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Study of the efficacy of intratumoral injections of L19IL2 + L19TNF followed by surgery to prevent or retard appearance of new metastases
EU CTIS ID: 2023-507119-36-00
What this study is testing
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 melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable).
- 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 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
You likely can't join if
- Uveal melanoma or mucosal melanoma
- 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
See the full eligibility criteria
Who can join
- Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable).
- 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 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
- 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
- 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)
What rules you out
- Uveal melanoma or mucosal melanoma
- 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
- Evidence of distant metastases at screening
- Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol
- Previous enrolment and randomization in the same study
- 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, 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.