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Tests treatment safety and results for Melanoma Stage IIIB
Official title Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
ClinicalTrials.gov ID: NCT03567889
What this study is testing
What is Daromun?
Daromun is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for melanoma stage iiib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of clinical stage IIIB, IIIC, and IIID (AJCC 8th edition) locoregional melanoma that is eligible...
- Eligible people must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or...
- Prior anti-tumor treatment for the primary melanoma lesion, including surgery and approved adjuvant treatments (e.g., radiotherapy, immune checkpoint...
- Males or females, age ≥ 18 years.
- ECOG Performance Status/WHO Performance Status ≤ 1.
You likely can't join if
- 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...
- Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator...
- 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.
See the full eligibility criteria
- 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...
- Eligible people 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...
- 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...
- Males or females, age ≥ 18 years.
- ECOG Performance Status/WHO Performance Status ≤ 1.
- Life expectancy of \> 24 months.
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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.
- 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...
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
- Previous enrolment and randomization in the same study.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Orange, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Rochester, Minnesota, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Ney York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Easton, Pennsylvania, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, UT, Utah, United States
- Richmond, Virginia, United States
- Badalona, Barcelona, Spain
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; La Jolla, California, United States; Orange, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.