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Melanoma Stage IVPhase 2MITRICNCT05286294

Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders

A Phase 2 study testing Fecal Microbiota Transplant (FMT) in people with Melanoma Stage IV and Head and Neck Squamous Cell Carcinoma, run by Oslo University Hospital at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-arm, single-center, open-label, phase IIa study evaluating the safety, feasibility and efficacy of Faecal Microbiota Transplant (FMT) to cancer patients not responding to ICI therapy, using ICI-responders as donors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fecal Microbiota Transplant (FMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNorway
Study dates
28 Jun 2022to 31 Dec 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be 18 years of age, at the time of signing the informed consent
  • Histologically confirmed malignant melanoma, NSCLC, CSCC, HNSCC, renal clear cell carcinoma or MSI+ solid cancer
  • Metastatic disease or local recurrence not curable by standard therapy
  • PD-L1 positivity is required for subjects with HNSCC (>20% combined positive score) and NSCLC (>20% PD-L1 expression)
  • Measurable disease according to iRECIST
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Progressive disease, as considered by the treating physician, on therapy with PD1/PD-L1 blockers and/or CTLA4-blockers and/or LAG-3 blockers, or combinations regimes comprising any of these agents. Further treatment with ICI is considered to be within standard practice.
  • Patients without any response to ICI at any time point during their disease history are eligible, without a need for re-introduction of ICI before enrollment, even if subsequent lines of anti-cancer therapy have been given. For patients with prior response to ICI, the criteria depend on the cancer form:
  • Malignant melanoma, NSCLC and MSI-H/dMMR solid cancers: Prior response to ICI is allowed only if PD under ICI has been documented <9 months before enrolment and without subsequent lines of anti-cancer therapy. For patients with prior response to ICI followed by subsequent lines of anti-cancer therapy, and patients that have not received ICI the last 9 months, ICI has to be re-introduced, and these patients have to again show progressive disease while on ICI therapy.
  • CSCC, HNSCC and renal clear cell carcinoma: Prior response to ICI is allowed, without a need for re-introduction, even if subsequent lines of anti-cancer therapy have been given, provided that disease progression has been documented under ICI therapy the last 12 months.
  • Mandatory pre-FMT biopsy and lesion accessible for further biopsies
  • Life expectancy >3 months
  • Adequate organ function as defined below:
  • Hemoglobin > 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
  • Platelet count ≥80 x 109/L
  • INR≤1.2
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).
  • AST and ALT ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN
  • Albumin >25 g/L
  • Serum creatinine ≤1.5 X ULN OR measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
  • Capable of giving signed informed consent

Who cannot join

  • Other cancer within 3 years prior to study entry, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to first FMT
  • Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters are allowed
  • Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrolment. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrolment.
  • Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to study entry, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
  • Undergone allogeneic stem cell or solid organ transplantation
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  • A positive test for HIV
  • Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HbsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Active tuberculosis
  • Ongoing immune-related adverse effects from immunotherapy treatments that are of Grade ≥2, excluding endocrine adverse effects. An ongoing grade 2 cutaneous reaction is allowed.
  • Severe infection within 14 days prior to first FMT, requiring hospitalization.
  • Any condition that significantly increases the risk of perforation during endoscopy for FMT.
  • A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation and the requirements of the trial
  • A requirement of systemic antibiotics at the time of study entry.
  • Received oral or IV antibiotics within 5 days prior to first FMT.
  • Currently receiving other study therapy that may interfere with the interpretation of data in this study.
  • Received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 10 days prior to first FMT, or anticipated requirement for systemic immunosuppressive medications during the trial. A daily dose equivalent to ≤10mg prednisolone is allowed.
  • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study.
  • Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using MRI.
  • The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
  • Pregnant or breastfeeding
  • Any reason why, in the opinion of the investigator, the patient should not participate

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, 0379

Other trials in Norway

About this study

Official title: MITRIC: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clincal Responders

This is a single-arm, single-center, open-label, phase IIa study evaluating the safety, feasibility and efficacy of Faecal Microbiota Transplant (FMT) to cancer patients not responding to ICI therapy, using ICI-responders as donors.

