A Phase 2 interventional study of Fecal Microbiota Transplant with Pembrolizumab in Melanoma, sponsored by Zarour, Hassane, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Zarour, Hassane, MD · Phase 2, Interventional, and Treatment
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Among 2,048 studies in Melanoma with a site in United States — 243 open to participants now, 439 under way, 32 of them phase 3. Melanoma · United States.
Among the 2,048 studies in Melanoma with a site in United States, this one is the 1,181st largest by enrollment of the 1,748 interventional ones that give a count, is one of 97 that started in 2018, is one of 612 in phase 2, and was the 1,317th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →243 of the 2,048 studies in Melanoma with a site in United States are open now. Recruiting first, the newest first:
Children's Oncology Group · Sites in United States
Ages up to 25
John Kirkwood · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18+
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
Ages 18+ · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 55+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,048 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 934 · Phase 2 907 · Phase 3 115 · Phase 4 11
First in 1991; this study’s year is marked. 97 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 37 across the 1,748 interventional studies, 156 across the 212 observational. Of the 1,481 that completed or were terminated, 598 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
799 of 2,048 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Zarour, Hassane, MD as lead sponsor.
Zarour, Hassane, MD has 1 study filed under Melanoma — fewer than ten, so there is no comparison to draw.
141 of the studies in Melanoma with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT05987332Phase 3IDEAYA BiosciencesIDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma | 2027-01-15 |
| NCT06246916Phase 3Regeneron PharmaceuticalsA Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | 2027-03-22 |
| NCT01223248Phase 3Memorial Sloan Kettering Cancer CenterRandomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy | 2027-10 |
| NCT06112314Phase 3Immunocore LtdIMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) | 2027-10-16 |
Add all 141 to your calendar (.ics) → With an account.
Among the 2,048 studies in Melanoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The main goal of this research study is to determine if the fecal microbiota transplant (FMT) improves the body's ability to fight your cancer.
This is a phase II Simon two-stage single-center study of concurrent fecal microbiota transplant (FMT) with pembrolizumab in patients with PD-1 resistant/refractory melanoma. The study will be conducted over a 12-week period (and up to 24-weeks in responding patients).
Patient eligibility is based upon prior exposure to PD-1 inhibitor therapy and response at first (or subsequent) restaging scans from week 12 up to week 52. Patients must have received a minimum of 2 cycles to be considered eligible. Patients who have received either nivolumab or pembrolizumab are eligible. Patients who have received pembrolizumab/nivolumab in combination with other investigational agent(s) may be eligible at the discretion of the treating investigator. PD-1 refractory disease is defined as progressive disease (PD) at the first (or subsequent) radiographic evaluation while receiving PD-1 inhibitor treatment as assessed by RECIST v1.1 on a restaging scan. Other eligibility criteria include absence of CNS disease, presence of disease amenable to biopsy and lack of contra-indications to FMT administration. Patients will be stratified on the presence or absence of liver metastases.
Suitable patients will be identified following first (or subsequent) restaging study that documents progressive disease (RECIST v1.1). Patients will undergo a screening evaluation consisting of imaging (including CNS if clinically suspected), tumor biopsy, and serological/stool studies to confirm suitability for FMT administration. Eligible patients will receive FMT endoscopically (along with intestinal biopsy) (with cycle 1 pembrolizumab +/- 3 days) followed by 3 further cycles of pembrolizumab (cycles 2-4) following which restaging will be performed. Patients with stable and/or responding disease will continue to receive pembrolizumab on study for 4 cycles. Patients with stable and/or responding disease after 8 cycles of pembrolizumab will continue to receive therapy off study until disease progression or up to two years from FMT administration.
In August of 2026 the outcome measures were updated clarify the specific analyses that were performed in accordance with the stated protocol endpoints. The "Change in T-Cells Composition", "Change in Innate/Adaptive Immune System Subsets", and "Function of T-Cells" outcome measures were removed. These were replaced with the more specific outcomes: "Change in CD8+CD56+ T Cells", "Change in [TIGIT/LAG-3/CD27/Tbet] Expression in CD8+ T Cells", and "Change in Prevalence of [Naive/EM/CM/TEMRA] CD8+ T Cells" outcome measures.
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.
