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Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics

NCT03643289 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2020-02-27

No results posted yet for this study

Summary

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

  • Melanoma (Skin)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2023-05-02
Completion
2023-05-02

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643289 on ClinicalTrials.gov