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Melanoma Stage IIIBPhase 3NeoDREAMNCT03567889

Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients

A Phase 3 study testing Daromun, Surgery and Adjuvant therapy in people with Melanoma Stage IIIB and Melanoma Stage IIIC, run by Philogen S.p.A. at 37 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Daromun, Surgery and Adjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
37 sitesin 3 countries
Study dates
20 Sep 2018to Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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.
  • 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.
  • Males or females, age ≥ 18 years.
  • ECOG Performance Status/WHO Performance Status ≤ 1.
  • Life expectancy of > 24 months.
Show all 19Show fewer
  • Absolute neutrophil count > 1.5 x 109/L.
  • Hemoglobin > 9.0 g/dL.
  • Platelets > 100 x 109/L.
  • Total bilirubin ≤ 30 μmol/L (or ≤ 2.0 mg/dl).
  • ALT and AST ≤ 2.5 x the upper limit of normal (ULN).
  • Serum creatinine < 1.5 x ULN.
  • LDH serum level ≤ 1.5 x ULN.
  • 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.
  • 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.
  • 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).
  • 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.
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Who cannot join

  • Uveal melanoma or mucosal melanoma
  • Evidence of distant metastases at screening.
  • 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.
  • 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.
  • History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
  • Inadequately controlled cardiac arrhythmias including atrial fibrillation.
Show all 22Show fewer
  • Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
  • LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator.
  • Uncontrolled hypertension.
  • Ischemic peripheral vascular disease (Grade IIb-IV).
  • Severe diabetic retinopathy.
  • Active autoimmune disease.
  • History of organ allograft or stem cell transplantation.
  • Recovery from major trauma including surgery within 4 weeks prior to enrollment.
  • Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product.
  • Breast feeding female.
  • Anti-tumor therapy (except small surgery) within 4 weeks before enrollment.
  • Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment.
  • Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment.
  • 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.
  • Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
  • Previous enrolment and randomization in the same study.

Trial locations and contacts

37 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Sheila Dakhel, PhD contact

+41 (0) 43 544 88 02

sheila.dakhel@philogen.com

Concetta Aulicino contact

+39 0577 17 816

regulatory@philogen.com

37 sites in 3 countries

United States19 sites, 13 recruiting

  • Winship Cancer Institute, Emory university

    Atlanta, Georgia, 30322

    Michael Lowe

    Michael Lowe, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Active, not recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Claire Verschraegen

    Claire Verschraegen, MD

    Recruiting

  • Duke University Medical Center - Duke Cancer Center

    Durham, North Carolina, 27710

    Georgia Beasley

    Georgia Beasley

    Recruiting

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

    Easton, Pennsylvania, 18045

    Active, not recruiting

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

    Joseph Drabick

    Joseph Drabick

    Recruiting

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

    Houston, Texas, 77030-4009

    Hussein Tawbi

    Hussein Tawbi

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Active, not recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Active, not recruiting

  • Rutgers Cancer Institute, 195 Little Albany Street

    New Brunswick, New Jersey, 08903

    Adam Berger

    Adam Berger, MD

    Recruiting

  • Ambulatory Care Center at NYC Langarone Health

    New York, New York, 10016

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    Ney York, New York, 10065

    Danielle Bello

    Danielle Bello

    Recruiting

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    Orange, California, 92868-3201

    Active, not recruiting

  • Fox Chase Cancer Center 333 Cottman Avenue

    Philadelphia, Pennsylvania, 19111

    Jeffrey Farma

    Jeffrey Farma, MD

    Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

    Mahesh Seetharam, MD

    Mahesh Seetharam, MD

    Recruiting

  • VCU - McGlothlin Medical Education Center

    Richmond, Virginia, 980037

    Andrew Poklepovic

    Andrew Poklepovic

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Anastasios Dimou, MD

    Anastasios Dimou, MD

    Recruiting

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

    Salt Lake City, UT, Utah, 84112

    John Hyngstrom

    John Hyngstrom

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Jonathan Zager

    Jonathan Zager, MD

    Recruiting

Other trials in United States

Spain12 sites, 10 recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

    José Luis Manzano Mozo, +34615315823, jmanzano@iconcologia.net

    José Luis Manzano Mozo

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

    Margarita Majem Tarruella, +34935565638, MMajem@santpau.cat

    Margarita Majem Tarruella

    Recruiting

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

    Barcelona, Barcelona, 08035

    Eva Muñoz Couselo, +34932746085, emunoz@vhio.net

    Eva Muñoz Couselo

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, Barcelona, 08036

    Josep Malvehy Guilera, +34932275400, jmalvehy@clinic.cat

    Josep Malvehy Guilera

    Recruiting

  • Fundacion Onkologikoa Fundazioa

    Donostia / San Sebastian, Gipuzkoa, 20014

    Karmele Mujika Eizmendi, +34943328315, kmujika@onkologikoa.org

    Karmele Mujika Eizmendi

    Recruiting

  • El Hospital Universitario De Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, Canarie, 35010

