MelanomaNCT04107168
Microbiome Immunotherapy Toxicity and Response Evaluation
An observational study of Melanoma and Renal Cancer, run by CCTU- Cancer Theme at 13 sites in United Kingdom.
Trial summary
This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Renal Cancer, Lung Cancer
- What is being tested?
- Nivolumab, Pembrolizumab and Ipilimumab
- How many people
- 1,800 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 8 Jul 2020to 8 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 1800 cancer patients due to receive anti-PD(L)1 +/- anti-CTLA-4 antibodies for treatment of their cancer and up to 360 consenting adults (household controls) who live with one of these cancer patients.
Who may be able to join
- Signed informed consent
- 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
Who cannot join
- Other invasive malignancies diagnosed within the last year which are not fully resected, or in complete remission, or for which additional therapy is required
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites, 13 recruiting
- Recruiting
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
- Recruiting
University Hospitals Dorest NHS Foundation Trust
Bournemouth, BH7 7DW
- Recruiting
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
- Recruiting
Velindre University NHS Trust
Cardiff, CF14 2TL
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Recruiting
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn
- Recruiting
University Hospitals of Leicester NHS Foundation Trust
Leicester, LE1 5WW
- Recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
- Recruiting
Somerset NHS Foundation Trust
Taunton, TA1 5DA
- Recruiting
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ
About this study
Official title: An Observational Study to Evaluate the Microbiome as a Biomarker of Efficacy and Toxicity in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy
This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer.
Read the detailed description
The gastrointestinal microbiome of a healthy individual is comprised of many hundreds of bacteria species and thousands of bacteria strains. The composition of bacteria in an individual's microbiome can change over time and this can be influenced by factors including diet, drugs, genetics and infection. These bacteria play a central role in digestion of food, development and regulation of our immune system as well as our resistance to pathogens. Recent evidence suggest that a patient's intestinal microbiota composition plays a critical, though as yet poorly defined, role in determining both therapeutic efficacy and likelihood of significant adverse events to T-cell checkpoint inhibitor immunotherapy.
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
- Melanoma, Renal Cancer, Lung Cancer
- Being tested
- Nivolumab, Pembrolizumab, Ipilimumab, Durvalumab, Tremelimumab
- Keywords
- NSCLC, Advanced, Unresectable, Microbiome, Adjuvant, Resected, Immune checkpoint inhibitors
- Medical subject headings
- Melanoma, Kidney Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
PembrolizumabDrug
Also called Keytruda
A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
IpilimumabDrug
Also called Yervoy
A human immunoglobulin G1 (IgG1) monoclonal antibody raised against cytotoxic T lymphocyte antigen-4 (CTLA-4).
DurvalumabDrug
Also called Imfinzi
A human immunoglobulin G1-kappa (IgG1-kappa) monoclonal antibody that binds to programmed death ligand 1 (PD-L1).
TremelimumabDrug
Also called CP-675,206
A fully human monoclonal antibody raised to target cytotoxic T lymphocyte-associated antigen 4 (CTLA-4).
AtezolizumabDrug
Also called Tecentriq
A humanised IgG1 monoclonal antibody raised to target programmed death-ligand 1 (PD-L1).
BevacizumabDrug
Also called Avastin
A humanised IgG1 monoclonal antibody raised to target vascular endothelial growth factor (VEGF).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nivolumab; Drug: Pembrolizumab | |
| 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. Receives: Drug: Nivolumab; Drug: Ipilimumab | |
| 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. Receives: Drug: Nivolumab | |
| 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. Receives: Drug: Nivolumab; Drug: Ipilimumab | |
| 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. Receives: Drug: Nivolumab; Drug: Pembrolizumab; Drug: Atezolizumab | |
| 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. Receives: Drug: Nivolumab; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Bevacizumab | |
| 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. Receives: Drug: Nivolumab; Drug: Pembrolizumab | |
| 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. Receives: Drug: Pembrolizumab; Drug: Durvalumab | |
| 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. Receives: Drug: Durvalumab; Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can the microbiome signature predict progression-free survival (PFS) of 1 year or greater
The primary outcome measure is the ability to predict for PFS of 1 year or greater for patients with advanced melanoma, renal and non-small cell lung cancer (cohorts 1-6).
Measured: Minimum 1 year PFS
Secondary outcomes (8)
Can the microbiome signature predict PFS
Measure the ability of the microbiome signature to predict 6 month PFS, 2 year PFS, overall response rate and median PFS in Cohorts 1-6.
Measured: 1 year & 2 years PFS
Can the microbiome signature overall survival (OS)
Measure the ability of the microbiome signature to median OS in Cohorts 1-6.
Measured: Up to 6 years
Can the microbiome signature to predict relapse
Measure the ability of the microbiome signature to predict for 1 or 2 year relapse after resection of high risk melanoma or renal cancer in cohorts 7-9.
Measured: 1 year & 2 years relapse-free survival (RFS)
Does the microbiome correlate with treatment efficacy
To compare pre-treatment oral and gut microbiome findings and their association with treatment efficacy.
Measured: Up to 6 years
Correlate microbiome findings with incidence and characteristics of immune-related adverse events
To correlate microbiome findings with incidence and characteristics of CTCAE V5-defined Grade 3 or greater immune-related adverse events in all enrolled cancer patients, and any association with response to immunosuppressants.
Measured: Up to 6 years
Correlation microbiome findings and known characteristics of patients
To correlate microbiome findings with aspects of pre-existing patient characteristics and behaviour including but not limited to diet, smoking history, BMI, use of antibiotics, steroids, proton pump inhibitors, non-steroidal anti-inflammatory drugs and probiotics.
