Randomized, double-blind, placebo controlled phase II study comparing the safety of MDX-010 BMS-734016 administered with or without prophylactic oral budesonide Entocort EC in patients with unresectable stage III or IV malignant melanoma. - ND

• Conditions: Melanoma; MedDRA version: 6.1Level: HLTClassification code 10027156

• Registration Number: EUCTR2005-002678-31-IT
• Lead Sponsor: BRISTOL-M.SQUIBB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Signed written informed consent a Voluntary signed and dated institutional review board IRB /independent ethics committee IEC approved informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performing protocol-related procedures that are not part of standard patient care. 2 Target population a Able to comply with visits/procedures required by the protocol. b Life expectancy of at least 4 months. c ECOG performance status score 0-1 Appendix 1 . d Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma excluding ocular melanoma . e Measurable disease as defined in Section 3.3.3.2. f At least 4 Weeks must have elapsed since the last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery and the beginning of protocol therapy. At least 6 Weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. g Toxicity related to prior therapy must either have returned to 8804; grade 1, baseline, or been deemed irreversible. Men and women, ages 18 and above.
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

Sex and Reproductive Status a WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study. b WOCBP using a prohibited contraceptive method. c Women who are pregnant or breastfeeding. d Women with a positive pregnancy test on enrollment or prior to study drug administration. e Sexually active fertile men who are unwilling or unable to use a barrier contraceptive eg, condom or whose partners are WOCBP not using a method of birth control from the time of enrollment and for 12 Weeks after participation in the study. 2 Target Disease Exclusion a Any other malignancy from 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, carcinoma in situ of the cervix. b Ocular melanoma. 3 Medical History and Concurrent Diseases a Active, untreated central nervous system CNS metastasis including metastasis identified during screening MRI or contrast CT . b Autoimmune disease Patients with a history of Inflammatory Bowel Disease are excluded from this study as are patients with a history of autoimmune disease e.g. Systemic Lupus Erythematosus, vasculitis, infiltrating lung disease whose possible progression during treatment would be considered by the Investigator to be unacceptable. Patients with a history of well-controlled and/or clinically manageable autoimmune disease e.g. vitiligo, well-controlled thyroid disease, mild psoriasis may be considered for inclusion in consultation with the BMS Medical Monitor. c 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; d Positive screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can be admitted after discussion with and agreement by the BMS Medical Monitor. Prohibited Therapies and/or Medications a Exposure to any investigational products within 4 Weeks prior to Day 1 of treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified