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

NCT06299878 | Recruiting

• 1 other identifier: MelPRO-0322
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Melanoma, Skin; Melanoma Stage Iii

Keywords

neoadjuvant therapy; stage IIIB-D resectable melanoma; gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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

  time from surgery and up to 2 years follow up

Secondary Outcomes (1)

• pathological response rate

  from enrollment to surgery (in average up to 20 weeks)

Other Outcomes (1)

• biomarker reproducibility

  from enrollment to end of the study follow up (in average during 6 months since randomization)

Study Arms (1)

Group 1

Neoadjuvant

Diagnostic Test: Gut microbiota analysis

Interventions

Gut microbiota analysis DIAGNOSTIC_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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

No specific requurements to study population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (1)

N.N. Blokhin Russian Cancer Research Center, skin tumor department

Moscow, 115478, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

formalin fixed paraffin embedded tissue tumor blocks faeces

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Igor V Samoylenko, MD

CONTACT

+74993249024; i.samoylenko@ronc.ru

Angelina O Kuzmenko, MD

CONTACT

+74993249024; angelin.kuzmenko@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, MD, PhD

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 8, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

RU (1)