A Phase 2 interventional study of Arterial Embolization and Pembrolizumab in Metastatic Malignant Neoplasm in the Liver and Neuroendocrine Neoplasm, sponsored by Nicholas Fidelman, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Nicholas Fidelman, MD · Phase 2, Interventional, and Treatment
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Among 23 studies testing lutetium Lu 177 dotatate in Neuroendocrine Tumors — 3 open to participants now, 6 under way, none of them phase 3. lutetium Lu 177 dotatate · Neuroendocrine Tumors.
Among the 23 studies testing lutetium Lu 177 dotatate in Neuroendocrine Tumors, this one is the 10th largest by enrollment, is one of 2 that started in 2018, is one of 10 in phase 2, and was the 8th registered.
542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.
Browse Neuroendocrine Tumors studies →3 of the 23 studies testing lutetium Lu 177 dotatate in Neuroendocrine Tumors are open now, in 3 countries. Recruiting first, the newest first:
Fundación de investigación HM · Sites in Spain
Ages 3+
University of Iowa · Sites in United States
Ages 18+
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Ages 18+
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 112 Neuroendocrine Tumors studies recruiting now, 73 (65%) set no upper age limit and 17 (15%) stop at 75 or younger; 12 take children under 18; 4 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.
23 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 8 · Phase 2 13 · Phase 3 4
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 41 across 387 interventional studies indexed under Neuroendocrine Tumors.
Median enrollment 31 across the 23 interventional studies. Of the 11 that completed or were terminated, 2 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 23 have an industry lead sponsor. The 10 most frequent:
Nicholas Fidelman, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Nicholas Fidelman, MD has 2 studies filed under Neuroendocrine Tumors — fewer than ten, so there is no comparison to draw.
2 of the studies testing lutetium Lu 177 dotatate in Neuroendocrine Tumors that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04750954National Cancer Institute (NCI)Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors | 2026-12-30 |
| NCT04544098Memorial Sloan Kettering Cancer CenterLutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver | 2027-09 |
Add all 2 to your calendar (.ics) → With an account.
Among the 23 studies testing lutetium Lu 177 dotatate in Neuroendocrine Tumors, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This pilot phase II trial studies how effective pembrolizumab and liver-directed therapy or peptide receptor radionuclide therapy are at treating patients with well-differentiated neuroendocrine tumors and symptomatic and/or progressive tumors that have spread to the liver (liver metastases). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Liver-directed therapies such as radiofrequency ablation, transarterial embolization, yttrium-90 microsphere radioembolization, and cryoablation may help activate the immune system in order to shrink tumors that are not being directly targeted. Peptide receptor radionuclide therapy is a form of targeted treatment that is performed by the use of a small molecule, which carries a radioactive component attached to a peptide. Once injected into the body, this small molecule binds to some specific sites on tumor cells called receptors and emit medium energy radiation that can destroy cells. Because this radionuclide is attached to the peptide, which binds receptors on tumor lesions, the radiation can preferably be targeted to the tumor cells in order to destroy them. Giving pembrolizumab in combination with liver-directed therapy or peptide receptor radionuclide therapy may work better than pembrolizumab alone.
PRIMARY OBJECTIVES:
I. To evaluate safety profile of pembrolizumab in combination with Peptide Receptor Radionuclide Therapy (PRRT), transarterial embolization, and radioembolization.
II. To evaluate the best observed overall response rate (ORR) in lesion(s) not targeted for liver-directed therapy (abscopal effect) to pembrolizumab plus liver-directed therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for patients with metastatic well-differentiated (WD) neuroendocrine tumors (NET)s (WD-NETs).
III. To evaluate the best observed ORR to pembrolizumab plus peptide receptor radionuclide therapy (PRRT) according to RECIST 1.1 for patients with metastatic grade 2 and 3 WD-NET (Ki-67 > 10%).
SECONDARY OBJECTIVES:
I. To evaluate duration of response (DOR) in patients receiving pembrolizumab in combination with liver-directed therapies or PRRT.
II. To evaluate progression free survival (PFS) in subjects treated with pembrolizumab in combination with liver-directed therapies or PRRT.
III. Best observed radiographic ORR per modified RECIST (mRECIST) in lesions targeted for liver-directed therapy.
IV. Duration of response in lesions targeted for liver-directed therapy by mRECIST.
EXPLORATORY OBJECTIVES:
I. To compare ORR, DOR, and PFS based on immune-related (ir)RECIST with the same measures assessed by RECIST 1.1.
II. To correlate clinical outcomes (ORR, DOR, PFS) with baseline immune cell infiltration and programmed death-ligand 1 (PD-L1) staining in cycle 1 and cycle 5 tumor biopsies.
