ClinicalTrials.gg
CompletedNCT03290079Updated Dec 22, 2025Results posted

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

A Phase 2 interventional study of Pembrolizumab and Lenvatinib in Neuroendocrine Tumors, Neuroendocrine Carcinoma and Neuroendocrine Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Primary conditionCarcinoma, NeuroendocrineRegistry: Neuroendocrine TumorsReclassifiedWhy we changed it
Registry
Neuroendocrine Tumors — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Neuroendocrine
Why
  1. The study's listed conditions name Carcinoma, Neuroendocrine, a narrower term within Neuroendocrine Tumors.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 73 studies in Carcinoma, Neuroendocrine with a site in United States — 19 open to participants now, 32 under way, 1 of them phase 3. Carcinoma, Neuroendocrine · United States.

Enrollment
52nd of 65
20 · median 60
Started
2017
with 4 others
Phase 2
30 of 73
2 open now
Registered
34th of 73
by date
Lead sponsor
3 of 73
H. Lee Moffitt Cancer Center and Research Institute

Among the 73 studies in Carcinoma, Neuroendocrine with a site in United States, this one is the 52nd largest by enrollment of the 65 interventional ones that give a count, is one of 5 that started in 2017, is one of 30 in phase 2, and was the 34th registered.

Carcinoma, Neuroendocrine

172 studies on the registry are indexed under Carcinoma, Neuroendocrine; 66 are open to participants now.

Browse Carcinoma, Neuroendocrine studies →

Open to participants now

19 of the 73 studies in Carcinoma, Neuroendocrine with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

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 →

Who these studies take

Of the 47 Carcinoma, Neuroendocrine studies recruiting now, 30 (64%) set no upper age limit and 10 (21%) stop at 75 or younger; 2 take children under 18; none 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.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 73 studies in Carcinoma, Neuroendocrine with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to:

  • Assess overall radiographic response rate (ORR)
  • Assess progression-free survival (PFS)
  • Test the safety and tolerability of Pembrolizumab in combination with lenvatinib
03

Conditions studied

  • Neuroendocrine Tumors
  • Neuroendocrine Carcinoma
  • Neuroendocrine Cancer

Browse trials for

Keywords

  • well-differentiated neuroendocrine tumors
04

In context

Carcinoma, Neuroendocrine Reclassified

172 studies on the registry are indexed under Carcinoma, Neuroendocrine; 66 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 144 interventional studies indexed under Carcinoma, Neuroendocrine.

Browse Carcinoma, Neuroendocrine studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Compared within Carcinoma, Neuroendocrine, 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 →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Diagnosis/Condition for entry into the trial: well differentiated neuroendocrine tumors of primary lung, thymic, small bowel and colorectal origin (including unknown primary)
  • Evidence of radiographic disease progression with scan documenting progression occurring within 8 months of signing
  • At least two . If the only prior line of treatment was adjuvant or , patient must have completed treatment within 12 months. There is no limit to number of prior therapies.
  • Willing and able to provide written informed consent/assent for the trial.
  • ≥ 18 years of age on day of signing informed consent.
  • Have based on (RECIST) 1.1.
  • Have a performance status of 0 or 1 on the (ECOG) Performance Scale.
  • Demonstrate adequate organ function and laboratory values. All screening labs should be performed within 14 days of treatment initiation.
  • Females of (FOCBP) should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
  • FOCBP must agree to use adequate as outlined in study documentation for the course of the through 120 days after the last dose of study medication.
  • Male participants of childbearing potential must agree to use an adequate method of contraception as outlined in study documentation, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion criteria

Exclusion Criteria:

  • Poorly differentiated neuroendocrine carcinoma
  • Pancreatic neuroendocrine tumor
  • Currently participating and receiving study therapy or has participated in a study of an agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • A diagnosis of immunodeficiency or is receiving systemic therapy or any other form of therapy within 7 days prior to the first dose of trial treatment.
  • Known history of active TB (Bacillus Tuberculosis)
  • to pembrolizumab or any of its .
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • 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. - Note: Potential participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If have received major surgery within 3 weeks, must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
  • Serious non-healing wound, ulcer or bone fracture
  • Has pre-existing >/= Grade 3 gastrointestinal (GI) or non-GI fistula
  • Has significant cardiovascular impairment within 12 months of the first dose of study drug
  • Known additional that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Known active central nervous system (CNS) and/or carcinomatous meningitis. Potential participants with previously treated may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
  • History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
  • An active infection requiring systemic therapy.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an , anti-PD-L1, or anti-PD-L2 agent.
  • Has received prior therapy with a tyrosine kinase inhibitor (TKI) (e.g.; sunitinib, pazopanib, cabozantinib)
  • Known history of (HIV) (HIV 1/2 antibodies).
  • Known active (e.g., HBsAg reactive) or (e.g., HCV RNA [qualitative] is detected).
  • Has received a within 30 days of planned start of study therapy. 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.
  • Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management
  • Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic, attacks, DVT within the past 6 months
  • Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration () monitoring.(Treatment with low molecular weight heparin (LMWH) is allowed)
  • Marked baseline prolongation of /QTc interval (QTc interval ≥ 480 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis
  • bleeding within 4 weeks
  • Medical need for the continued use of potent inhibitors/inducers of
  • \<30 mL/min
  • Any condition that impairs patient's ability to swallow whole pills or gastrointestinal malabsorption that, in the investigator's opinion, might affect absorption of lenvatinib
Terms in these criteria, in plain language(27)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

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.

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.

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.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

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.

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.

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.

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.

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.

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.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

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.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Pembrolizumab & Lenvatinib treatment

    Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

    Drug: Pembrolizumab · Drug: Lenvatinib

Interventions

  • 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

    Also known as: Keytruda®

  • 20 mg Lenvatinib by mouth every day of each 3 week cycle

    Also known as: Lenvima®

07

What researchers measure

Primary outcomes

  1. Objective Radiographic Response Rate (ORR)

    Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Time frame: Up to 12 months

Secondary outcomes

  1. Duration of Response (DOR)

    DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.

    Time frame: Up to 12 months

  2. Progression Free Survival (PFS)

    PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.

    Time frame: Up to 12 months

  3. Overall Survival (OS)

    OS defined as the time from initial treatment until death from any cause.

    Time frame: At 12 months

08

Results

Posted Mar 26, 2024

Participant flow

Participant flow — Overall Study
MilestonePembrolizumab & Lenvatinib Treatment
Started20
Completed18
Not completed2
Withdrew: Death2

Outcome measures

PrimaryObjective Radiographic Response Rate (ORR)

Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time frame:
Up to 12 months
Reported as:
Number · proportion of participants
Objective Radiographic Response Rate (ORR)
proportion of participantsPembrolizumab & Lenvatinib Treatment
Objective Radiographic Response Rate (ORR).1 (.03 to .30)
SecondaryDuration of Response (DOR)

DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.

Time frame:
Up to 12 months
Reported as:
Mean · months
Duration of Response (DOR)
monthsPembrolizumab & Lenvatinib Treatment
Duration of Response (DOR)6.5 (4.8 to 7.4)
SecondaryProgression Free Survival (PFS)

PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.

Time frame:
Up to 12 months
Reported as:
Median · months
Progression Free Survival (PFS)
monthsPembrolizumab & Lenvatinib Treatment
Progression Free Survival (PFS)8 (5.8 to 10.2)
SecondaryOverall Survival (OS)

OS defined as the time from initial treatment until death from any cause.

Time frame:
At 12 months
Reported as:
Number · percentage of participants
Overall Survival (OS)
percentage of participantsPembrolizumab & Lenvatinib Treatment
Overall Survival (OS)70 (48.1 to 84.4)

Adverse events

Collected over Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembrolizumab & Lenvatinib Treatment6/20 (30%)12/20 (60%)20/20 (100%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventPembrolizumab & Lenvatinib Treatment
Disease ProgressionGeneral disorders3/20
FeverGeneral disorders2/20
Death, NOSGeneral disorders2/20
Pericardial effusionCardiac disorders2/20
Sinus tachycardiaCardiac disorders2/20
Kidney InfectionInfections and infestations1/20
Lower gastrointestinal hemorrhageGastrointestinal disorders1/20
Abdominal PainGastrointestinal disorders1/20
ConstipationGastrointestinal disorders1/20
Alanine aminotransferase increasedInvestigations1/20
Most frequent other events
Showing 10 of 114
Most frequent other events
EventPembrolizumab & Lenvatinib Treatment
HypertensionVascular disorders15/20
FatigueGeneral disorders12/20
Abdominal PainGastrointestinal disorders11/20
DiarrheaGastrointestinal disorders11/20
HeadacheNervous system disorders9/20
Weight lossInvestigations8/20
ProteinuriaRenal and urinary disorders8/20
ConstipationGastrointestinal disorders7/20
Back painMusculoskeletal and connective tissue disorders7/20
ArthralgiaMusculoskeletal and connective tissue disorders6/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pembrolizumab & Lenvatinib Treatment
<=18 years0
Between 18 and 65 years9
>=65 years11
Sex: Female, Male
Sex: Female, Male(Participants)Pembrolizumab & Lenvatinib Treatment
Female8
Male12
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pembrolizumab & Lenvatinib Treatment
Hispanic or Latino4
Not Hispanic or Latino15
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pembrolizumab & Lenvatinib Treatment
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White18
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Pembrolizumab & Lenvatinib Treatment
United States20
09

Study locations

1 site
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612, United States
10

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

11

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jan 2023, 60 months.

Results were first posted in Mar 2024, 1 year 2 months after primary completion.

Of 43 phase 2 interventional studies under Carcinoma, Neuroendocrine, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 91. This study's 60 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Sep 21, 2017
StartActual
Dec 15, 2017
Primary completionActual
Jan 10, 2023
CompletionActual
May 13, 2024
Results first posted
Mar 26, 2024
Last update
Dec 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT03290079
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Dec 15, 2017
Primary completion
Jan 10, 2023
Completion
May 13, 2024
Results posted
Mar 26, 2024
Last update
Dec 22, 2025

Study contacts

Jonathan Strosberg, M.D.
principal investigator · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drugs tested here: Pembrolizumab · Lenvatinib

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