Neoadjuvant Monotherapy With Anti-PD1 Agents in Patients With Resectable Stage IIIB-D Melanoma: Analysis of Novel Biomarkers

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
N.N. Blokhin Russian Cancer Research Center, skin tumor department
RECRUITING
Moscow
Contact Information
Primary
Igor V Samoylenko, MD
i.samoylenko@ronc.ru
+74993249024
Backup
Angelina O Kuzmenko, MD
angelin.kuzmenko@gmail.com
+74993249024
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 72
Treatments
Group 1
Neoadjuvant
Related Therapeutic Areas
Sponsors
Leads: Russian Academy of Medical Sciences

This content was sourced from clinicaltrials.gov