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Evaluating the role of the microbiome in cancer treatment response and toxicity

An Observational Study to Evaluate the Microbiome as a Biomarker of Efficacy and Toxicity in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy

Observational Cambridge University Hospitals NHS Foundation Trust · NCT04107168

This study looks at how the bacteria in your gut might affect how well immune treatments work and their side effects for people with advanced cancers like melanoma, kidney cancer, and lung cancer.

Quick facts

Study typeObservational
Enrollment1800 (estimated)
Ages18 Years and up
SexAll
SponsorCambridge University Hospitals NHS Foundation Trust Academic / other
Drugs / interventionsimmunotherapy
Locations13 sites (Bath and 12 other locations)
Trial IDNCT04107168 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between the gastrointestinal microbiome and the efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancers such as melanoma, renal cancer, and lung cancer. Researchers will collect saliva and stool samples from participants to analyze their microbiome composition and link this data to treatment responses and adverse events. The goal is to understand how microbiome biomarkers can help personalize immunotherapy treatments for better patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced melanoma, renal cancer, or lung cancer who are about to start treatment with immune checkpoint inhibitors.

Not a fit: Patients who have previously received immune checkpoint inhibitors or those with resectable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized immunotherapy approaches that improve treatment efficacy and reduce adverse effects for cancer patients.

How similar studies have performed: Other studies have shown promising results in understanding the microbiome's impact on immunotherapy, suggesting this approach has potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria for cancer patients:

* 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 for cancer patients:

* 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 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.

Where this trial is running

Bath and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaRenal CancerLung CancerNSCLCAdvancedUnresectableMicrobiomeAdjuvant
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.