Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299878
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-23
Brief Title:
MelPRO-0322 CRISTINA Trial miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns
Sponsor:
Russian Academy of Medical Sciences
Organization:
Russian Academy of Medical Sciences
Study Overview
Official Title:
Neoadjuvant Monotherapy With Anti-PD1 Agents in Patients With Resectable Stage IIIB-D Melanoma Analysis of Novel Biomarkers
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRISTINA
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
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 tumor39s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None