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Experimental shot before surgery may keep melanoma from coming back

NCT ID NCT03567889

Disease control Sponsor: Philogen S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether injecting Daromun directly into melanoma tumors before surgery can help prevent the cancer from returning. About 186 people with stage IIIB/C/D melanoma will either get Daromun injections plus standard surgery and follow-up therapy, or just surgery and follow-up therapy. The main goal is to see if the Daromun group has a longer time without the cancer coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Daromun (a combination of two immune-targeting proteins, L19IL2 and L19TNF)
What this could lead to
If successful, this approach could reduce the chance of melanoma returning after surgery, offering a new treatment option for advanced stage III patients.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The treatment involves injections directly into tumors, which may cause local side effects, and the benefit over standard care is still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2018

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of clinical stage IIIB, IIIC, and IIID (AJCC 8th edition) locoregional melanoma that is eligible for complete surgical resection of all metastases (surgically resectable). 2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. 3. Prior anti-tumor treatment for the primary melanoma lesion, including surgery and approved adjuvant treatments (e.g., radiotherapy, immune checkpoint inhibitors, BRAF/MEK inhibitors, etc.) is allowed. Before enrollment in the study, a wash-out period of 6 weeks is required and toxicities from prior treatments should be resumed to Grade ≤1. 4. Males or females, age ≥ 18 years. 5. ECOG Performance Status/WHO Performance Status ≤ 1. 6. Life expectancy of \> 24 months. 7. Absolute neutrophil count \> 1.5 x 109/L. 8. Hemoglobin \> 9.0 g/dL. 9. Platelets \> 100 x 109/L. 10. Total bilirubin ≤ 30 μmol/L (or ≤ 2.0 mg/dl). 11. ALT and AST ≤ 2.5 x the upper limit of normal (ULN). 12. Serum creatinine \< 1.5 x ULN. 13. LDH serum level ≤ 1.5 x ULN. 14. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e. positive anti-HBsAg with not vaccination and/or positive anti-HBcAg Ab), negative serum HBV-DNA is also required. 15. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above. 16. All women of childbearing potential (WOCBP) must have negative pregnancy test results at the screening. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods. WOCBP and effective contraception methods are defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group 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. Pregnancy test will be repeated at the safety visit (only WOCBP and only for patients in Arm 1). 17. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration. 18. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 19. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria 1. Uveal melanoma or mucosal melanoma 2. Evidence of distant metastases at screening. 3. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except: cervical carcinoma in situ, curatively treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry. 4. Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. 5. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. 6. Inadequately controlled cardiac arrhythmias including atrial fibrillation. 7. Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria). 8. LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator. 9. Uncontrolled hypertension. 10. Ischemic peripheral vascular disease (Grade IIb-IV). 11. Severe diabetic retinopathy. 12. Active autoimmune disease. 13. History of organ allograft or stem cell transplantation. 14. Recovery from major trauma including surgery within 4 weeks prior to enrollment. 15. Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product. 16. Breast feeding female. 17. Anti-tumor therapy (except small surgery) within 4 weeks before enrollment. 18. Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment. 19. Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment. 20. Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis will be evaluated case by case with the Sponsor for inclusion/exclusion in the study. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criteria. 21. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol. 22. Previous enrolment and randomization in the same study.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma stage IIIB Melanoma stage IIIC Melanoma stage iiid

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ambulatory Care Center at NYC Langarone Health

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Duke University Medical Center - Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • El Hospital Universitario De Gran Canaria Dr. Negrin

    RECRUITING

    Las Palmas de Gran Canaria, Canarie, 35010, Spain

  • Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Fox Chase Cancer Center 333 Cottman Avenue

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fundacion Onkologikoa Fundazioa

    RECRUITING

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, Murcia, 30120, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Regional de Málaga

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • Hospital Universitario Virgen De La Macarena

    ACTIVE_NOT_RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Barcelona, 08025, Spain

  • Huntsman Cancer Institute, University of Utah 2000 Circle of Hope

    RECRUITING

    Salt Lake City, UT, Utah, 84112, United States

  • Hôpitaux Universitaires de Genève

    ACTIVE_NOT_RECRUITING

    Geneva, Canton of Geneva, 1205, Switzerland

  • Insel Gruppe AG

    ACTIVE_NOT_RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

  • Istituto Oncologico della Svizzera Italiana

    RECRUITING

    Bellinzona, Bellinzona, 6500, Switzerland

  • Kantonsspital St.Gallen

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Madrid, Madrid, 28033, Spain

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center - Main Campus

    RECRUITING

    Ney York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Penn State Cancer Institute

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Rush University Medical Center

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60612, United States

  • Rutgers Cancer Institute, 195 Little Albany Street

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd.

    ACTIVE_NOT_RECRUITING

    Easton, Pennsylvania, 18045, United States

  • The University of Texas M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868-3201, United States

  • UC San Diego Moores Cancer Center

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92093, United States

  • University of Iowa Hospitals and Clinics

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52242, United States

  • Universitätsspital Basel

    ACTIVE_NOT_RECRUITING

    Basel, Basel, 4031, Switzerland

  • Universitätsspital Zürich (USZ)

    RECRUITING

    Zurich, Canton of Zurich, 8091, Switzerland

  • VCU - McGlothlin Medical Education Center

    RECRUITING

    Richmond, Virginia, 980037, United States

  • Winship Cancer Institute, Emory university

    RECRUITING

    Atlanta, Georgia, 30322, United States

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