NCT03643289

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

5.1 years

First QC Date

August 10, 2018

Last Update Submit

February 25, 2020

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (3)

  • Gut microbiome diversity via measurement of bacterial species in stool samples

    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

    3-5 years

  • Peripheral blood monocyte measurements to determine the characterisation of peripheral blood mononuclear cells (immunophenotyping) and inflammatory markers before and after starting immunotherapy treatment.

    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.

    3-5 years

  • Side effects as determined by CTCAE scale Common Toxicity Criteria for Adverse Events v5.03

    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.

    3-5 years

Secondary Outcomes (1)

  • Analysis of optional punch biopsy samples before and after commencing immunotherapy treatment in patients with stage 4 melanoma

    3-5 years

Study Arms (2)

Cohort A

Patients with stage 4 melanoma due to commence immunotherapy. Patients should be naïve to immunotherapy.

Cohort B

Patients with stage 3 melanoma who are naïve to immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stage 3 or 4 melanoma

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

East and North Hertfordshire NHS Trust

Northwood, Middlesex, HA62RN, United Kingdom

RECRUITING

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

RECRUITING

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples, blood samples, tissue samples

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Clare Stockwell

CONTACT

02071887188 (x86754)clare.1.stockwell@kcl.ac.uk

Paul Nathan

CONTACT

0203 826 2444researchanddevelopment.enh-tr@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 22, 2018

Study Start

April 4, 2018

Primary Completion

May 2, 2023

Study Completion

May 2, 2023

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

The research results will be published in international journals and presented at scientific meetings.

Locations

GB(5)