HLA-A*0201-Positive Patients with Previously Treated, Unresectable Stage III or IV Melanoma
Conditions
Interventions
Product Name: ipilimumab
Product Code: MDX-010
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ipilimumab
CAS Number: 47
Sponsors
Medarex, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologic diagnosis of malignant melanoma; Measureable Stage III or IV melanoma; at least 18 years of age; positive for HLA-A*0201; have demonstrated 1 of the following in response to at least 1 cycle of 1 or more regimens containing 1 or more of the following: IL-2, dacarbazine, temozolamide, fotomustine, and/or carboplatin: 1) relapse following an objective response 2) failed to demonstrate an objective response or 3) inability to tolerate treatment due to unacceptable toxicity; at least 24 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy, and 14 days for gamma knife treatment and recovered from any clinically significant toxicity experienced during treatment; negative pregnancy test; life expectancy 4 months or greater; ECOG of 0 or 1; meet required lab values; and negative HIV, HepB and HepC tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any other prior malignancy for which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or adequately treated carcinoma in situ of the cervix, breast, or bladder; primary ocular melanoma; prior treatment with any cancer vaccine; active, untreated CNS metastasis; prior treatment with an anti-CTLA4 antibody; any active autoimmune disease or a history of autoimmune disease except for patients with vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism; pregnant or nursing; concomitant therapy with IL-2, interferon or other non-study anti-melanoma immunotherapy regimens or other investigational therapies, or chronic use of systemic corticosteroids; any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study in patients with unresectable Stage III or IV melanoma who have been previously treated with other agents, is to compare overall survival of patients administered MDX-010 in combination with gp100 melanoma peptide vaccine versus those administered gp100 melanoma peptide vaccine alone.; Secondary Objective: The secondary objectives of the study include: • Comparison of overall survival of patients administered MDX-010 in combination with gp100 melanoma peptide vaccine vs. those administered MDX-010 monotherapy, and of patients administered vaccine monotherapy vs. those administered MDX-010 monotherapy; • Evaluation of safety; and • Determination of best overall response rate (BORR), major durable response rate, duration of response, progression-free survival, time-to-progression, and health-related Quality of Life. ;Primary end point(s): The primary efficacy endpoint is the comparison of overall survival of patients administered MDX-010 in combination with gp100 melanoma peptide vaccine versus those administered gp100 melanoma peptide vaccine alone. | — |
Countries
Belgium, Germany, Hungary, United Kingdom
Outcome results
None listed