Clinical Stage 0 Cutaneous Melanoma AJCC v8Phase 1NCT03819296
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
A Phase 1 study testing Best Practice, Biospecimen Collection and Endoscopic Procedure in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8
- What is being tested?
- Best Practice, Biospecimen Collection and Endoscopic Procedure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2021to 31 Oct 2026
- Phase
- Phase 1
- 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
- Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
- Diagnosis of any cancer type (Projects 2 and 3)
- Treatment with any ICPI agent
- Ability to understand and willingness to sign an informed consent form and rate surveys
- Life expectancy > 4 months (Project 3)
- ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)
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- Patients with no organ toxicity as the control group (project 1)
- ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)
- ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)
- ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):
- refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,
- contraindication for immunosuppressive treatment,
- recurrence after successful initial treatment,
- recurrent symptoms once steroid is tapered down/off or diarrhea/colitis symptoms are steroid dependent, or
- 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
- No concern for active concomitant GI infection for the ICPI diarrhea/colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)
- Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment (project 3)
Who cannot join
- Age younger than 18 years
- History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
- Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
- Patients with active bacterial or fungal infection (Project 3)
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- Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3)
- Withdrawal Criteria
- Patients may withdraw from the trial at any time
- Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis
- In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Yinghong Wang, 713-563-4382, ywang59@mdanderson.org
Yinghong Wang
About this study
Official title: Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- 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:
- 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.
- 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.
- Conditions
- Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage IIA Cutaneous Melanoma AJCC v8
- Being tested
- Best Practice, Biospecimen Collection, Endoscopic Procedure, Fecal Microbiota Transplantation, Infliximab
- Medical subject headings
- Colitis, Carcinoma, Non-Small-Cell Lung, Urogenital Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Biospecimen CollectionOther
Undergo collection of stool, blood, and tissue samples
Endoscopic ProcedureProcedure or surgery
Also called Endoscopic Examination, Endoscopy
Undergo endoscopy
Fecal Microbiota TransplantationProcedure or surgery
Also called Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant
Undergo FMT
InfliximabBiological
Also called Avakine, cA2, Remicade, Remsima
Given intravenously (IV)
Laboratory Biomarker AnalysisOther
Ancillary studies
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given orally
VedolizumabBiological
Also called 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
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (standard of care, sample collection, FMT) | Experimental | 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. Receives: Other: Best Practice; Other: Biospecimen Collection; Procedure: Endoscopic Procedure; Procedure: Fecal Microbiota Transplantation; Biological: Infliximab; Other: Laboratory Biomarker Analysis; Drug: Prednisone; Biological: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 ".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start21 Feb 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage 0 Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yinghong Wang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819296
- Sponsor's protocol ID
- 2018-0383
- Other IDs
- NCI-2018-03437, 2018-0383
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2019
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population
- ClinicalTrials.gov ID
- NCT03819296
- Acronym / sponsor ID
- 2018-0383
- Conditions
- Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage IIA Cutaneous Melanoma AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Jan 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 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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (standard of care, sample collection, FMT) | Experimental | Other: Best Practice, Other: Biospecimen Collection, Procedure: Endoscopic Procedure, Procedure: Fecal Microbiota Transplantation, Biological: Infliximab, Other: Laboratory Biomarker Analysis, Drug: Prednisone, Biological: VedolizumabPROJECT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
- Diagnosis of any cancer type (Projects 2 and 3)
- Treatment with any ICPI agent
- Ability to understand and willingness to sign an informed consent form and rate surveys
- Life expectancy > 4 months (Project 3)
Key exclusion criteria (11 listed)
- Age younger than 18 years
- History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
- Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Supportive Care (standard of care, sample collection, FMT) |
| Biospecimen CollectionUndergo collection of stool, blood, and tissue samples | Other | Supportive Care (standard of care, sample collection, FMT) |
| Endoscopic ProcedureAlso: Endoscopic Examination, EndoscopyUndergo endoscopy | Procedure or surgery | Supportive Care (standard of care, sample collection, FMT) |
| Fecal Microbiota TransplantationAlso: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo TransplantUndergo FMT | Procedure or surgery | Supportive Care (standard of care, sample collection, FMT) |
| InfliximabAlso: Avakine, cA2, Remicade, RemsimaGiven intravenously (IV) | Biological | Supportive Care (standard of care, sample collection, FMT) |
| Laboratory Biomarker AnalysisAncillary studies | Other | Supportive Care (standard of care, sample collection, FMT) |
| PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven orally | Drug | Supportive Care (standard of care, sample collection, FMT) |
| VedolizumabAlso: 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-02Given IV | Biological | Supportive Care (standard of care, sample collection, FMT) |
Primary outcome
Difference in stool microbiome pattern
Time frame: Up to 1 year
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.
Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)
Time frame: Up to 1 year
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.
8 secondary outcomes
Immune profile factors associated with onset of ICPI-related colitis in blood and colon tissue
Time frame: Up to 1 year
Genetic factors associated with onset of ICPI-related colitis in blood and colon tissue
Time frame: Up to 1 year
Endoscopic and histologic features of ICPI-related colitis before and after medical treatment
Time frame: Baseline up to 1 year
Changes of ICPI-related symptoms
Time frame: Up to 1 year
Changes of quality of life (QoL)
Time frame: Up to 1 year
Cytokine features that are associated with good response to FMT
Time frame: Up to 1 year
Genetic factors associated with onset of ICPI-related colitis in blood and colon tissue
Time frame: Up to 1 year
Changes of endoscopic and histologic features of ICPI-related colitis before and after fecal microbiota transplantation
Time frame: Baseline up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Yinghong Wang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Best Practice, Biospecimen Collection and Endoscopic Procedure in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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 17 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Krishna Rajalu, MD (713-563-6086, kvaratharajalu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in stool microbiome pattern (time frame: Up to 1 year). 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?
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 15 Jul 2026.