(ANC) ≥1,500 /mcL ≥100,000 / mcL ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Serum creatinine OR Measured or calculateda ( can also be used in place of creatinine or CrCl) - ≤1.5 X (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Serum total ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases Albumin >2.5 mg/dL (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
Exclusion Criteria:
- Presence of absolute to FMT administration: Toxic megacolon Severe dietary allergies (e.g. shellfish, nuts, seafood) Inflammatory bowel disease Anatomic contra-indications to colonoscopy
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes. Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Drug: Fecal Microbiota Transplant with Pembrolizumab
FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1. Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Objective Response Rate (ORR)
Number of patients with patients with objective responses (Complete Response (CR) + Partial Response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to 3 years
Disease Control Rate (DCR)
Number of patients with patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Up to 3 years
Incidence of Grade III/IV Toxicities
Number of patients who experienced grade III or grade IV toxicities per CTCAE v5.0, related to study treatment.
Time frame: Up to 4 years
Progression-free Survival (PFS)
Time from first response to to treatment until documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame: Up to 4 years
6-month Progression-free Survival (PFS)
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 6 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame: At 6 months
12-month Progression-free Survival (PFS)
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 12 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame: At 12 months
24-month Progression-free Survival (PFS)
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 24 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame: At 24 months
Overall Survival (OS)
Overall survival (OS), defined as time from first dose of study treatment until death due to any cause.
Time frame: Up to 6.5 years
6-month Overall Survival (OS)
Percentage of patients alive at 6 months from first dose of study treatment.
Time frame: At 6 months
12-month Overall Survival (OS)
Percentage of patients alive at 12 months from first dose of study treatment.
Time frame: At 12 months
24-month Overall Survival (OS)
Percentage of patients alive at 24 months from first dose of study treatment.
Time frame: At 24 months
Change in CD8+CD56+ T Cells
Change in cytolytic CD8+CD56+ T cell frequency (as a percentage of all PBMCs) at Day 0, 21, and 42 of treatment. Results will be broken down by response status (responders vs. non-responders).
Time frame: Day 0, Day 21, and Day 42
Change in TIGIT Expression in CD8+ T Cells
TIGIT expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower TIGIT expression relative to the batch mean.
Time frame: Day 0, Day 21, and Day 42
Change in LAG-3 Expression in CD8+ T Cells
LAG-3 expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower LAG-3 expression relative to the batch mean.
Time frame: Day 0, Day 21, and Day 42
Change in CD27 Expression in CD8+ T Cells
CD27 expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower CD27 expression relative to the batch mean.
Time frame: Day 0, Day 21, and Day 42
Change in Tbet Expression in CD8+ T Cells
Tbet expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower Tbet expression relative to the batch mean.
Time frame: Day 0, Day 21, and Day 42
Change in Prevalence of Naive CD8+ T Cells
Change in prevalence of naive CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
Time frame: Day 0, Day 21, and Day 42
Change in Prevalence of Effector Memory (EM) CD8+ T Cells
Change in prevalence of Effector Memory (EM) CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
Time frame: Day 0, Day 21, and Day 42
Change in Prevalence of Central Memory (CM) CD8+ T Cells
Change in prevalence of Central Memory (CM) CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
Time frame: Day 0, Day 21, and Day 42
Change in Prevalence of Terminally Differentiated Effector Memory (TEMRA) CD8+ T Cells
Change in prevalence of Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
Time frame: Day 0, Day 21, and Day 42
Association of PD-1 Response With (Common) Gut Microbiota
Changes in bacterial abundance (quantified by the operational taxonomic unit (OTU)) which indicates the number of different species present along with the representative proportion of each species in the sample) and bacterial diversity (quantified by alpha diversity which is defined by the Shannon Index and quantifies both the organismal richness of a sample and the evenness of the organisms' abundance distribution), between pre- and post- treatment samples from patients that respond and patients that do not respond (per RECIST 1.1) to study treatment.
