ClinicalTrials.gg
RecruitingNCT03420014FIBROSARC USUpdated Oct 10, 2023

Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)

A Phase 2 interventional study of Doxorubicin and L19TNF plus doxorubicin in Leiomyosarcoma, sponsored by Philogen S.p.A.. Recruiting at 8 sites in United States. Open to participants aged 16 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Philogen S.p.A. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Dec 2018; still recruiting 7 years 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
16 Years to 100 Years
Sex
All
01

Study summary

The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.

Read the detailed description

In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).

The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for metastatic leiomyosarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1).

Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter.

02

Conditions studied

  • Leiomyosarcoma

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03

In context

Leiomyosarcoma

177 studies on the registry are indexed under Leiomyosarcoma; 35 are open to participants now.

This study's planned enrollment of 114 is above the median of 54 across 151 interventional studies indexed under Leiomyosarcoma.

Browse Leiomyosarcoma studies →

Lead sponsor

Philogen S.p.A. is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 100 Years
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

Patients may be included in the study if they meet all of the following criteria:

  1. Age ≥ 16 years. Patients under 18 years, should be fully grown (proof of fused growth plates).
  2. Patients with histological evidence of stage IV high-grade leiomyosarcoma (grade 2 - 3 according to the Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system) not amenable to curative treatment with surgery or radiotherapy.
  3. Patients must have at least one unidimensionally by computed tomography as defined by (RECIST) v.1.1. If only 1 lesion is present at screening this lesion should not have been irradiated during previous treatments.
  4. of at least 3 months in the judgment of the investigator.
  5. ≤ 1.
  6. Documented negative test for , and . For HBV serology, the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
  7. Female patients: negative serum pregnancy test for women of (WOCBP)* within 14 days of starting treatment. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
  8. Male patients: Male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g., condom with spermicidal gel). Double-barrier contraception is required.
  9. signed and dated to participate in the study.
  10. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

    • Women of childbearing potential are defined as females who have experienced menarche, are not (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).

Exclusion criteria

Exclusion Criteria:

Patients will be excluded from participating in this study if they meet one or more of the following criteria:

  1. Prior therapy (except surgery and radiation) for unresectable or malignant soft tissue sarcoma (STS).
  2. Patients with primary tumor localized to the extremities and a single resectable synchronous distant metastatic lesion.
  3. Patients eligible for preoperative treatment.
  4. Previous treatment with anthracycline-containing chemotherapy.
  5. Radiotherapy within 4 weeks prior to start of therapy.
  6. Known history of allergy to TNFα, anthracyclines or other intravenously (IV) administered human proteins/peptides/antibodies.
  7. (ANC) \< 1.5 x 109/L, \< 100 x 109/L and (Hb) \< 9.0 g/dl.
  8. Chronically impaired renal function as expressed by \< 60 mL/min or serum creatinine > 1.5 .
  9. Inadequate liver function (, AST, GGT, ALP or total ≥ 1.5 x ULN) or total bilirubin ≥ 1.5 x ULN).
  10. (INR) > 1.5 ULN.
  11. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
  12. History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
  13. Heart insufficiency (any grade, (NYHA) criteria).
  14. (LVEF) \< 50%.
  15. cardiac arrhythmias or requiring permanent medication.
  16. Abnormalities observed during baseline and Echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of /QTc prolongation would be excluded. In particular:

    • patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc >480 milliseconds using Fredricia's QT correction formula) are excluded;
    • patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded;
    • patients who require the use of concomitant medications that prolong the QT/QTc interval are excluded.
  17. Uncontrolled hypertension, despite optimal therapy.
  18. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
  19. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
  20. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
  21. Pregnancy or breast-feeding.
  22. Requirement of chronic administration of or other drugs. Limited use of corticosteroids to treat or prevent acute reactions is not considered an exclusion criterion.
  23. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
  24. Known active or latent tuberculosis (TB).
  25. Concurrent other than soft tissue sarcoma (STS), unless the patient has been disease-free for at least 2 years.
  26. Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
  27. Serious, non-healing wound, ulcer or bone fracture.
  28. Allergy to study medication or in study medication.
  29. Concurrent therapy with anticoagulants.
  30. Concurrent use of other anti-cancer treatments or agents other than study medication.
  31. Any recent within 4 weeks prior to treatment or plan to receive vaccination during the study.
Terms in these criteria, in plain language(32)

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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.

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.

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.

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.

Excipients

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (estimated)

Study arms

  • Active comparator
    Arm 1: Doxorubicin

    Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion.

    Drug: Doxorubicin

  • Experimental
    Arm 2: L19TNF plus doxorubicin

    Patients will receive a fixed dose of L19TNF in combination with a fixed dose doxorubicin. Doxorubicin will be administered as a 15 ± 5 minutes i.v. infusion on day 1 of each 21-day cycle followed by at least 30 minutes pause before starting infusion of L19TNF.

    Combination Product: L19TNF plus doxorubicin

Interventions

  • 75 mg/m2 doxorubicin will be administered once every 3 weeks (Day 1 of every 21-days cycle).

  • Combination productL19TNF plus doxorubicin

    Drug pages: Onfekafusp alfa · Doxorubicin

    13 μg/kg L19TNF will be administered on day 1, 3 and 5 of every 21-days cycle in combination with 60 mg/m2 doxorubicin on day 1 of every 21-days cycle.

