Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
Summary
The purpose of this study is to assess the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with ipilimumab in subjects with unresectable Stage III or Stage IV malignant melanoma
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Malignant Melanoma
Intervention
BMS-936558 (MDX1106-04), Ipilimumab
Location
Local Institution
Los Angeles
California
United States
90025
Status
Recruiting
Source
Bristol-Myers Squibb
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01024231
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Melanoma, Amelanotic
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)
Iris Neoplasms
Tumors of the iris characterized by increased pigmentation of melanocytes. Iris nevi are composed of proliferated melanocytes and are associated with neurofibromatosis and malignant melanoma of the choroid and ciliary body. Malignant melanoma of the iris often originates from preexisting nevi.
Hutchinson's Melanotic Freckle
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.
Cysteinyldopa
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.
Dysplastic Nevus Syndrome
Clinically atypical nevi (usually exceeding 5 mm in diameter and having variable pigmentation and ill defined borders) with an increased risk for development of non-familial cutaneous malignant melanoma. Biopsies show melanocytic dysplasia. Nevi are clinically and histologically identical to the precursor lesions for melanoma in the B-K mole syndrome. (Stedman, 25th ed)
Clinical Trials
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...
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...
Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma
The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely...
Study of Ipilimumab to Treat Melanoma in Patients With Brain Metastases
To determine if melanoma brain metastases will respond to ipilimumab treatment while being generally well tolerated
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unr...
PubMed Articles
Immunomodulatory therapy for melanoma: Ipilimumab and beyond.
In 2011, the U.S. Food and Drug Administration approved the first new therapy for melanoma in more than a decade, ipilimumab (Yervoy). Ipilimumab is a novel antibody that blocks cytotoxic T lymphocyte...
Diarrhea from Ipilimumab in Melanoma.
To the Editor: Hodi and colleagues (Aug. 19 issue)(1) report that among patients with previously treated metastatic melanoma, overall survival was increased with ipilimumab, with or without a glycopro...
Diarrhea from Ipilimumab in Melanoma.
To the Editor: Hodi and colleagues (Aug. 19 issue)(1) report that among patients with previously treated metastatic melanoma, overall survival was increased with ipilimumab, with or without a glycopro...
Improved survival with ipilimumab in patients with metastatic melanoma.
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma Original Article, N Engl J Med 2010:363;711-723. The disclosure statement (page 721) should have included the following: "Dr. van...
Association between ipilimumab and celiac disease.
A 62-year-old man with chemotherapy-naive, castration-resistant metastatic prostate cancer presented with refractory diarrhea despite prolonged high-dose corticosteroid treatment after receiving 3 dos...
