG status \>1.
- Pregnant or lactating patients.
- Patients requiring the intake of glucocorticoids at a dose greater than 10 mg of prednisone (or equivalent) per day.
- Patients requiring the use of, or having received, systemic antibiotics within 4 weeks prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin Russian Cancer Research Center, skin tumor department
Moscow, 115478
Igor V Samoylenko, MD, PhD, +7 (499) 444-24-24, i.samoylenko@ronc.ru
Angelina O Kuzmenko, MD, +74993249024, angelin.kuzmenko@gmail.com
About this study
Official title: Neoadjuvant Monotherapy With Anti-PD1 Agents in Patients With Resectable Stage IIIB-D Melanoma: Analysis of Novel Biomarkers
The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:
- radiological and pathological response rate to three doses of antiPD1 agents;
- do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.
After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.
Read the detailed description
The clinical efficacy of PD1 inhibitors on the 2-year recurrence-free survival of patients with resectable stage III B-D melanoma will be assessed. This indicator will be compared with a historical control group using adjuvant PD1 immunotherapy and targeted therapy. Various factors will be analyzed for their potential impact on immunotherapy effectiveness, including demographics, disease stage and sub-stage, molecular-genetic status of the tumor, composition of the tumor\'s lymphoid infiltrate, LDH levels, gut microbiome composition, radiological and pathological response to treatment, and the development of immune-mediated adverse events. These findings may help optimize treatment by implementing neoadjuvant therapy for stage III B-D cutaneous melanoma.
- Conditions
- Melanoma, Skin, Melanoma Stage Iii
- Being tested
- Gut microbiota analysis
- Keywords
- neoadjuvant therapy, stage IIIB-D resectable melanoma, gut microbiota
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut microbiota analysisDiagnostic test
Patients with resectable stage IIIB-D melanoma will have a lymph node core biopsy to confirm metastatic lesions, following standard procedures. Additionally, a portion of the tumor tissue will be preserved for biomarker analysis. Participants will then be instructed to submit fecal samples and complete a dietary questionnaire before receiving three doses of PD1 monotherapy, in accordance with the center\'s routine practice, typically spanning 6-10 weeks. Between weeks 10 and 12, a radiological assessment of the response will be conducted. Following this, participants will undergo regional lymphadenectomy, and the pathological response will be evaluated. After surgery, patients will be placed on adjuvant therapy for 12 months as per routine practice of the center . Subsequently, they will be monitored for five years, adhering to the institution\'s standard follow-up protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Neoadjuvant Receives: Diagnostic Test: Gut microbiota analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year disease-free survival
2-year disease-free survival: time from surgery to disease recurrence (either locoregional or distant) or death from any cause
Measured: time from surgery and up to 2 years follow up
Secondary outcomes (1)
pathological response rate
Rate of pathological complete response, near-to-pCR, non-pCR/disease progression
Measured: from enrollment to surgery (in average up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma, SkinStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Samoylenko, Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299878
- Sponsor's protocol ID
- MelPRO-0322
- Acronym
- CRISTINA
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD data could be aggregated later with another neoadjuvant study
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Monotherapy With Anti-PD1 Agents in Patients With Resectable Stage IIIB-D Melanoma: Analysis of Novel Biomarkers
- ClinicalTrials.gov ID
- NCT06299878
- Acronym / sponsor ID
- CRISTINA / MelPRO-0322
- Conditions
- Melanoma, Skin, Melanoma Stage Iii
- Keywords
- neoadjuvant therapy, stage IIIB-D resectable melanoma, gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:
- radiological and pathological response rate to three doses of antiPD1 agents;
- do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.
After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.
Detailed description
The clinical efficacy of PD1 inhibitors on the 2-year recurrence-free survival of patients with resectable stage III B-D melanoma will be assessed. This indicator will be compared with a historical control group using adjuvant PD1 immunotherapy and targeted therapy. Various factors will be analyzed for their potential impact on immunotherapy effectiveness, including demographics, disease stage and sub-stage, molecular-genetic status of the tumor, composition of the tumor\'s lymphoid infiltrate, LDH levels, gut microbiome composition, radiological and pathological response to treatment, and the development of immune-mediated adverse events. These findings may help optimize treatment by implementing neoadjuvant therapy for stage III B-D cutaneous melanoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Gut microbiota analysisNeoadjuvant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No specific requurements to study population
Key inclusion criteria (6 listed)
- Patients aged 18 years and older.
- Performance status according to the Eastern Cooperative Oncology Group (ECOG) of 0-1.
- Patients who have not previously received immunotherapy with anti-PD1, anti-PDL1, or anti-CTLA4 agents.
- Clinical stage III (B-D), i.e., with clinically or radiologically determined metastatic changes in lymph nodes.
- Histologically confirmed involvement of regional lymph nodes.
Key exclusion criteria (7 listed)
- Patients with melanoma of non-skin localizations.
- Patients with active autoimmune diseases.
- Patients with active infectious diseases.
- Patients with severe concomitant diseases with an ECOG status \>1.
- Pregnant or lactating patients.
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 |
|---|---|---|
| Gut microbiota analysisPatients with resectable stage IIIB-D melanoma will have a lymph node core biopsy to confirm metastatic lesions, following standard procedures. Additionally, a portion of the tumor tissue will be preserved for biomarker analysis. Participants will then be instructed to submit fecal samples and complete a dietary questionnaire before receiving three doses of PD1 monotherapy, in accordance with the center\'s routine practice, typically spanning 6-10 weeks. Between weeks 10 and 12, a radiological assessment of the response will be conducted. Following this, participants will undergo regional lymphadenectomy, and the pathological response will be evaluated. After surgery, patients will be placed on adjuvant therapy for 12 months as per routine practice of the center . Subsequently, they will be monitored for five years, adhering to the institution\'s standard follow-up protocol. | Diagnostic test | Group 1 |
Primary outcome
2-year disease-free survival
Time frame: time from surgery and up to 2 years follow up
2-year disease-free survival: time from surgery to disease recurrence (either locoregional or distant) or death from any cause
1 secondary outcome
pathological response rate
Time frame: from enrollment to surgery (in average up to 20 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Undecided. IPD data could be aggregated later with another neoadjuvant study
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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?
An observational study of Melanoma, Skin and Melanoma Stage Iii, run by Russian Academy of Medical Sciences 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 7 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 8 Mar 2024. 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.
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 Igor V Samoylenko, MD (+74993249024, i.samoylenko@ronc.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease-free survival (time frame: time from surgery and up to 2 years follow up). 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 8 Mar 2024.