Read the detailed description

Immunotherapy with immune checkpoint inhibitors (ICI) has shown remarkable clinical efficacy against several cancer forms. This includes durable responses in patients with metastatic cancers and no other effective treatment options. However, many patients do not respond. This leaves a major challenge; how to turn non-responders into responders. Herein, this challenge is addressed, by attempting to modulate patients' intestinal microbiota through Faecal Microbiota Transplant (FMT). Data from several preclinical and translational studies have indicated that the microbiota composition is important for the effect of ICIs. Moreover, two recent trials exploring FMT for melanoma patients have suggested acceptable safety and a potential clinical benefit.

Being tested
Fecal Microbiota Transplant (FMT)
Keywords
Fecal microbiotal transplant (FMT), Immunotherapy
Medical subject headings
Melanoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota Transplant (FMT)Biological

    Fecal Microbiota Transplant (FMT)

Study groups in NCT05286294
Study groupRoleWhat they receive
TreatmentExperimentalFecal Microbiota Transplant (FMT)
Receives: Biological: Fecal Microbiota Transplant (FMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety evaluation of Fecal Microbiota Transplant (FMT) in advanced cancer patients

    Safety of the intervention (FMT) as assessed by the incidence, nature, and severity of Adverse Events (AE) according to NCI CTCAE, version 5.0

    Measured: 10 years

  2. Tumor response evaluation

    Objective Tumor Response Rate (ORR) as assessed by iRECIST in FAS

    Measured: 10 years

Secondary outcomes (11)

  1. Feasibility evaluation of FMT for advanced cancer patients

    The percentage of included patients that receive i) at least two FMT, ii) the scheduled number of FMT until End of Intervention (EOI)

    Measured: 10 years

  2. Overall survival (OS)

    Clinical response estimation

    Measured: 10 years

  3. Objective Tumor Response Rate (ORR)

    Clinical response estimation

    Measured: 10 years

  4. Progression Free Survival (PFS)

    Clinical response estimation

    Measured: 10 years

  5. Durable response rate (DRR)

    Clinical response estimation

    Measured: 10 years

  6. Clinical benefit range (CBR)

    Clinical response estimation

    Measured: 10 years

  7. Duration of objective response (DOR)

    Clinical response estimation

    Measured: 10 years

  8. Implant engraftment estimation, and the effect of repeated FMT

    Comparison of the patients' gut bacterial composition before and after FMT and in relation to their donors

    Measured: 10 years

  9. Evaluation of the effect of therapy on quality of life

    Patient reported outcomes (PRO) as assessed by EORTC quality of life questionnaire (QLQ-C30)

    Measured: 10 years

  10. Evaluation of the effect of therapy on fatigue

    Patient reported outcomes (PRO) as assessed by Chalder Fatigue Questionnaire (FQ)

    Measured: 10 years

  11. Evaluation of the effect of therapy on pain

    Patient reported outcomes (PRO) as assessed by an 11-point Numerical Rating Scale (NRS) for pain intensity

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start28 Jun 2022
  3. Primary completion31 Mar 2034 (estimated)
  4. Study completion31 Dec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286294
Sponsor's protocol ID
MITRIC
Acronym
MITRIC
Status last verified
Jun 2025
First submitted
1 Mar 2022
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ullern A, Garborg KK, Chauhan SK, Holm K, Bang C, Dunn C, Johnsen PH, Hov JER, Kyte JA. Safety and efficacy of fecal microbiota transplantation in solid cancers resistant to immune checkpoint inhibitors: results of the MITRIC trial. J Immunother Cancer. 2026 Jul 20;14(7):e015122. doi: 10.1136/jitc-2026-015122.

    PubMed 42476727

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal Microbiota Transplant (FMT) in people with Melanoma Stage IV and Head and Neck Squamous Cell Carcinoma, run by Oslo University Hospital at 1 site in Norway.

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 22 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation of Fecal Microbiota Transplant (FMT) in advanced cancer patients (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT05286294, 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 3 Jul 2025.

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