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Immunogenicity and Biomarker Analysis of Neoadjuvant Ipilimumab for Melanoma

2014-08-27 03:19:30 | BioPortfolio

Summary

Ipilimumab is a manufactured monoclonal antibody, much like the antibodies usually made by the human body to fight off infection; however it is not known why the human body does not "fight off" a cancerous tumor. The idea behind developing this experimental drug is to stimulate the immune system to make antibodies to kill cancer cells. This research study is considered "experimental" because it has not received approval from the Food and Drug Administration (FDA) for the treatment of this type of cancer.

This monoclonal antibody has been specifically made to block Cytotoxic T Lymphocyte Antigen 4 (CTLA4), which is a protein found on cells of the immune system. CTLA4 seems to slow down the immune response, so blocking it with an anti-CTLA4 antibody may make the immune response more active. The purpose of this study is to see if Ipilimumab affects the response of the patient's immune system toward their cancer.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

ipilimumab

Location

University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute
Pittsburgh
Pennsylvania
United States
15232

Status

Recruiting

Source

University of Pittsburgh

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:30-0400

Clinical Trials [1176 Associated Clinical Trials listed on BioPortfolio]

A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE 301)

A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

The primary objective of the study is to provide treatment with ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who hav...

Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimu...

Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -i...

Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma

The purpose of this study is to assess the safety and tolerability of treatment with Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV melanoma.

PubMed Articles [875 Associated PubMed Articles listed on BioPortfolio]

Economic Evaluation of Talimogene Laherparepvec Plus Ipilimumab Combination Therapy vs Ipilimumab Monotherapy in Patients With Advanced Unresectable Melanoma.

A phase 2 trial comparing talimogene laherparepvec plus ipilimumab vs ipilimumab monotherapy in patients with advanced unresectable melanoma found no differential benefit in progression-free survival ...

Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain.

Brain metastases are a common cause of disabling neurologic complications and death in patients with metastatic melanoma. Previous studies of nivolumab combined with ipilimumab in metastatic melanoma ...

Ipilimumab for the treatment of advanced melanoma in six kidney transplant patients.

Immune checkpoint inhibitors are new therapeutic options for metastatic melanoma, but little data is available in organ transplant recipient populations. Six French patients, 3 men and 3 women, mean a...

Efficacy and safety of nivolumab in combination with ipilimumab in Japanese patients with advanced melanoma: An open-label, single-arm, multicentre phase II study.

The aim of the study was to evaluate the efficacy and safety of nivolumab combined with ipilimumab in treatment-naïve Japanese patients with advanced melanoma.

Granulomatous dermatitis associated with ipilimumab therapy (Ipilimumab associated granulomatous dermatitis).

Ipilimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen (CTLA-4) approved for treatment of metastatic melanoma. The most commonly reported side effects are imm...

Medical and Biotech [MESH] Definitions

An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

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