A Phase 2 interventional study of Nivolumab and Ipilimumab in Neuroendocrine Tumors and Carcinoid Tumor, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment
Among 65 studies in Carcinoid Tumor with a site in United States — 7 open to participants now, 10 under way, 3 of them phase 3. Carcinoid Tumor · United States.
Among the 65 studies in Carcinoid Tumor with a site in United States, this one is the 52nd largest by enrollment of the 57 interventional ones that give a count, is one of 2 that started in 2018, is one of 30 in phase 2, and was the 52nd registered.
104 studies on the registry are indexed under Carcinoid Tumor; 11 are open to participants now.
Browse Carcinoid Tumor studies →7 of the 65 studies in Carcinoid Tumor with a site in United States are open now. Recruiting first, the newest first:
Washington University School of Medicine · Sites in United States
Ages 18+
RayzeBio, Inc. · Sites in United States, Canada
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–100
Fox Chase Cancer Center · Sites in United States
Ages 18+
Cedars-Sinai Medical Center · Sites in United States
Ages 18–99
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 10 Carcinoid Tumor studies recruiting now, 7 (70%) set no upper age limit and none (0%) stop at 75 or younger; 1 takes children under 18; none take healthy volunteers.
This study: 18 Years to 100 Years · 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.
65 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 18 · Phase 2 37 · Phase 3 7 · Phase 4 1
First in 2002; 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 9 is below the median of 44 across 73 interventional studies indexed under Carcinoid Tumor.
Median enrollment 44 across the 57 interventional studies, 167 across the 7 observational. Of the 46 that completed or were terminated, 30 (65%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 65 have an industry lead sponsor. The 10 most frequent:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 71 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 68 (60%) have results posted.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins has 1 study filed under Carcinoid Tumor — fewer than ten, so there is no comparison to draw.
7 of the studies in Carcinoid Tumor with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05477576Phase 3RayzeBio, Inc.Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy | 2026-12 |
| NCT07087054Phase 3Crinetics Pharmaceuticals Inc.Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen | 2027-08 |
| NCT05263050Fox Chase Cancer CenterTrial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors | 2026-12 |
| NCT04993261M.D. Anderson Cancer CenterAn Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors | 2026-12-31 |
| NCT07165132RayzeBio, Inc.Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. | 2027-02 |
Add all 7 to your calendar (.ics) → With an account.
Among the 65 studies in Carcinoid Tumor with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single arm open-label design study looking at Nivolumab plus Ipilimumab in patients with Advanced Neuroendocrine Tumors. Patients will be dosed Nivolumab 240mg IV over 60 minutes every 2 weeks (Q2W) and Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W). One cycle will include 3 doses of Nivolumab and 1 dose of Ipilimumab. The objective of this study is to evaluate the objective response rate of combination Nivolumab and Ipilimumab in advanced, well-differentiated neuroendocrine tumors. Durability of response, and progression free survival (PFS) will also be described.
Subjects with progressive, non-functional advanced or metastatic thoracic, GI or pancreatic well-differentiated neuroendocrine tumors (NET) have few treatment options. The only FDA approved treatment regimen offers little response potential. In currently unpublished data with inhibitory immune checkpoint agents, patients with NET have shown promising clinical benefit. This therapy offers a novel approach to potentially provide long term benefit, but must be further explored. The safety profile of nivolumab plus ipilimumab is characterized by immune-related toxicities, such as diarrhea, rash, pneumonitis, liver toxicity, and endocrinopathies (Nivolumab, Ipilimumab Investigator's Brochures). The frequencies and intensities of these events in the combination are variable and depend on the specific doses and schedule used. In the dosing schedules selected, these events were mostly low grade and manageable with the use of corticosteroids. Nivolumab and ipilimumab combination therapy has shown improved efficacy over either agent alone in melanoma. Rationale for Single Arm Design This study will use a single arm open-label design. The objective of this study is to evaluate the objective response rate of combination nivolumab and ipilimumab in advanced, well-differentiated neuroendocrine tumors. Durability of response, and PFS will also be described.
104 studies on the registry are indexed under Carcinoid Tumor; 11 are open to participants now.
