Microbiome Immunotherapy Toxicity and Response Evaluation
NCT ID: NCT04107168
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1800 participants
OBSERVATIONAL
2020-07-08
2025-07-08
Brief Summary
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Detailed Description
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Immune checkpoint inhibitors are revolutionising treatment of many types of metastatic cancer, including melanoma, renal and non-small cell lung cancer, in the expectation of improving patient overall survival. However, they have limitations as they do not work for all patients and can cause unpredictable, complex immune-related toxicities. The investigators will perform a detailed study of cancer patients receiving checkpoint inhibitors. Saliva and a series of stool samples will be collected from each patient to analyse their microbiome and will be linked to treatment response, by examining blood samples and - if available - tumour and organ samples. The investigators hope this work will enable personalisation of patient immunotherapies based on microbiome biomarkers, as well as precisely manipulate a patient's microbiota to optimise their immunotherapy.
In addition, participants who have consented to take part in an optional sub-study may be offered a single nasopharyngeal swab for COVID-19 antigen before study entry. The investigators hope that that this identify correlations between the microbiome and COVID-19.
Comparison with a limited cohort of healthy household members (up to 360 volunteers) acting as controls will provide additional essential information about the role of the patient-specific microbiome.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Disease: Unresectable AJCC (American Joint Committee on Cancer) stage 3 or 4 melanoma.
Anti-PD-1 monotherapy (Nivolumab or Pembrolizumab). Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Pembrolizumab
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
Cohort 2
Disease: Unresectable AJCC stage 3 or 4 melanoma. Nivolumab + Ipilimumab. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Ipilimumab
A human immunoglobulin G1 (IgG1) monoclonal antibody raised against cytotoxic T lymphocyte antigen-4 (CTLA-4).
Cohort 3
Disease: Advanced renal cell carcinoma. Anti-PD-(L)1 + kinase inhibitor. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Cohort 4
Disease: Advanced renal cell carcinoma Nivolumab + Ipilimumab. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Ipilimumab
A human immunoglobulin G1 (IgG1) monoclonal antibody raised against cytotoxic T lymphocyte antigen-4 (CTLA-4).
Cohort 5
Disease: Advanced NSCLC Anti-PD-(L)1 (Nivolumab, Pembrolizumab or Atezolizumab) monotherapy in the first line setting. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Pembrolizumab
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
Atezolizumab
A humanised IgG1 monoclonal antibody raised to target programmed death-ligand 1 (PD-L1).
Cohort 6
Disease: Advanced NSCLC Anti-PD-(L)1 (Nivolumab, Pembrolizumab or Atezolizumab) + chemotherapy +/- antiangiogenic (Bevacizumab) in the first line setting. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Pembrolizumab
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
Atezolizumab
A humanised IgG1 monoclonal antibody raised to target programmed death-ligand 1 (PD-L1).
Bevacizumab
A humanised IgG1 monoclonal antibody raised to target vascular endothelial growth factor (VEGF).
Cohort 7
Disease: Resected AJCC stage 3 or 4 melanoma. Anti-PD-1 monotherapy (Nivolumab or Pembrolizumab). Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Pembrolizumab
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
Cohort 8
Disease: Resected renal cancer Anti-PD-(L)1 monotherapy (Durvalumab or Pembrolizumab). Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Pembrolizumab
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
Durvalumab
A human immunoglobulin G1-kappa (IgG1-kappa) monoclonal antibody that binds to programmed death ligand 1 (PD-L1).
Cohort 9
Disease: Resected renal cancer Durvalumab + Tremelimumab. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Durvalumab
A human immunoglobulin G1-kappa (IgG1-kappa) monoclonal antibody that binds to programmed death ligand 1 (PD-L1).
Tremelimumab
A fully human monoclonal antibody raised to target cytotoxic T lymphocyte-associated antigen 4 (CTLA-4).
Interventions
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Nivolumab
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
Pembrolizumab
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
Ipilimumab
A human immunoglobulin G1 (IgG1) monoclonal antibody raised against cytotoxic T lymphocyte antigen-4 (CTLA-4).
Durvalumab
A human immunoglobulin G1-kappa (IgG1-kappa) monoclonal antibody that binds to programmed death ligand 1 (PD-L1).