III. To assess the level of PD-L1 expression in tumor tissue prior to liver-directed therapy (prior to PRRT) and 5 weeks following liver-directed therapy (following PRRT).
IV. To assess T cell infiltration on the pre-177Lu-DOTATATE (pre-PRRT) and on the on-treatment tumor tissue biopsies.
V. To assess baseline circulating T cell receptor (TCR) repertories and changes in TCR repertories with treatment, and correlate baseline and turnover of repertories to clinical outcomes.
VI. To analyze the relationship between baseline tumor proliferative index (as measured by Ki67) and response to therapy.
OUTLINE: Patients originally assigned to 1 of 3 groups. As of 09/15/2022, Groups 2 and 3 are closed to enrollment.
GROUP I (PRRT): Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. PRRT using 177Lu-DOTATATE(Lutathera®) will be offered to patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index > 20% (well-differentiated grade 3). Patients may have any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. 200±20 millicurie (mCi) of 177Lu-DOTATATE will be administered intravenously per treatment on outpatient basis. Patients will receive a total of four treatments of 177Lu-DOTATATE, administered every 8±1 weeks. Patients with partial response (PR) or stable disease (SD) by RECIST v. 1.1 after cycle 4 of pembrolizumab who were treated with PRRT (group 1) would continue to receive systemic IV administrations of 177Lu-DOTATATE every 8 +/-1 weeks for up to four (4) treatments. After completion of four (4) PRRT treatments, pembrolizumab may be administered alone for up to 35 cycles
CLOSED - GROUP II (TRANSARTERIAL EMBOLIZATION (TAE)): Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo TAE over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
CLOSED - GROUP III (RADIOEMBOLIZATION (RE)): Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere RE 3-15 days following the first dose of pembrolizumab.
After completion of study treatment, patients are followed up at 30 days and then every 3-6 months thereafter.
Subject Inclusion Criteria
Have a proven well-differentiated neuroendocrine tumor (WHO grade 1, grade 2, or morphologically and/or clinically well-differentiated grade 3) of any primary site, including unknown primary site.
a. For group 1, only well-differentiated grade 2 or 3 tumors with Ki-67 index > 10% that demonstrate somatostatin receptor expression on DOTA or In-111 Octreoscans will be allowed.
Radiographic, biochemical, or clinical evidence of tumor progression over a period of up to 12 months in at least one site.
Demonstrate adequate organ function.
Subject Exclusion Criteria
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \<=Grade 1 or at baseline) from adverse events due to a previously administered agent.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The 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.
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.
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.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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 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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
Biological: Pembrolizumab · Biological: Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
Procedure: Arterial Embolization · Biological: Pembrolizumab
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
Biological: Pembrolizumab · Device: Yttrium-90 Microsphere Radioembolization
Undergo TAE
Also known as: TAE, Transarterial Embolization
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
Also known as: Lutathera, 177Lu-DOTATATE
Undergo yttrium-90 microsphere RE
Also known as: Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization, Yttrium-90 Microsphere RE
Proportion of Participants With an Overall Response
The All Subjects as Treated (ASaT, ITT) population will be used for the analysis of ORR. The primary efficacy endpoint will be best observed Overall Response Rate (ORR) by RECIST 1.1 (investigator reported). ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). The proportion of participants with a response and 90% confidence interval of overall response rate will be obtained for each of the three groups separately.
Time frame: Up to 25 months
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Adverse events occurring from the start of the treatment regimen until 30 days after the end of treatment will be summarized by number of participants reporting under maximum toxicity grade for participants enrolled in Group 1. All treatment-related adverse events will be graded using NCI CTCAE v5.0.
Time frame: Up to 30 days after the end of treatment, approximately 26 months
Median Duration of Response (DOR)
Kaplan-Meier method will be used to summarize DOR for participants with a documented complete response or partial response per RECIST v.1.1 criteria. . Median DOR and its 95% confidence interval will be obtained for each of the three liver-directed therapies and PRRT groups separately.
Time frame: Up to 3 years
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Adverse events occurring from the start of the treatment regimen until 30 days after the end of treatment will be summarized by number of participants reporting under the maximum toxicity grade for participants enrolled in Groups 2 and 3. All treatment-related adverse events will be graded using NCI CTCAE v5.0.
Time frame: Up to 30 days after the end of treatment, approximately 26 months
Median Progression Free Survival (PFS)
Progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by RECIST v1.1. Kaplan-Meier methods will be used to estimate PFS with 95% confidence interval for each group separately.
Time frame: Up to 3 years
Immune-related Progression Free Survival (irPFS)
Immune-related progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by immune-related-RECIST (irRC). Kaplan-Meier methods will be used to estimate irPFS with 95% confidence interval for each group separately.
