Clinical Trials Logo
  1. Home
  2. Melanoma Stage III
  3. NCT06299878

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

Melanoma Stage Iii Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06299878
Study type Observational
Source Russian Academy of Medical Sciences
Contact Igor V Samoylenko, MD
Phone +74993249024
Email i.samoylenko@ronc.ru
Status Recruiting
Phase
Start date January 1, 2022
Completion date July 1, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04330430 - Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease Phase 2
Withdrawn NCT04007588 - A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Completed NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Recruiting NCT04562129 - IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients Phase 2
Not yet recruiting NCT05467137 - Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MSOT and ICG Phase 4
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05370807 - A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma Phase 2
Recruiting NCT04045691 - Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Recruiting NCT04513028 - Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma N/A
Completed NCT04675346 - Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors
Active, not recruiting NCT04207086 - A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma Phase 2
Completed NCT03153085 - A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma Phase 2
Recruiting NCT04741997 - Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma Early Phase 1
Active, not recruiting NCT04526899 - Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma Phase 2
Not yet recruiting NCT05827770 - The Efficacy and Safety of Neoadjuvant Toripalimab Combined With Temozolomide in Resectable Stage III Melanoma Phase 2
Recruiting NCT04598009 - Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma Phase 2
Recruiting NCT05751928 - A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma Phase 3
Recruiting NCT05402059 - Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice
Recruiting NCT05289193 - CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma Phase 2