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Progression-free survival PFS in a time-to-event analysis in the L19TNF plus Doxorubicin control group (Arm 2) versus the Doxorubicin alone treatment group (Arm 1).

    Time frame: From randomization up to week 72

Secondary outcomes

  1. Overall survival (OS)

    Overall survival (OS) in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1) will be evaluated in time to event analysis.

    Time frame: From week 1 up to week 72, every 6 weeks; from week 73 up to week 144, every 12 weeks;

  2. Overall response rate (ORR)

    Overall Response Rate (ORR) assessed by BIRC, i.e. rate of CR and PR of L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).

    Time frame: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.

  3. Duration of response (DOR)

    Duration of Response (DOR) assessed by BIRC in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).

    Time frame: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.

  4. Progression-free survival (PFS) rate

    PFS rate of L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).

    Time frame: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.

  5. Overall survival (OS) rates

    Overall survival (OS) rates in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).

    Time frame: From week 1 up to week 144.

  6. Number of patients with adverse events (AEs).

    Time frame: From week 1 up to week 72.

  7. Percentage of participants with worst on-study hematological and chemistry abnormalities.

    Time frame: From week 1 up to week 72.

  8. Percentage of participants with Electrocardiogram (ECG) and Echocardiogram (ECHO) abnormality findings.

    Time frame: From week 1 up to week 72, every 6 weeks.

  9. Number of Participants With Clinically Significant Abnormalities in Vital Signs (Systolic and Diastolic Blood Pressure, Temperature, Heart Rate).

    Time frame: From week 1 up to week 72.

  10. Number of Participants With Clinically Significant Physical Examination Abnormalities (General Appearance, Skin, Eyes, Ears-Nose-Throat, Breast, Head and Neck, Lungs, Heart, Abdomen, Lymph Nodes, Musculoskeletal)

    Time frame: From week 1 up to week 72.

  11. Human anti-fusion protein antibodies (HAFA) levels against L19TNF.

    Time frame: At day 1 of week 1 and week 2; at day 1 from week 4 up to week 18, every 3 weeks; at week 22-23 (EoT); at week 23-24 (first follow-up visit)

  12. Maximum drug concentration [Cmax].

    Pharmacokinetics assessment of L19TNF through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  13. Time to reach maximum drug concentration [Tmax].

    Pharmacokinetics assessment of L19TNF through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  14. Terminal half-life [t1/2].

    Pharmacokinetics assessment of L19TNF through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  15. Area under the drug concentration-time curve, extrapolated to infinity [AUC].

    Pharmacokinetics assessment of L19TNF through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  16. Maximum drug concentration [Cmax].

    Pharmacokinetics assessment of doxorubicin through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  17. Time to reach maximum drug concentration [Tmax].

    Pharmacokinetics assessment of doxorubicin through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  18. Terminal half-life [t1/2].

    Pharmacokinetics assessment of doxorubicin through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

  19. Area under the drug concentration-time curve, extrapolated to infinity [AUC].

    Pharmacokinetics assessment of doxorubicin through blood sampling.

    Time frame: At day 1, 2 ,3 and 5 of week 1

07

Study locations

8 of 8 sites recruiting
  • Mayo Clinic Hospital
    Phoenix, Arizona 85054, United States
    Recruiting
    • Mahesh Seetharam, MD · Contact
  • Sarcoma Oncology Research Center (SORC) Cancer Center of Southern California
    Santa Monica, California 90403, United States
    Recruiting
    • Sant P Chawla, MD · Contact
  • Mayo Clinic Hospital
    Jacksonville, Florida 32224, United States
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
    • Scott Okuno, MD · Contact
  • Washington University
    Saint Louis, Missouri 63110, United States
    Recruiting
    • Mia Weiss, MD · Contact
  • Rutgers Cancer Institute of New Jersey 195 Little Albany Street New Brunswick, NJ 08901 Room 2031
    New Brunswick, New Jersey 08901, United States
    Recruiting
    • Sarah Weiss, MD · Contact
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43202, United States
    Recruiting
    • David A Liebner, MD · Contact
  • Seattle Cancer Care Alliance 825 Eastlake Ave. E. Seattle, WA 98109 Mail Stop CE2-128
    Seattle, Washington 98109, United States
    Recruiting
    • Lee Cranmer, MD · Contact
08

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

Started Dec 2018 (actual). Primary completion is estimated for Dec 2024, 72 months after the start.

Of 41 phase 2 interventional studies under Leiomyosarcoma, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 80. This study's planned 72 months is above that.

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

Registered
Jan 12, 2018
First posted
Feb 5, 2018
StartActual
Dec 27, 2018
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2025
Last update
Oct 10, 2023
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 Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03420014
Lead sponsor
Philogen S.p.A.
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Dec 27, 2018
Primary completion
Dec 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 10, 2023

Study contacts

Teresa Hemmerle, PhD
Contact
regulatory@philogen.com
+39 057717816
Serena Bettarini, Dr
Contact
regulatory@philogen.com
+39 057717816
Scott H. Okuno, M.D.
principal investigator · Mayo Clinic, Rochester, MN

Oversight

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

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Studies of the drugs tested here: Onfekafusp alfa · Doxorubicin

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