Time frame: Up to 3 years
| Milestone | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| Started | 26 | 3 | 3 |
| Completed | 26 | 3 | 3 |
| Not completed | 0 | 0 | 0 |
The All Subjects as Treated (ASaT, ITT) population will be used for the analysis of ORR. The primary efficacy endpoint will be best observed Overall Response Rate (ORR) by RECIST 1.1 (investigator reported). ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). The proportion of participants with a response and 90% confidence interval of overall response rate will be obtained for each of the three groups separately.
| proportion of participants | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| Proportion of Participants With an Overall Response | 0.35 (0.20 to 0.52) | 0 (0 to 0.63) | 0 (0 to 0.63) |
Adverse events occurring from the start of the treatment regimen until 30 days after the end of treatment will be summarized by number of participants reporting under maximum toxicity grade for participants enrolled in Group 1. All treatment-related adverse events will be graded using NCI CTCAE v5.0.
| Participants | Group I [Pembrolizumab, 177Lu DOTATATE] |
|---|---|
| Grade 4 Hyponatremia | 3 |
| Grade 3 Anemia | 1 |
| Grade 3 Colitis | 1 |
| Grade 3 Hyperglycemia | 2 |
| Grade 3 Hypokalemia | 1 |
| Grade 3 Lymphocyte count decreased | 2 |
| Grade 3 Neutrophil count decreased | 2 |
| Grade 3 Platelet count decreased | 1 |
| Grade 3 Small intestinal obstruction | 1 |
| Grade 3 White blood cell decreased | 1 |
| Grade 2 Abdominal Pain | 2 |
| Grade 2 Acidosis | 1 |
| Grae 2 Adrenal insufficiency | 1 |
| Grade 2 Alanine aminotransferase increased | 1 |
| Grade 2 Anorexia | 1 |
| Grade 2 Anxiety | 1 |
| Grade 2 Arthralgia | 1 |
| Grade 2 Blurred vision | 1 |
| Grade 2 Creatinine increased | 1 |
| Grade 2 Dysgeusia | 1 |
| Grade 2 Fatigue | 1 |
| Grade 2 Nausea | 3 |
| Grade 2 Hypothyroidsim | 4 |
| Grade 2 Rash maculo-papular | 1 |
| Grade 2 Vomiting | 3 |
| Grade 1 Alopecia | 3 |
| Grade 1 Aspartate aminotransferase increased | 3 |
| Grade 1 Back Pain | 1 |
| Grade 1 Blood bilirubin increased | 1 |
| Grade 1 Bone Pain | 1 |
| Grade 1 Bruising | 1 |
| Grade 1 Diarrhea | 4 |
| Grade 1 Dry Skin | 1 |
| Grade 1 Edema limbs | 1 |
| Grade 1 Fever | 2 |
| Grade 1 Flu like symptoms | 1 |
| Grade 1 Memory impairment | 1 |
| Grade 1 Muscle weakness lower limb | 1 |
| Grade 1 Muscle weakness trunk | 1 |
| Grade 1 Myalgia | 1 |
| Grade 1 Pruritus | 8 |
| Grade 1 Peripheral sensory neuropathy | 1 |
| Grade 1 Skin hypopigmentation | 1 |
Kaplan-Meier method will be used to summarize DOR for participants with a documented complete response or partial response per RECIST v.1.1 criteria. . Median DOR and its 95% confidence interval will be obtained for each of the three liver-directed therapies and PRRT groups separately.
| months | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| Median Duration of Response (DOR) | 9.6 (2.7 to 18.9) | — | — |
Adverse events occurring from the start of the treatment regimen until 30 days after the end of treatment will be summarized by number of participants reporting under the maximum toxicity grade for participants enrolled in Groups 2 and 3. All treatment-related adverse events will be graded using NCI CTCAE v5.0.
| Participants | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|
| Grade 2-Abdominal Pain | 0 | 1 |
| Grade 2-Alanine aminotransferase increased | 1 | 0 |
| Grade 2-Alkaline phosphatase increased | 0 | 1 |
| Grade 1-Anemia | 1 | 0 |
| Grade 2-Anorexia | 0 | 2 |
| Grade 3-Aspartate aminotransferase increased | 1 | 0 |
| Grade 2-Bloating | 0 | 1 |
| Grade 2-Blood bilirubin increased | 0 | 1 |
| Grade 1 Brusing | 1 | 0 |
| Grade 2-Dyspnea | 0 | 1 |
| Grade 3-Fatigue | 0 | 2 |
| Grade 1-Fever | 1 | 1 |
| Grade 1-Hyperthyroidism | 0 | 1 |
| Grade 1-Hyponatremia | 1 | 0 |
| Grade 2 Hypothyroidism | 1 | 1 |
| Grade 1-INR Increased | 0 | 1 |
| Grade 1-Myalgia | 1 | 0 |
| Grade 1-Nausea | 1 | 2 |
| Grade 2-Pain | 1 | 0 |
| Grade 1-Platelet count decreased | 2 | 0 |
| Grade 3-Pneumonitis | 1 | 0 |
| Grade 1-Vomiting | 0 | 1 |
Progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by RECIST v1.1. Kaplan-Meier methods will be used to estimate PFS with 95% confidence interval for each group separately.
