IMCgp100 in Advanced Unresectable Melanoma (NCT01209676) | Clinical Trial Compass
CompletedEarly Phase 1
IMCgp100 in Advanced Unresectable Melanoma
United States1 participantsStarted 2010-09
Plain-language summary
A phase 0, exploratory study of the pharmacodynamics of a single intratumoral dose of IMCgp100, a monoclonal T cell receptor anti-CD3 scFv fusion protein, in subjects with advanced unresectable melanoma to assess the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Six patients will be enrolled to complete the study over approximately 12-15 months.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Histologically confirmed diagnosis of melanoma, with advanced unresectable disease not currently requiring immediate treatment and/or in a window between treatments.
* 2\. Two or more cutaneous or subcutaneous melanoma metastatic lesions 7-15 mm in at least one dimension and amenable to subsequent biopsy.
* 3\. Age 18 years
* 4\. ECOG performance status 0-2
* 5\. Able to understand and to provide written informed consent and willingness to comply with all protocol requirements;
* 6\. Female patients who are not be of childbearing potential as documented by medical history (e.g., tubal ligation or hysterectomy), or be post menopausal with a minimum 1 year without menses or have a negative serum beta human chorionic gonadotropin (HGC) pregnancy test within 48 hours prior to receiving the intratumoral injection and agree to use an acceptable form of birth control, defined as abstinence or use of an intrauterine device (IUD), oral contraceptive, barrier and spermicide, or hormonal implant throughout the study period;
* 7\. Male patients who must agree to use an acceptable form of birth control throughout the study period.
* 8\. Adequate organ system function as evidenced by laboratory values: -Absolute neutrophil count (ANC) greater than or equal to 1.0 X 109/L -Hemoglobin greater than or equal to 9 g/dL -Platelets greater than or equal to 75 X 109/L -Total bilirubin less than or equal to 1.5 mg/dL -AST and ALT less than or equal to 2.5 X ULN ( 2.5 X UL…
What they're measuring
1
Adverse Events as a Measure of Safety and Tolerability