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Clinical Trial 19407

Cancer Type: Cutaneous
Interventions:Daromun; Not Applicable

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Jonathan Zager

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

The purpose of this clinical study is to test efficacy of Daromun neoadjuvant treatment followed by surgery to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma participants with respect to the standard of care (surgery alone).

Objective

Primary Objective: Efficacy of Daromun neoadjuvant treatment followed by surgery 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 alone). Secondary Objectives: The key secondary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery improves in a statistically significant manner the overall survival (OS) of patients with resectable Stage IIIB or C melanoma patients with respect to the standard of care (surgery alone). Other secondary objectives include improvement of RFS as determined by the local investigator, local recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) as well as demonstration of safety and tolerability of the Daromun treatment.

Inclusion Criteria

  • Diagnosis of clinical stage IIIB and IIIC metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable).
  • 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
  • Adequate organ function
  • Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg, anti-HBsAg Ab and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (e.g. anti-HBs Ab with no history of vaccination and/or anti-HBc 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 less than or equal to 1
  • 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.
  • Male participants with WOCBP partners must agree to use simultaneously two acceptable methods of contraception 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.

    • Exclusion Criteria

  • 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, 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
  • 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 less than or equal to 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 requires or is 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

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