MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

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MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06299878
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Russian Academy of Medical Sciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Skin, Melanoma Stage Iii

Additional Details

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.

Arms & Interventions

Arms

: Group 1

Neoadjuvant

Interventions

Diagnostic Test: - Gut microbiota analysis

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.

Contact a Trial Team

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