Time frame: 4 years
| Milestone | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Number of patients with patients with objective responses (Complete Response (CR) + Partial Response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Partial Response | 2 |
| Progressive Disease | 1 |
Number of patients with patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
| Participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Partial Response (PR) | 2 |
| Stable Disease (SD) | 10 |
| Complete Response (CR) | 1 |
Number of patients who experienced grade III or grade IV toxicities per CTCAE v5.0, related to study treatment.
| Participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Atrial fibrillation | 1 |
| Lymphocyte count decreased | 1 |
| Arthralgia | 1 |
| Myopathy | 1 |
| Hyponatremia | 2 |
Time from first response to to treatment until documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
| months | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Progression-free Survival (PFS) | 9 (3 to 32) |
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 6 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
| percentage of participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| 6-month Progression-free Survival (PFS) | 61 (35 to 79) |
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 12 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
| percentage of participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| 12-month Progression-free Survival (PFS) | 34 (13 to 57) |
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 24 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
| percentage of participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| 24-month Progression-free Survival (PFS) | 34 (13 to 57) |
Overall survival (OS), defined as time from first dose of study treatment until death due to any cause.
| months | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Overall Survival (OS) | 34 (6 to NA) |
Percentage of patients alive at 6 months from first dose of study treatment.
| percentage of participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| 6-month Overall Survival (OS) | 75 (49 to 89) |
Percentage of patients alive at 12 months from first dose of study treatment.
| percentage of participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| 12-month Overall Survival (OS) | 64 (39 to 81) |
Percentage of patients alive at 24 months from first dose of study treatment.
| percentage of participants | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| 24-month Overall Survival (OS) | 64 (39 to 81) |
Changes in bacterial abundance (quantified by the operational taxonomic unit (OTU)) which indicates the number of different species present along with the representative proportion of each species in the sample) and bacterial diversity (quantified by alpha diversity which is defined by the Shannon Index and quantifies both the organismal richness of a sample and the evenness of the organisms' abundance distribution), between pre- and post- treatment samples from patients that respond and patients that do not respond (per RECIST 1.1) to study treatment.
Results for this outcome have not been posted.
Change in cytolytic CD8+CD56+ T cell frequency (as a percentage of all PBMCs) at Day 0, 21, and 42 of treatment. Results will be broken down by response status (responders vs. non-responders).
| Percentage of PBMCs | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 1.170 ± 0.831 | 0.984 ± 0.728 |
| Day 21 | 1.409 ± 1.069 | 0.764 ± 0.399 |
| Day 42 | 2.876 ± 2.878 | 0.614 ± 0.340 |
TIGIT expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower TIGIT expression relative to the batch mean.
| Z-Score of Fluorescence Intensity | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 0.088 ± 0.779 | -0.619 ± 0.921 |
| Day 21 | 0.564 ± 0.318 | -0.559 ± 0.950 |
| Day 42 | -0.218 ± 0.667 | -0.355 ± 1.020 |
LAG-3 expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower LAG-3 expression relative to the batch mean.
| Z-Score of Fluorescence Intensity | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 0.163 ± 0.128 | -0.230 ± 0.504 |
| Day 21 | 0.297 ± 0.278 | -0.182 ± 0.554 |
| Day 42 | 0.343 ± 0.250 | -0.125 ± 0.302 |
CD27 expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower CD27 expression relative to the batch mean.
| Z-Score of Fluorescence Intensity | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | -0.034 ± 0.497 | 0.070 ± 0.218 |
| Day 21 | -0.195 ± 0.372 | 0.237 ± 0.228 |
| Day 42 | -0.163 ± 0.370 | 0.149 ± 0.317 |
Tbet expression on CD8+ T cells was quantified by flow cytometry and normalized within each experimental batch using z-score normalization to account for batch-to-batch variation in fluorescence intensity. A z-score of 0 represents the mean fluorescence intensity for the marker within a given experimental batch. Positive z-scores indicate fluorescence intensity above the batch mean, whereas negative z-scores indicate fluorescence intensity below the batch mean. The magnitude of the z-score reflects the number of standard deviations from the batch mean (e.g., +1 = one standard deviation above the mean; -2 = two standard deviations below the mean). Because this is a biomarker measurement rather than a clinical outcome, higher or lower z-scores should not be characterized as inherently "better" or "worse"; they simply indicate higher or lower Tbet expression relative to the batch mean.