| months | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| Median Progression Free Survival (PFS) | 13.3 (8.4 to 18.4) | 8 (NA to NA) | 2 (NA to NA) |
Immune-related progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by immune-related-RECIST (irRC). Kaplan-Meier methods will be used to estimate irPFS with 95% confidence interval for each group separately.
| months | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| Immune-related Progression Free Survival (irPFS) | 13.3 (8.4 to 18.4) | 8 (NA to NA) | 2 (NA to NA) |
Collected over Up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I [Pembrolizumab, 177Lu DOTATATE] | 4/26 (15.4%) | 14/26 (53.8%) | 26/26 (100%) |
| Group II [Pembrolizumab, TAE] | 0/3 (0%) | 3/3 (100%) | 3/3 (100%) |
| Group III [Pembrolizumab, Yttrium-90 Microsphere RE] | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Event | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| FatigueGeneral disorders | 0/26 | 0/3 | 2/3 |
| Abdominal painGastrointestinal disorders | 1/26 | 1/3 | 0/3 |
| Alkaline phosphatase increasedInvestigations | 0/26 | 1/3 | 0/3 |
| Aspartate aminotransferase increasedInvestigations | 0/26 | 1/3 | 0/3 |
| Bile duct stenosisHepatobiliary disorders | 0/26 | 1/3 | 0/3 |
| Blood Bilirubin increasedInvestigations | 0/26 | 1/3 | 0/3 |
| ConstipationGastrointestinal disorders | 0/26 | 1/3 | 0/3 |
| HypertensionVascular disorders | 0/26 | 1/3 | 0/3 |
| Lung infectionInfections and infestations | 1/26 | 0/3 | 1/3 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/26 | 1/3 | 0/3 |
| Event | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] |
|---|---|---|---|
| FatigueGeneral disorders | 17/26 | 3/3 | 2/3 |
| Lung infectionInfections and infestations | 0/26 | 0/3 | 3/3 |
| NauseaGastrointestinal disorders | 12/26 | 3/3 | 2/3 |
| Abdominal distensionGastrointestinal disorders | 0/26 | 0/3 | 2/3 |
| Abdominal painGastrointestinal disorders | 11/26 | 2/3 | 1/3 |
| Alanine aminotransferase increasedInvestigations | 6/26 | 2/3 | 1/3 |
| Alkaline phosphatase increasedInvestigations | 1/26 | 2/3 | 1/3 |
| AnemiaBlood and lymphatic system disorders | 5/26 | 2/3 | 0/3 |
| AnorexiaMetabolism and nutrition disorders | 3/26 | 0/3 | 2/3 |
| Aspartate aminotransferase increasedInvestigations | 6/26 | 2/3 | 2/3 |
| Age, Customized(Participants) | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] | Total |
|---|---|---|---|---|
| 20 - 29 years old | 1 | 0 | 0 | 1 |
| 30 - 39 years old | 1 | 1 | 0 | 2 |
| 40 - 49 years old | 4 | 0 | 1 | 5 |
| 50 - 59 years old | 7 | 0 | 1 | 8 |
| 60 - 69 years old | 6 | 0 | 1 | 7 |
| 70 -79 years old | 7 | 2 | 0 | 9 |
| Sex: Female, Male(Participants) | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] | Total |
|---|---|---|---|---|
| Female | 11 | 2 | 2 | 15 |
| Male | 15 | 1 | 1 | 17 |
| Race (NIH/OMB)(Participants) | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 1 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 18 | 2 | 1 | 21 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 3 | 0 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 2 |
| Not Hispanic or Latino | 24 | 2 | 3 | 29 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Group I [Pembrolizumab, 177Lu DOTATATE] | Group II [Pembrolizumab, TAE] | Group III [Pembrolizumab, Yttrium-90 Microsphere RE] | Total |
|---|---|---|---|---|
| United States | 26 | 3 | 3 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Jul 2025, 83 months.
Results were first posted in Aug 2026, 1 year after primary completion.
Of 85 non-industry phase 2 interventional studies under Neuroendocrine Tumors, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 83. This study's 83 months is above that.
Counting every sponsor, half of 98 studies reached it within 65 months; a quarter within 42 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pembrolizumab · Lutetium Lu 177 dotatate
Nicholas Fidelman, MD