Predicting melanoma treatment response using gut microbiota analysis
Neoadjuvant Monotherapy With Anti-PD1 Agents in Patients With Resectable Stage IIIB-D Melanoma: Analysis of Novel Biomarkers
This study is testing if the bacteria in your gut can help predict how well people with advanced melanoma will respond to a specific cancer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Russian Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy, prednisone |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06299878 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if gut microbiota and molecular genetic features can predict the response to neoadjuvant therapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. Participants will receive three doses of anti-PD1 monotherapy and undergo regional lymphadenectomy, with their gut microbiota analyzed through fecal samples and dietary questionnaires. The study will assess the correlation between treatment responses and various factors, including demographics and tumor characteristics, over a follow-up period of five years.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with resectable stage III B-D melanoma who have not previously received immunotherapy.
Not a fit: Patients with melanoma in non-skin locations or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for melanoma patients based on their gut microbiota composition.
How similar studies have performed: While the approach of using gut microbiota to predict treatment response is emerging, this specific methodology remains novel and largely untested in the context of melanoma.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Moscow
- N.N. Blokhin Russian Cancer Research Center, skin tumor department — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Igor V Samoylenko, MD
- Email: i.samoylenko@ronc.ru
- Phone: +74993249024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.