Microbiome Immunotherapy Toxicity and Response Evaluation

  • End date
    Jul 8, 2025
  • participants needed
  • sponsor
    CCTU- Cancer Theme
Updated on 10 December 2021
monoclonal antibodies
systemic therapy
measurable disease
cancer treatment
vascular endothelial growth factor
immune checkpoint inhibitor
lymphocyte antigen
immunologic adjuvant
cytotoxic t-lymphocyte antigen 4
Accepts healthy volunteers


This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer.


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.

Condition urinary tract neoplasm, Nephropathy, Pulmonary Disease, Bronchial Neoplasm, skin cancer, carcinoma lung, Lung Disease, Malignant neoplasm of kidney, Lung Neoplasm, Lung Cancer, Renal Cancer, Urologic Cancer, Malignant Melanoma, Skin Cancer, Kidney Disease (Pediatric), melanoma, cancer, renal, Kidney Disease, Melanoma, lung carcinoma, Metastatic Melanoma, Kidney Cancer
Treatment Ipilimumab, bevacizumab, Pembrolizumab, tremelimumab, Nivolumab, durvalumab, Atezolizumab
Clinical Study IdentifierNCT04107168
SponsorCCTU- Cancer Theme
Last Modified on10 December 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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
In addition, household controls must sign informed consent and be aged 18
NOT had requirement to be hospitalised for treatment of COVID-19
years old
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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