Clinical trial · Observational
Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate the effects of gut microbiome diversity (richness in terms of many bacterial species in the gut) on responses and side effects of immunotherapy in advanced melanoma patients. Immunotherapy for melanoma is especially damaging for the gut with colitis which can lead to death and significant morbidity with repeated hospital admissions. The richness of the microbiome in the gut may be protective against colitis and other side effects but this needs to be confirmed. There is also some preliminary evidence that the gut microbiome diversity can enhance responses to immunotherapy in cancer but this has been shown in small numbers of melanoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Patients with stage 4 melanoma due to commence immunotherapy. Patients should be naïve to immunotherapy.
- label
- Cohort B
- description
- Patients with stage 3 melanoma who are naïve to immunotherapy
Primary outcomes (3)
- measure
- Gut microbiome diversity via measurement of bacterial species in stool samples
- timeFrame
- 3-5 years
- description
- Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in patients with stage 3 or stage 4 melanoma receiving immunotherapy
- measure
- Peripheral blood monocyte measurements to determine the characterisation of peripheral blood mononuclear cells (immunophenotyping) and inflammatory markers before and after starting immunotherapy treatment.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients aged over the age of 18 years with advanced melanoma due to receive first line systemic treatment with immunotherapy with a checkpoint inhibitor alone or in combination. Exclusion Criteria: * Patients who have had systemic anti-cancer treatment for locally advanced or metastatic disease. * Patients unable to consent because of language barrier or inability to consent. * Patients unable to collect or send the stool samples for geographical, social or psychological reasons. * Persons benefitting from protection system of adults (including guardianship and curatorship) * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available