| Z-Score of Fluorescence Intensity | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 0.554 ± 0.297 | 0.337 ± 0.246 |
| Day 21 | 0.712 ± 0.303 | 0.373 ± 0.123 |
| Day 42 | 0.883 ± 0.464 | 0.360 ± 0.154 |
Change in prevalence of naive CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
| Percentage of CD8+ Cells | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 37.751 ± 23.184 | 49.600 ± 26.921 |
| Day 21 | 21.299 ± 5.809 | 48.687 ± 26.142 |
| Day 42 | 34.637 ± 19.291 | 47.175 ± 26.568 |
Change in prevalence of Effector Memory (EM) CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
| Percentage of CD8+ T Cells | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 22.005 ± 13.949 | 20.332 ± 14.744 |
| Day 21 | 30.436 ± 10.721 | 20.197 ± 13.862 |
| Day 42 | 23.483 ± 14.755 | 21.479 ± 13.106 |
Change in prevalence of Central Memory (CM) CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
| Percentage of CD8+ Cells | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 25.328 ± 16.857 | 16.568 ± 9.845 |
| Day 21 | 21.718 ± 17.008 | 19.244 ± 11.016 |
| Day 42 | 18.299 ± 15.837 | 20.438 ± 11.078 |
Change in prevalence of Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells (expressed as a percentage of all CD8+ T cells), as indicated by the markers CCR7 and CD45RA, at Days 0, 21, and 42 of treatment. Results are broken down in accordance with response status (responders vs. non-responders). Naive CD8+ T cells are designated by CCR7 and CD45RA positivity (naive = CCR7+CD45RA+). Effector Memory (EM) CD8+ T cells are designated by CCR7 positivity and CD45RA negativity (EM = CCR7+CD45RA-). Terminally Differentiated Effector Memory (TEMRA) CD8+ T cells are designated by CCR7 negativity and CD45RA positivity (TEMRA = CCR7-CD45RA+). Central Memory (CM) CD8+ T cells are designated by CCR7 and CD45RA negativity (CM = CCR7-CD45RA-).
| Percentage of CD8+ T Cells | Responders (Per RECIST) to FMT + Pembrolizumab | Non-Responders (Per RECIST) to FMT + Pembrolizumab |
|---|---|---|
| Day 0 | 14.916 ± 11.662 | 13.500 ± 8.541 |
| Day 21 | 26.547 ± 22.030 | 11.871 ± 6.628 |
| Day 42 | 23.580 ± 12.101 | 10.908 ± 5.011 |
Collected over All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fecal Microbiota Transplant (FMT) With Pembrolizumab | 14/20 (70%) | 12/20 (60%) | 19/20 (95%) |
| Event | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Acute kidney injuryRENAL AND URINARY DISORDERS | 1/6 |
| ArthralgiaMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 1/6 |
| Atrial fibrillationCARDIAC DISORDERS | 1/6 |
| DepressionPSYCHIATRIC DISORDERS | 1/6 |
| DyspneaRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 1/6 |
| FallINJURY, POISONING AND PROCEDURAL COMPLICATIONS | 1/6 |
| Failure to ThriveGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 1/6 |
| HypercalcemiaMETABOLISM AND NUTRITION DISORDERS | 1/6 |
| CellulitisINVESTIGATIONS | 1/6 |
| specifymyopathyINVESTIGATIONS | 1/6 |
| Event | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| AnemiaBLOOD AND LYMPHATIC SYSTEM DISORDERS | 14/20 |
| HypertensionVASCULAR DISORDERS | 12/20 |
| HyponatremiaMETABOLISM AND NUTRITION DISORDERS | 12/20 |
| ConstipationGASTROINTESTINAL DISORDERS | 7/20 |
| DiarrheaGASTROINTESTINAL DISORDERS | 7/20 |
| FatigueGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 7/20 |
| Increased LDHINVESTIGATIONS | 7/20 |
| Lymphocyte count decreasedINVESTIGATIONS | 7/20 |
| PainGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 7/20 |
| Alkaline phosphatase increasedINVESTIGATIONS | 6/20 |
All patients enrolled in the FMT recipient study
| Age, Continuous(years) | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Mean | 58.85 ± 13.91 |
| Sex: Female, Male(Participants) | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Female | 6 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Fecal Microbiota Transplant (FMT) With Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Sep 2023, 66 months.
Results were first posted in Oct 2024, 1 year 1 month after primary completion.
Of 278 non-industry phase 2 interventional studies under Melanoma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 94. This study's 66 months is close to that.
Counting every sponsor, half of 384 studies reached it within 53 months; a quarter within 32 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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