    Elena Castro Gonzalez, +34928450658, elenan.castrogonzalez@gmail.com

    Elena Castro Gonzalez

    Recruiting

  • MD Anderson Cancer Center

    Madrid, Madrid, 28033

    Active, not recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Pedro Luis Ortiz Romero, +34913908000, pablo.ortiz@salud.madrid.org

    Pedro Luis Ortiz Romero

    Recruiting

  • Hospital Universitario Regional de Málaga

    Málaga, Malaga, 29010

    Elisabeth Pérez Ruiz, +34951308130, elisaonco@gmail.com

    Elisabeth Pérez Ruiz

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, Murcia, 30120

    Pablo Cerezuela Fuentes, +34968369387, pcerezuelaf@seom.org

    Pablo Cerezuela Fuentes

    Recruiting

  • Hospital Universitario Virgen De La Macarena

    Seville, Sevilla, 41009

    Active, not recruiting

  • Hospital General Universitario de Valencia

    Valencia

    Alfonso Berrocal Jaime, +34963131800, berrocal.alf@gmail.com

    Alfonso Berrocal Jaime

    Recruiting

Other trials in Spain

Switzerland6 sites, 3 recruiting

  • Universitätsspital Basel

    Basel, Basel, 4031

    Active, not recruiting

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, Bellinzona, 6500

    Cristina Mangas

    Cristina Mangas

    Recruiting

  • Insel Gruppe AG

    Bern, Canton of Bern, 3010

    Active, not recruiting

  • Hôpitaux Universitaires de Genève

    Geneva, Canton of Geneva, 1205

    Active, not recruiting

  • Kantonsspital St.Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

    Nikolaus Wagner

    Nikolaus Wagner

    Recruiting

  • Universitätsspital Zürich (USZ)

    Zurich, Canton of Zurich, 8091

    Egle Ramelyte

    Egle Ramelyte

    Recruiting

Other trials in Switzerland

About this study

Official title: An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C/D Melanoma Patients

The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

Read the detailed description

The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of Daromun neoadjuvant intratumoral treatment followed by surgery and adjuvant therapy versus surgery and adjuvant therapy in clinical stage III B/C/D melanoma patients. 186 patients will be randomized in a 1:1 ratio to receive Daromun treatment followed by surgery and adjuvant therapy (Arm 1) or surgery and adjuvant therapy (Arm 2).

In both arms, follow-up for assessing recurrence-free survival will be performed up to five years after randomization. Survival information will also be collected in the following year (up to six years in total after randomization).

This is an open-label study, so there is no blinding.

Patients who successfully complete the screening evaluations and are eligible for participation in the study will be enrolled and randomly assigned (1:1) to two parallel treatment arms: Daromun plus surgery and adjuvant therapy (Arm 1) or surgery and adjuvant therapy (Arm 2).

To ensure a balance across treatment groups, stratified randomization with permuted block will be used and separate randomization list for each subgroup (stratum) will be produced. Patients will be stratified on the basis of the following prognostic factors:

  • Stage of disease (3 levels): Stage IIIB vs. Stage IIIC vs Stage IIID
  • Planned post-surgical adjuvant therapy (2 levels): anti-PD-1 and other adjuvant therapies.

The primary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

Primary endpoint of the study is RFS in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery plus adjuvant therapy control group (Arm 2). Analysis will be based on the "Intention To Treat" population.

The key secondary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the overall survival (OS) of patients with resectable Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

For patients enrolled in both arms, local approved post-surgery adjuvant therapies (as part of the standard of care) are allowed and decided at the investigator's discretion. These include high-dose interferon- α2b, anti-CTLA-4 antibodies (e.g. Ipilimumab), anti-PD1 antibodies (e.g. Nivolumab, Pembrolizumab), targeted therapies (e.g. Dabrafenib + Trametinib), or other new local approved treatments.

Being tested
Daromun, Surgery, Adjuvant therapy
Keywords
Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaromunDrug

    Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks.

  • SurgeryProcedure or surgery

    Patients will receive surgery.

  • Adjuvant therapyDrug

    Patients will receive adjuvant therapy at the investigator's discretion following the surgery.

Study groups in NCT03567889
Study groupRoleWhat they receive
Daromun plus Surgery and Adjuvant therapyExperimentalArm-1 patients will follow these steps: 1. screening period, 2. 4-week open-label treatment period, 3. surgery within a maximum of 4 weeks, 4. adjuvant therapy.
Receives: Drug: Daromun; Procedure: Surgery; Drug: Adjuvant therapy
Surgery and adjuvant therapyActive comparatorArm-2 patients will follow these steps: 1. Screening period, 2. direct surgery within 4 weeks from randomization, 3. adjuvant therapy.
Receives: Procedure: Surgery; Drug: Adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival (RFS)

    Recurrence Free Survival (RFS) in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery and adjuvant therapy control group (Arm 2). Analysis will be performed for the "Intention To Treat" population.

