IMCgp100 in Advanced Unresectable Melanoma

NCT01209676 | Completed Early Phase 1 DMC

• 1 other identifier: UPCC 03610
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma; Advanced Disease; Unresectable

Keywords

melanoma, with advanced unresectable

Outcome Measures

Primary Outcomes (1)

• Adverse Events as a Measure of Safety and Tolerability

  To determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Tumor Lesions, peripheral blood pre- and post-injection will be used to determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma

  15 months

Secondary Outcomes (4)

• Adverse events

  15 months

• Vital signs

  15 months

• PE examinations findings

  15 months

• Peripheral blood samples

  15 months

Study Arms (1)

IMCgp100

EXPERIMENTAL

IMCgp100 will be injected cutaneously or subcutaneously into the metastasis, and peritumoral area if applicable

Drug: IMCgp100 injection

Interventions

IMCgp100 injection DRUG

a monoclonal T cell receptor anti-CD3scFv fusion protein

IMCgp100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically confirmed diagnosis of melanoma, with advanced unresectable disease not currently requiring immediate treatment and/or in a window between treatments.
• \. Two or more cutaneous or subcutaneous melanoma metastatic lesions 7-15 mm in at least one dimension and amenable to subsequent biopsy.
• \. Age 18 years
• \. ECOG performance status 0-2
• \. Able to understand and to provide written informed consent and willingness to comply with all protocol requirements;
• \. 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;
• \. Male patients who must agree to use an acceptable form of birth control throughout the study period.
• \. 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 ULN in the presence of liver metastasis.) -Creatinine less than or equal to 2 mg/dL -TSH within normal limits -INR/PT and PTT less than or equal to 1.3 X ULN

You may not qualify if:

• \. Receive any chemotherapy, immunotherapy, radiation therapy, or other investigational agents (agents part of a research protocol or not approved by the FDA) within 2 weeks prior to injection. A minimum of 14 days is required between last therapy and injection on this study. In addition, any clinically significant drug-related toxicity should have recovered to grade 1 or less (excluding alopecia)
• \. Patients without cutaneous or subcutaneous metastatic lesions;
• \. Cutaneous metastases that have received prior local therapy, such as radiation or isolated limb perfusion.
• \. Pregnancy or breastfeeding
• \. History of autoimmune disease (excluding vitiligo or controlled thyroid disease) or immunodeficiency.
• \. Current treatment with steroids (inhaled, topical or systemic) or other immunosuppressive medications within 2 weeks of injection;
• \. Active uncontrolled infection;
• \. Known HIV positivity;
• \. Uncontrollable seizures;
• \. Known delayed wound healing;
• \. Full dose anticoagulation with heparin, warfarin, or any other anticoagulant within 2 weeks of injection ;
• \. History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting, stroke or TIA within the past 24 weeks.;
• \. Known hypersensitivity of IMCgp100 or any of its components (ie, Tween) ;
• \. Class II, III, or IV heart failure as defined by the New York Heart Association;
• \. Any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giorgos Karakousis, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

US (1)