This study's enrollment of 9 is below the median of 44 across 73 interventional studies indexed under Carcinoid Tumor.
Browse Carcinoid Tumor studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 71 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 68 (60%) have results posted.
Compared within Carcinoid Tumor, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuroendocrine Tumors. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Subjects with confirmed advanced, progressive, well-differentiated nonfunctional NET of the pancreas, lung or gastrointestinal (GI) tract per the 8th International Association for the Study of Lung Cancer classification (IASLC) or the American Joint Committee on Cancer (AJCC) Staging Handbook, 7th edition. Progression must be documented over the prior 12 months.
(AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (≤ 5 x ULN in the presence of liver )
CrCl = (140 - age in years) x weight in kg x 0.85
o 72 x serum creatinine in mg/dL
CrCl = (140 - age in years) x weight in kg x 1.00
Subjects with poorly differentiated or small cell carcinoma histology
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.
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 line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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).
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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 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.
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.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Nivolumab 240 mg IV over 60 minutes every 2 weeks (Q2W) Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W)
Drug: Nivolumab · Drug: Ipilimumab
240mg IV over 60 minutes Q2W
Also known as: Bristol Myers Squibb (BMS), BMS-936558
1mg/kg IV over 30 minutes Q6W
Also known as: Bristol Myers Squibb (BMS), BMS-734016
Objective Response Rate (ORR) of Neuroendocrine Tumor (NET) of the Lung, Pancreas, and Gastrointestinal (GI) Tract
The number of subjects who have at least one scan with an Objective Response (OR) of confirmed complete response (CR) or partial response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Objective Response (OR), a response of CR or PR from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters
Time frame: up to 24 months
Number of Patients Experiencing Drug-related Adverse Events
Safety as assessed by number of patients experiencing drug-related adverse events (safety and tolerability).
Time frame: up to 27 months
Number of Patients Experiencing Dose-limiting Toxicities
Safety as assessed by number of patients experiencing dose-limiting toxicities (safety and tolerability).
Time frame: up to 24 months
Progression Free Survival (PFS) at 6 Months
Percentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 6 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
Time frame: 6 months
Progression Free Survival (PFS) at 12 Months
Percentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 12 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
Time frame: 12 months
Progression Free Survival (PFS) at 24 Months
Percentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 24 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
Time frame: 24 months
Median Progression Free Survival (PFS)
Time (months) from date of randomization to progressive disease (PD) or death, whichever comes first, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
Time frame: approximately 3 years 8 months
Efficacy as Assessed by Disease Control Rate (DCR)
The number of subjects who have at least one scan with best overall response (BOR) of confirmed complete response (CR), partial response (PR), or stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Best Overall Response (BOR), best response (CR, PR, or SD) from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters; Stable Disease (SD), \<20% increase, \<30% decrease in the sum of the longest diameter of target lesions, no measurable increase in non-target lesions, and no new lesions.
Time frame: approximately 3 years 8 months
Efficacy as Assessed by Duration of Response (DOR)
Time (months) from best overall response (BOR) of complete response (CR) or partial response (PR) to progressive disease (PD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions by CT scan: Best Overall Response (BOR), best response (CR, PR, or SD) from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters; Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
Time frame: approximately 3 years 8 months
Efficacy as Assessed by Overall Survival (OS)
Number of months participants stay alive after treatment with the combination of nivolumab and ipilimumab in subjects with advanced well-differentiated nonfunctional NET of the lung, pancreas or GI tract
Time frame: approximately 3 years 8 months
| Milestone | Nivolumab Plus Ipilimumab |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
The number of subjects who have at least one scan with an Objective Response (OR) of confirmed complete response (CR) or partial response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Objective Response (OR), a response of CR or PR from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters
| Participants | Nivolumab Plus Ipilimumab |
|---|---|
| Objective Response Rate (ORR) of Neuroendocrine Tumor (NET) of the Lung, Pancreas, and Gastrointestinal (GI) Tract | 4 |
Safety as assessed by number of patients experiencing drug-related adverse events (safety and tolerability).
| Participants | Nivolumab Plus Ipilimumab |
|---|---|
| Number of Patients Experiencing Drug-related Adverse Events | 8 |
Safety as assessed by number of patients experiencing dose-limiting toxicities (safety and tolerability).
