A Phase 1 interventional study of Best Practice and Biospecimen Collection in Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8 and Clinical Stage IA Cutaneous Melanoma AJCC v8, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Supportive care
This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
PRIMARY OBJECTIVES:
I. To compare the difference in stool microbiome pattern between patients who develop immune-checkpoint inhibitor (ICPI)-related colitis and patients who don't develop ICPI-related colitis.
II. To compare the difference in stool microbiome pattern in patients who developed ICPI-related colitis before and after colitis medical treatment.
III. To assess the safety and tolerability and efficacy of fecal microbiota transplantation (FMT).
SECONDARY OBJECTIVES:
I. To identify and characterize immune profile and genetic factors associated with onset of ICPI-related colitis in blood and colon tissue.
II. To identify and characterize immune profile and genetic factors in blood and colon tissue that are associated with quick response of ICPI-related colitis to medical treatment.
III. To characterize the endoscopic and histologic features of ICPI-related colitis before and after medical treatment.
IV. To document the changes of ICPI-related symptoms and the impact on functioning and quality of life (QoL) from fecal microbiota transplantation by patient-reported outcomes (PRO).
V. To assess stool microbiome and cytokine features that are associated with good response to fecal microbiota transplantation.
VI. To assess the factors in genetic/immune profile obtained from blood and colon tissue that are associated with good response to fecal microbiota transplantation.
VII. To characterize the endoscopic and histologic features of ICPI-related colitis before and after fecal microbiota transplantation.
EXPLORATORY OBJECTIVES:
I. To identify and characterize immune profile and genetic factors associated with onset of ICPI-related colitis in inflamed colonic mucosa and its matched normal mucosa.
II. To characterize the immune profile and genetic factors from the colon tissue in these colitis patients among different histological subtypes.
III. To assess the pattern of stool microbiome that is associated with good tumor response to ICPI treatment.
IV. To assess the association between stool inflammatory markers (i.e. lactoferrin and calprotectin) and the severity of endoscopic/histologic inflammation.
V. To assess the sensitivity and specificity of stool inflammatory markers (i.e. lactoferrin and calprotectin) as an indicators of ICPI-relate colitis response to treatment.
VI. To assess the microbiome pattern that triggers the infections on immunosuppressant treatment for ICPI colitis.
OUTLINE:
PROJECT 1: Patients receive standard of care and undergo collection of stool and blood samples.
PROJECT 2: Patients receive prednisone, infliximab, or vedolizumab per standard of care and undergo standard of care endoscopy 2 months after treatment. Patients also undergo collection of stool, blood, and tissue samples.
PROJECT 3: Patients undergo fecal microbiota transplant (FMT).
After completion of study, patients are followed up periodically.
127 studies on the registry are indexed under Colitis; 31 are open to participants now.
This study's planned enrollment of 800 is above the median of 66 across 91 interventional studies indexed under Colitis.
Browse Colitis studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):
(i) to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,
(ii) for immunosuppressive treatment,
(iii) recurrence after successful initial treatment,
(iv) recurrent symptoms once steroid is tapered down/off or diarrhea/colitis symptoms are steroid dependent, or
(v) patients with a history of refractory ICPI-related colitis and/or diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT
Exclusion Criteria:
Withdrawal Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PROJECT 1: Patients receive standard of care and undergo collection of stool and blood samples. PROJECT 2: Patients receive prednisone, infliximab, or vedolizumab per standard of care and undergo standard of care endoscopy 2 months after treatment. Patients also undergo collection of stool, blood, and tissue samples. PROJECT 3: Patients undergo FMT.
Other: Best Practice · Other: Biospecimen Collection · Procedure: Endoscopic Procedure · Procedure: Fecal Microbiota Transplantation · Biological: Infliximab · Other: Laboratory Biomarker Analysis · Drug: Prednisone · Biological: Vedolizumab
Receive standard of care
Also known as: standard of care, standard therapy
Undergo collection of stool, blood, and tissue samples
Undergo endoscopy
Also known as: Endoscopic Examination, Endoscopy
Undergo FMT
Also known as: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant, Poop Transplant, Stool Transplant
Given intravenously (IV)
Also known as: Avakine, cA2, Remicade, Remsima
Ancillary studies
Given orally
Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Given IV
Also known as: Entyvio, Immunoglobulin G1, anti-(human integrin LPAM-1 (lymphocyte Peyer''s patch adhesion molecule 1)) (human-Mus musculus heavy chain), disulfide with human-Mus musculus kappa-chain, dimer, LDP 02, LDP-02, LDP02, MLN0002, MLN02
Difference in stool microbiome pattern
The primary endpoint is alpha diversity of bacteria species (measured using inverse Simpson index). It is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases.
Time frame: Up to 1 year
Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)
Adverse events will be recorded by Common Terminology Criteria for Adverse Events version 5 as well as FMT-specific events. All events will be recorded with grade and attribution to FMT. Adverse events that are related to fecal microbiota transplantation will be summarized using frequency and percentage by AE grade, type and attributions.
Time frame: Up to 1 year
Immune profile factors associated with onset of ICPI-related colitis in blood and colon tissue
Immunohistochemistry study for inflammatory markers will be performed on colon biopsies to measure the change in pattern after treatment. Blood and stool samples will be compared before and after immunosuppressive treatment longitudinally and also horizontally between quick response patients and slow/refractory patient.
Time frame: Up to 1 year
Genetic factors associated with onset of ICPI-related colitis in blood and colon tissue
Genomic bacterial DNA will be extracted from fecal samples, with the addition of a bead-beating lysis step. Genomic 16S ribosomal-RNA V4 variable region will be amplified and sequenced on the Illumina MiSeq platform to obtain the microbiome structure and composition.
Time frame: Up to 1 year
Endoscopic and histologic features of ICPI-related colitis before and after medical treatment
We will assess the resolution of the following endoscopic presentations of ICPI-related colitis including large, deep ulcerations, erosions, diffuse or patchy erythema, inflammatory exudate, loss of vascular pattern, aphthae, and edema after medical treatment. We will assess the resolution of the following histological features of acute colitis and lymphocytic colitis including neutrophilic infiltration, cryptitis, crypt abscess, eosinophilia, intraepithelial apoptosis, and increased intraepithelial lymphocytic infiltration after medical treatment.
Time frame: Baseline up to 1 year
Changes of ICPI-related symptoms
We will use MD Anderson Symptom Inventory (MDASI)-Colitis module to capture ICPI-related symptoms, which include 22 physical, psychological, and cognitive symptoms and colitis related symptoms. The ratings are on 0-10 numeric scales, ranging from "not present" to "as bad as you can imagine.
Time frame: Up to 1 year
Changes of quality of life (QoL)
MD Anderson Symptom Inventory (MDASI)-Colitis module includes 6 symptom interference items which could capture the impact of therapy on patient's physical and affective functioning. The ratings are on 0-10 numeric scales, ranging from "did not interfere " to "interfered completely ".
Time frame: Up to 1 year
Cytokine features that are associated with good response to FMT
We will compare the levels of many cytokines/chemokines by Luminex assays including IL-6, IL-17A, TNF-α, etc. between patients with good response and poor response to FMT.
Time frame: Up to 1 year
Genetic factors associated with onset of ICPI-related colitis in blood and colon tissue
Genomic bacterial DNA will be extracted from fecal samples, with the addition of a bead-beating lysis step. Genomic 16S ribosomal-RNA V4 variable region will be amplified and sequenced on the Illumina MiSeq platform to obtain the microbiome structure and composition. We will evaluate these factors between patients with good response and poor response to FMT.
Time frame: Up to 1 year
Changes of endoscopic and histologic features of ICPI-related colitis before and after fecal microbiota transplantation
We will assess the resolution of the following endoscopic presentations of ICPI-related colitis including large, deep ulcerations, erosions, diffuse or patchy erythema, inflammatory exudate, loss of vascular pattern, aphthae, and edema after FMT. We will assess the resolution of the following histological features of acute colitis and lymphocytic colitis including neutrophilic infiltration, cryptitis, crypt abscess, eosinophilia, intraepithelial apoptosis, and increased intraepithelial lymphocytic infiltration after FMT.
Time frame: Baseline up to 1 year
Started Feb 2021 (actual). Primary completion is estimated for Oct 2026, 68 months after the start.
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Studies of the drugs tested here: Infliximab · Prednisone · Vedolizumab