Tremelimumab
A fully human monoclonal antibody raised to target cytotoxic T lymphocyte-associated antigen 4 (CTLA-4).
Atezolizumab
A humanised IgG1 monoclonal antibody raised to target programmed death-ligand 1 (PD-L1).
Bevacizumab
A humanised IgG1 monoclonal antibody raised to target vascular endothelial growth factor (VEGF).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged ≥18 years old
* Histological or cytological confirmation of invasive malignancy
* Due to commence palliative, adjuvant or neoadjuvant systemic therapy including an anti-PD-(L)1 antibody +/- anti-CTLA-4 antibody
* Patients with unresectable disease must have radiologically and/or clinically measurable disease, by RECIST version 1.1; target lesions must not have been previously irradiated; baseline tumour assessments must be performed within 45 days prior to starting immune checkpoint inhibitor treatment
* Received no prior immune checkpoint inhibitors (previous treatment with other types of anti-cancer therapy is determined by patient cohort; for patients with unresectable disease, prior adjuvant therapy with immune checkpoint inhibitor(s) is allowed).
* Willing and able to comply with scheduled visits, treatment plans, sample collections and other study procedures
Exclusion Criteria
* Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk, or interfere with their ability to comply with the study. Examples may include, but are not limited to:
* Patients with uncontrolled ischaemic heart or other cardiovascular event (e.g. myocardial infarction, new angina, stroke, transient ischaemic attack, or new congestive cardiac failure) within the last 6 months
* Presence of active infection
* Cirrhotic liver disease, known chronic active or acute hepatitis B, or hepatitis C
* Current active, severe, or uncontrolled autoimmune condition, including but not limited to Crohn's disease and ulcerative colitis.
* Women who are pregnant, plan to become pregnant or are lactating during the study period.
* Requirement for non-physiological dose of oral steroids, or regular use of any other immunosuppressive agents; less than 10mg prednisolone or equivalent doses are allowed. Use of inhaled or topical steroids is allowed.
Household control eligibility requirements:
Confirmation of suitability to be a household control participant will be determined by completing a self-assessed questionnaire either at home or in clinic.
Household controls must:
* NOT have had any gastrointestinal infections i.e., parasites, viruses or diarrhoeal episodes during the last 6 months.
* NOT have taken antibiotics for at least 6 months
* NOT have or be recovering from any chronic intestinal disease such as:
* Crohn's disease
* Ulcerative colitis
* Coeliac disease
* Irritable bowel syndrome
* Stomach ulcers
* NOT have a chronic autoimmune disease or significant allergies e.g., multiple sclerosis, asthma requiring regular medication, psoriasis.
* NOT have and NOT be recovering from any form of cancer.
* NOT take proton pump inhibitors, steroids, other non-steroidal anti-inflammatory drugs such as ibuprofen or aspirin.
* NOT had requirement to be hospitalised for treatment of COVID-19
In addition, household controls must sign informed consent and be aged ≥18 years old.
18 Years
ALL
Yes
Sponsors
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Microbiotica Ltd
INDUSTRY
CCTU- Cancer Theme
OTHER
Responsible Party
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CCTU- Cancer Theme
Dr Pippa Corrie, Chief Investigator
Principal Investigators
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Pippa Corrie
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospital
Locations
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Royal United Hospitals Bath NHS Foundation Trust
Bath, , United Kingdom
University Hospitals Dorest NHS Foundation Trust
Bournemouth, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Velindre University NHS Trust
Cardiff, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn, , United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Somerset NHS Foundation Trust
Taunton, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
Countries
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Central Contacts
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References
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Thompson NA, Stewart GD, Welsh SJ, Doherty GJ, Robinson MJ, Neville BA, Vervier K, Harris SR, Adams DJ, Dalchau K, Bruce D, Demiris N, Lawley TD, Corrie PG. The MITRE trial protocol: a study to evaluate the microbiome as a biomarker of efficacy and toxicity in cancer patients receiving immune checkpoint inhibitor therapy. BMC Cancer. 2022 Jan 24;22(1):99. doi: 10.1186/s12885-021-09156-x.
Other Identifiers
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C7535/A27717
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MITRE
Identifier Type: -
Identifier Source: org_study_id
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