    Measured: From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.

Secondary outcomes (16)

  1. Overall survival (OS)

    Overall survival (OS) in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2), which will be evaluated in time to event analysis as key secondary endpoint.

    Measured: From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first, assessed up to 72 months.

  2. Recurrence free survival (RFS) as determined by the local investigator

    A sensitivity analysis to assess ascertainment bias will be performed on recurrence free survival. For this analysis the primary analysis definition of recurrence will be split into its two components and each will be analyzed separately. The first component/definition will be based on the unblinded assessment performed at the site - any new lesion detected by clinical evaluation which is confirmed by histopathology (biopsy or surgical specimen) and the second component/definition will be based on the assessment of a new lesion detected by allowed imaging modalities in a Blinded Independent Central Review and confirmed, wherever possible, by histological analysis. Each of these components will be analyzed separately using the same statistical model as the primary endpoint. Results from the two component analyses will be compared.

    Measured: From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.

  3. Event-free survival (EFS)

    Event-free survival (EFS) defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related toxicity precluding surgery, treatment-related death, or melanoma-related death, whichever occurs first.

    Measured: From date of randomization until the date of the first event as described above, assessed up to 60 months

  4. Adverse Events (AE)

    Percentage of Patients in Each Treatment Group with AEs, AEs with CTCAE grade ≥3

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the first follow-up visit (up to approximately 5 months).

  5. Immune-related Adverse Events (irAEs)

    Occurrence of immune-related Adverse Events (irAEs)

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).

  6. Drug-Induced Liver Injury (DILI)

    Number of patients with Drug-Induced Liver Injury (DILI)

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).

  7. Adverse Events of Special Interest (AESI)

    Number of patients with Adverse Events of Special Interest (AESI)

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).

  8. Haematological/chemical Laboratory Abnormalities

    Percentage of Subjects with Haematological/chemical Laboratory Abnormalities

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).

  9. Electrocardiogram (ECG) and echocardiogram (ECHO) abnormalities

    Percentage of participants with Electrocardiogram (ECG) and echocardiogram (ECHO) abnormality findings. Data about QT/QTc intervals will be collected and analysed for QT/QTc prolongation potentially caused by treatment.

    Measured: 1) day 0-14 (screening) for both arm; 2) at week 5 (Safety assessment) only for arm 1.

  10. Physical examination

    Number of subjects with a clinically significant change from baseline in physical examination

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)

  11. Concomitant medication

    Number of subject with concomitant medication

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)

  12. Human anti-fusion protein antibodies (HAFA)

    Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF

    Measured: 1) day 0-14 (screening) for arm 1; 2) at week 5 (Safety assessment) for Arm 1; 3) at week 12 (only first follow-up) for Arm 1.

  13. Vital signs (blood pressure)

    Number of subjects with a clinically significant change from baseline in vital signs (blood pressure) by visit

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).

  14. Vital signals (heart rate)

    Number of subjects with a clinically significant change from baseline in vital signs (heart rate) by visit

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)

  15. Vital signals (body temperature)

    Number of subjects with a clinically significant change from baseline in vital signs (body temperature) by visit

    Measured: From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)

  16. Pathological responses

    Pathological responses (categorized into pCR, near-pCR, pPR, pNR, according to INMC criteria) assessed at time of surgical resection.

    Measured: Assessed at the time of surgical resection of the tumor lesions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start20 Sep 2018
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Total patients: approximately 186. Daromun plus surgery and adjuvant therapy treatment group (Arm 1): 93 evaluable patients. Surgery and adjuvant therapy (Arm 2): 93 evaluable patients. Patients enrolled will be randomized to the two different arms of the study.
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567889
Sponsor's protocol ID
PH-L19IL2TNF-01/18
Other IDs
2023-507119-36-00, 2023
Acronym
NeoDREAM
Status last verified
Dec 2025
First submitted
18 May 2018
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.

    PubMed 36648215

  • Miura JT, Zager JS. Neo-DREAM study investigating Daromun for the treatment of clinical stage IIIB/C melanoma. Future Oncol. 2019 Nov;15(32):3665-3674. doi: 10.2217/fon-2019-0433. Epub 2019 Sep 20.

    PubMed 31538818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daromun, Surgery and Adjuvant therapy in people with Melanoma Stage IIIB and Melanoma Stage IIIC, run by Philogen S.p.A. at 37 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sheila Dakhel, PhD (+41 (0) 43 544 88 02, sheila.dakhel@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (RFS) (time frame: From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567889, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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