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

Launched by RUSSIAN ACADEMY OF MEDICAL SCIENCES · Mar 1, 2024

Keywords

ClinConnect Summary

The CRISTINA Trial, also known as MelPRO-0322, is studying how certain markers in the body, like gut bacteria and specific traits of melanoma, can help predict how well patients with advanced melanoma will respond to a treatment called anti-PD1 therapy. This trial is particularly focused on patients with stage IIIB-D melanoma, which means the cancer has spread to nearby lymph nodes. Participants will receive three doses of this treatment and will have surgery to remove affected lymph nodes. Before starting the treatment, they will provide stool samples and fill out a dietary questionnaire to help researchers understand the connection between their gut health and treatment response.

To take part in this study, participants need to be at least 18 years old and have not received certain prior immunotherapies. They should have specific types of melanoma that can be measured during the study. Those with active autoimmune diseases, infections, or other serious health conditions are not eligible. After the initial treatment and surgery, participants may receive additional therapy for a year and will be monitored for five years to track their health and any changes. This trial aims to uncover important information that could improve future treatment strategies for melanoma patients.

Gender

ALL

Eligibility 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.