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A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy (NCT02771340)

The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.
  • Biological: ICON-1
    Intravitreal injection of ICON-1
    • human Immuno-conjugate 1
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Males or females of any race at least 18 years of age
  • Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
  • Planned enucleation or brachytherapy of the study eye due to uveal melanoma
Exclusion Criteria:
  • Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
  • Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
  • Woman who is pregnant or lactating

8 locations

United States (8)
  • Not specified
    San Francisco, California, United States, 94109
  • Not specified
    Denver, Colorado, United States, 80401
  • Not specified
    Leawood, Kansas, United States, 66211
  • Not specified
    Boston, Massachusetts, United States, 02114
  • Not specified
    Grand Rapids, Michigan, United States, 49546
  • Not specified
    Royal Oak, Michigan, United States, 48073
  • Not specified
    Portland, Oregon, United States, 97239
  • Not specified
    Philadelphia, Pennsylvania, United States, 19107
Status:
completed
Type:
Interventional
Phase:
Start:
30 April, 2016
Updated:
15 January, 2018
Participants:
10
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