Measured: Up to 6 years
Control for the microbiome of cancer patients
To compare the microbiome signature of cancer patients with a household control group of people who are not known to have cancer.
Measured: Up to 6 years
Build a library of biological samples for future research
To retain a library of biological samples (saliva, stool, blood and tumour as well as organ if available) with linked patient data for future research.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start8 Jul 2020
- Primary completion8 Jul 2024 (estimated)
- Study completion8 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- Microbiotica Ltd
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Pippa Corrie, Principal investigator, Cambridge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107168
- Sponsor's protocol ID
- MITRE
- Other IDs
- C7535/A27717
- Status last verified
- Feb 2023
- First submitted
- 9 Sep 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35073853
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Microbiome as a Biomarker of Efficacy and Toxicity in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT04107168
- Acronym / sponsor ID
- MITRE
- Conditions
- Melanoma, Renal Cancer, Lung Cancer
- Keywords
- NSCLC, Advanced, Unresectable, Microbiome, Adjuvant, Resected, Immune checkpoint inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- Microbiotica Ltd
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 8 Jul 2024 (estimated)
- Study completion
- 8 Jul 2025 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer.
Detailed description
The gastrointestinal microbiome of a healthy individual is comprised of many hundreds of bacteria species and thousands of bacteria strains. The composition of bacteria in an individual's microbiome can change over time and this can be influenced by factors including diet, drugs, genetics and infection. These bacteria play a central role in digestion of food, development and regulation of our immune system as well as our resistance to pathogens. Recent evidence suggest that a patient's intestinal microbiota composition plays a critical, though as yet poorly defined, role in determining both therapeutic efficacy and likelihood of significant adverse events to T-cell checkpoint inhibitor immunotherapy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Nivolumab, Drug: PembrolizumabDisease: 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. |
| Cohort 2 | – | Drug: Nivolumab, Drug: IpilimumabDisease: 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. |
| Cohort 3 | – | Drug: NivolumabDisease: 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. |
| Cohort 4 | – | Drug: Nivolumab, Drug: IpilimumabDisease: 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. |
| Cohort 5 | – | Drug: Nivolumab, Drug: Pembrolizumab, Drug: AtezolizumabDisease: 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. |
| Cohort 6 | – | Drug: Nivolumab, Drug: Pembrolizumab, Drug: Atezolizumab, Drug: BevacizumabDisease: 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. |
| Cohort 7 | – | Drug: Nivolumab, Drug: PembrolizumabDisease: 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. |
| Cohort 8 | – | Drug: Pembrolizumab, Drug: DurvalumabDisease: 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. |
| Cohort 9 | – | Drug: Durvalumab, Drug: TremelimumabDisease: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 1800 cancer patients due to receive anti-PD(L)1 +/- anti-CTLA-4 antibodies for treatment of their cancer and up to 360 consenting adults (household controls) who live with one of these cancer patients.
Key inclusion criteria (7 listed)
- Signed informed consent
Key exclusion criteria (24 listed)
- Other invasive malignancies diagnosed within the last year which are not fully resected, or in complete remission, or for which additional therapy is required
- 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:
- 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.
- Confirmation of suitability to be a household control participant will be determined by completing a self-assessed questionnaire either at home or in clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoA human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| PembrolizumabAlso: KeytrudaA human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1. | Drug | Cohort 1, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| IpilimumabAlso: YervoyA human immunoglobulin G1 (IgG1) monoclonal antibody raised against cytotoxic T lymphocyte antigen-4 (CTLA-4). | Drug | Cohort 2, Cohort 4 |
| DurvalumabAlso: ImfinziA human immunoglobulin G1-kappa (IgG1-kappa) monoclonal antibody that binds to programmed death ligand 1 (PD-L1). | Drug | Cohort 8, Cohort 9 |
| TremelimumabAlso: CP-675,206A fully human monoclonal antibody raised to target cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). | Drug | Cohort 9 |
| AtezolizumabAlso: TecentriqA humanised IgG1 monoclonal antibody raised to target programmed death-ligand 1 (PD-L1). | Drug | Cohort 5, Cohort 6 |
| BevacizumabAlso: AvastinA humanised IgG1 monoclonal antibody raised to target vascular endothelial growth factor (VEGF). | Drug | Cohort 6 |
Primary outcome
Can the microbiome signature predict progression-free survival (PFS) of 1 year or greater
Time frame: Minimum 1 year PFS
The primary outcome measure is the ability to predict for PFS of 1 year or greater for patients with advanced melanoma, renal and non-small cell lung cancer (cohorts 1-6).
8 secondary outcomes
Can the microbiome signature predict PFS
Time frame: 1 year & 2 years PFS
Can the microbiome signature overall survival (OS)
Time frame: Up to 6 years
Can the microbiome signature to predict relapse
Time frame: 1 year & 2 years relapse-free survival (RFS)
Does the microbiome correlate with treatment efficacy
Time frame: Up to 6 years
Correlate microbiome findings with incidence and characteristics of immune-related adverse events
Time frame: Up to 6 years
Correlation microbiome findings and known characteristics of patients
Time frame: Up to 6 years
Control for the microbiome of cancer patients
Time frame: Up to 6 years
Build a library of biological samples for future research
Time frame: Up to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 35073853Thompson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pippa Corrie principal investigator
Cambridge University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Renal Cancer, run by CCTU- Cancer Theme at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MITRE Study Coordinator (01223 274746, cuh.mitre@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can the microbiome signature predict progression-free survival (PFS) of 1 year or greater (time frame: Minimum 1 year PFS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.