| Participants | Nivolumab Plus Ipilimumab |
|---|---|
| Number of Patients Experiencing Dose-limiting Toxicities | 2 |
Percentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 6 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
| percentage of participants | Nivolumab Plus Ipilimumab |
|---|---|
| Progression Free Survival (PFS) at 6 Months | 44 |
Percentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 12 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
| percentage of participants | Nivolumab Plus Ipilimumab |
|---|---|
| Progression Free Survival (PFS) at 12 Months | 44 |
Percentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 24 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
| percentage of participants | Nivolumab Plus Ipilimumab |
|---|---|
| Progression Free Survival (PFS) at 24 Months | 33 |
Time (months) from date of randomization to progressive disease (PD) or death, whichever comes first, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
| months | Nivolumab Plus Ipilimumab |
|---|---|
| Median Progression Free Survival (PFS) | 5.29 (2.7 to NA) |
The number of subjects who have at least one scan with best overall response (BOR) of confirmed complete response (CR), partial response (PR), or stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Best Overall Response (BOR), best response (CR, PR, or SD) from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters; Stable Disease (SD), \<20% increase, \<30% decrease in the sum of the longest diameter of target lesions, no measurable increase in non-target lesions, and no new lesions.
| Participants | Nivolumab Plus Ipilimumab |
|---|---|
| Efficacy as Assessed by Disease Control Rate (DCR) | 4 |
Time (months) from best overall response (BOR) of complete response (CR) or partial response (PR) to progressive disease (PD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions by CT scan: Best Overall Response (BOR), best response (CR, PR, or SD) from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters; Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including baseline sum, if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions.
| months | Nivolumab Plus Ipilimumab |
|---|---|
| Efficacy as Assessed by Duration of Response (DOR) | NA (8.51 to NA) |
Number of months participants stay alive after treatment with the combination of nivolumab and ipilimumab in subjects with advanced well-differentiated nonfunctional NET of the lung, pancreas or GI tract
| months | Nivolumab Plus Ipilimumab |
|---|---|
| Efficacy as Assessed by Overall Survival (OS) | NA (19.12 to NA) |
Collected over approximately 3 years 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nivolumab Plus Ipilimumab | 4/9 (44.4%) | 4/9 (44.4%) | 9/9 (100%) |
| Event | Nivolumab Plus Ipilimumab |
|---|---|
| ColitisGastrointestinal disorders | 1/9 |
| DiarrheaGastrointestinal disorders | 1/9 |
| PancreatitisGastrointestinal disorders | 1/9 |
| SepsisInfections and infestations | 1/9 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/9 |
| Productive CoughRespiratory, thoracic and mediastinal disorders | 1/9 |
| Event | Nivolumab Plus Ipilimumab |
|---|---|
| Abdominal painGastrointestinal disorders | 8/9 |
| NauseaGastrointestinal disorders | 8/9 |
| FatigueGeneral disorders | 7/9 |
| DiarrheaGastrointestinal disorders | 6/9 |
| PruritusSkin and subcutaneous tissue disorders | 6/9 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 6/9 |
| AnemiaBlood and lymphatic system disorders | 5/9 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 5/9 |
| Lymphocyte count decreasedInvestigations | 4/9 |
| Back painMusculoskeletal and connective tissue disorders | 4/9 |
| Age, Continuous(years) | Nivolumab Plus Ipilimumab |
|---|---|
| Mean | 63.7 ± 15.2 |
| Sex: Female, Male(Participants) | Nivolumab Plus Ipilimumab |
|---|---|
| Female | 3 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Nivolumab Plus Ipilimumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nivolumab Plus Ipilimumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Nivolumab Plus Ipilimumab |
|---|---|
| United States | 9 |
| Tumor Site(Participants) | Nivolumab Plus Ipilimumab |
|---|---|
| Lung | 6 |
| Pancreatic Neuroendocrine | 2 |
| Small Bowel | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Nov 2021, 44 months.
Results were first posted in Jan 2024, 2 years 1 month after primary completion. A results delay was requested in Nov 2022.
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Studies of the drugs tested here: Nivolumab · Ipilimumab
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →