ClinicalTrials.gg
Active, not recruitingNCT03414229Updated Apr 23, 2026Results posted

A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

A Phase 2 interventional study of Epacadostat and Pembrolizumab in Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 64 studies in Sarcoma by Memorial Sloan Kettering Cancer Center — 8 open to participants now, 21 under way, 1 of them phase 3. Sarcoma · Memorial Sloan Kettering Cancer Center.

Enrollment
24th of 43
30 · median 32
Started
2018
the only one that year
Phase 2
34 of 64
2 open now
Primary completion
2024-09
later than 0 of 20 live
Registered
52nd of 64
by date

Among the 64 studies in Sarcoma by Memorial Sloan Kettering Cancer Center, this one is the 24th largest by enrollment of the 43 interventional ones that give a count, is the only one that started in 2018, is one of 34 in phase 2, reaches primary completion later than 0 of the 20 other live ones, and was the 52nd registered.

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 365 are open to participants now.

Browse Sarcoma studies →

Open to participants now

8 of the 64 studies in Sarcoma by Memorial Sloan Kettering Cancer Center are open now, in 1 country. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 301 Sarcoma studies recruiting now, 191 (63%) set no upper age limit and 83 (28%) stop at 75 or younger; 92 take children under 18; 12 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 64 studies in Sarcoma by Memorial Sloan Kettering Cancer Center, or all of them as a file.
02

Study summary

The purpose of this study is to test any good and bad effects of the combination therapy of epacadostat and pembrolizumab and to determine how well the combination therapy works in the treatment of patients with sarcoma.

03

Conditions studied

  • Sarcoma

Browse trials for

Keywords

  • Epacadostat
  • Pembrolizumab
  • 17-508
04

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

  • Male or female age ≥ 18 years at the time of
  • Be willing and able to provide written informed consent/assent for the trial
  • Be willing to comply with treatment protocol
  • Subjects must have a confirmed and/or locally advanced sarcoma
  • Adequate performance status: 0 or 1/ 100-70%
  • Subjects must have at least one (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma. An exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma). Any patient that refuses standard chemotherapy for the treatment of their disease is also considered eligible. Prior therapy will not count provided it was completed more than 6 months previously.
  • Presence of measureable disease per v1.1.Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
  • All subjects must agree to pre-treatment tumor . Subjects in whom biopsy is technically not feasible or in whom would result in unacceptable risk, in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator.
  • Adequate organ function determined within 21 days of treatment initiation
  • Hematological

    • (ANC) ≥1,000 /mcL
    • ≥75,000 / mcL
    • ≥8 g/dL or ≥5.0 mmol/L
  • Renal

    °Serum creatinine OR Measured or calculateda ( can also be used in place of creatinine or CrCl) ≤1.5 X (ULN) OR

    ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN aCreatinine clearance should be calculated per institutional standard.

  • Hepatic

    • Serum total ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
    • (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
    • Albumin ≥ 2.5 mg/dL
  • Coagulation

    • 52 or Prothrombin Time ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Women of must have a negative serum pregnancy test at screening and ≤ 72 hours prior to day 1 of study treatment.
  • Male and female subjects of childbearing potential must be willing to use an adequate method of as outlined in Section 11.7, for the course of the study through 120 days after the last dose of study medication.

Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled intercurrent illness including current active infection requiring systemic therapy or symptomatic congestive heart failure within 6 months
  • Has known active central nervous system (CNS) and/or carcinomatous meningitis. Subjects 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 for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Evidence of such as the following:

    • Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
    • Concurrent opportunistic infection
    • Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for steroid use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator. The dose of steroid allowed in this setting is also at the discretion of the principal investigator. (Use of inhaled or topical steroids is permitted.)
  • History or evidence of symptomatic disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
  • Known history of (HIV) (HIV 1/2 antibodies) disease
  • Has known active (e.g., Hepatitis B Virus PCR is detected) or (e.g., HCV RNA [qualitative] is detected).
  • Patients who have received a within 30 days of the start date of the planned study therapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. 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.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Is 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 2 weeks of the first dose of treatment.
  • Has had a prior chemotherapy, immunotherapy, biological therapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.

    • Note: Subjects with ≤ Grade 2 neuropathy, alopecia or hypothyroidism are an exception to this criterion and may qualify for the study.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy events due to a previously administered agent.
  • Presence of a gastrointestinal condition that may affect drug absorption
  • Known allergy or reaction to any component of either study drug formulation
  • Women who are pregnant or breast feeding
  • Subjects 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 study treatment(s).
  • Inability to comply with protocol required procedures
  • Subjects receiving Monoamine Oxidase Inhibitors (MAOIs) or drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within the 21 days before screening.
  • Any history of Serotonin Syndrome (SS) after receiving serotonergic drugs.
  • History or presence of an abnormal (ECG) that, in the investigator's opinion, is clinically meaningful. Screening 480 milliseconds is excluded. In the event that a single QTc is ≥ 480 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is \< 480 milliseconds. For subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the JTc interval may be used in place of the QTc with the approval of the principal investigator. The JTc must be \< 340 milliseconds if JTc is used in place of the QTc. Subjects with left bundle branch block are excluded.

Note: QTc prolongation due to pacemaker may enroll if the JTc is normal.

  • Use of any UGT1A9 inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid.
  • History of prior therapy with an IDO1 inhibitor in combination with an /anti-PD-L1 agent/any other drug specifically targeting checkpoint pathways. Patients who have received prior therapy with single agent anti-PD-1/anti-PD-L1 therapy or single agent IDO1 inhibitor will be eligible for this study.
  • Presence of any other concurrent active
Terms in these criteria, in plain language(34)

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.

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.

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.

Metastases

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

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.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    UPS, Liposarcoma or pleomorphic liposarcoma

    Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

    Drug: Epacadostat · Drug: Pembrolizumab

  • Experimental
    Leiomyosarcoma

    Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

    Drug: Epacadostat · Drug: Pembrolizumab

  • Experimental
    Vascular Sarcoma Subtypes

    Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

    Drug: Epacadostat · Drug: Pembrolizumab

  • Experimental
    Other

    Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

    Drug: Epacadostat · Drug: Pembrolizumab

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Patients With Best Objective Response Rate

    by RECIST 1.1.

    Time frame: by 24 weeks

07

Results

Posted May 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneUPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOther
Started105510
Completed1000
Not completed95510
Withdrew: Adverse event1021
Withdrew: Lack of efficacy7419
Withdrew: Change in therapy1000
Withdrew: Pregnancy0010
Withdrew: Withdrawal by subject0110

Outcome measures

PrimaryNumber of Patients With Best Objective Response Rate

by RECIST 1.1.

Time frame:
by 24 weeks
Reported as:
Count of participants · Participants
Number of Patients With Best Objective Response Rate
ParticipantsUPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOther
Participants with PR0100
Participants without PR104510

Adverse events

Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
UPS, Liposarcoma or Pleomorphic Liposarcoma7/10 (70%)1/10 (10%)10/10 (100%)
Leiomyosarcoma4/5 (80%)0/5 (0%)5/5 (100%)
Vascular Sarcoma Subtypes2/5 (40%)0/5 (0%)5/5 (100%)
Other9/10 (90%)1/10 (10%)10/10 (100%)
Most frequent serious events
Most frequent serious events
EventUPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOther
HypertensionVascular disorders0/100/50/51/10
DyspneaRespiratory, thoracic and mediastinal disorders1/100/50/50/10
FeverGeneral disorders1/100/50/50/10
Non-cardiac chest painGeneral disorders1/100/50/50/10
PneumothoraxRespiratory, thoracic and mediastinal disorders1/100/50/50/10
Most frequent other events
Showing 10 of 109
Most frequent other events
EventUPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOther
FatigueGeneral disorders4/104/54/55/10
Alanine aminotransferase increasedInvestigations1/100/53/50/10
Alkaline phosphatase increasedInvestigations1/100/53/53/10
ConstipationGastrointestinal disorders3/103/51/52/10
PainGeneral disorders5/103/50/55/10
AnemiaBlood and lymphatic system disorders3/101/52/53/10
Aspartate aminotransferase increasedInvestigations0/100/52/53/10
HypertensionVascular disorders2/102/51/52/10
HypomagnesemiaMetabolism and nutrition disorders1/100/52/52/10
MyalgiaMusculoskeletal and connective tissue disorders0/102/50/54/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)UPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOtherTotal
Median54 (35 to 78)62 (37 to 76)53 (34 to 71)45 (24 to 75)54 (24 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)UPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOtherTotal
Female332412
Male723618
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)UPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOtherTotal
Hispanic or Latino00101
Not Hispanic or Latino10541029
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)UPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOtherTotal
American Indian or Alaska Native00000
Asian00123
Native Hawaiian or Other Pacific Islander00000
Black or African American00011
White952723
More than one race00000
Unknown or Not Reported10203
Region of Enrollment
Region of Enrollment(Participants)UPS, Liposarcoma or Pleomorphic LiposarcomaLeiomyosarcomaVascular Sarcoma SubtypesOtherTotal
United States10551030
08

Study locations

1 site
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

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 Jan 2018 to primary completion in Sep 2024, 79 months.

Results were first posted in May 2025, 7 months after primary completion.

Of 198 non-industry phase 2 interventional studies under Sarcoma, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 46 and three quarters within 91. This study's 79 months is above that.

Counting every sponsor, half of 227 studies reached it within 66 months; a quarter within 43 and three quarters within 92.

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

Registered
Jan 23, 2018
First posted
Jan 29, 2018
StartActual
Jan 23, 2018
Primary completionActual
Sep 9, 2024
CompletionEst.
Jan 2027
Results first posted
May 2, 2025
Last update
Apr 23, 2026
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 Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03414229
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Jan 23, 2018
Primary completion
Sep 9, 2024
Completion
Jan 2027 (estimated)
Results posted
May 2, 2025
Last update
Apr 23, 2026

Study contacts

Sandra D'Angelo, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

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

Not currently enrolling

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Epacadostat

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