Melanoma MedDRA version: 6.1 Level: HLT Classification code 10027156
Conditions
Interventions
Product Name: BMS-734016
Pharmaceutical Form: Solution for infusion
Current Sponsor code: MDX-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Ent
Sponsors
BRISTOL-M.SQUIBB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To estimate the rate of grade 2/3/4 diarrhea in patients treated with intravenous MDX-010 BMS-734016 at 10 mg/kg when given with either prophylactic oral budesonide Entocort EC or placebo. To evaluate the following in this patient population i Safety; ii Best objective response rate best response of CR or PR ; iii Progression Free Survival PFS Rate at Week 12; iv Disease control rate best response of CR PR SD ; v Progression free survival PFS ; vi Overall survival OS ; vii Duration of best objective response; and viii Time to best objective response. 2 To estimate the rates of other drug-related adverse events when MDX-010 BMS-734016 is given with prophylactic oral budesonide Entocort 63195; EC or placebo. 3 To identify potential predictors of response by analyzing messenger RNA mRNA expression, protein profiling and immunologic profiling in pre-treatment optional tumor biopsies. 4 To compare pre- and post-treatment mRNA expression, protein profiling and immunologic profiling in tumor specimens optional and peripheral blood mononuclear cells PBMCs .;Secondary Objective: To evaluate the following in this patient population i Safety; ii Best objective response rate best response of CR or PR ; iii Progression Free Survival PFS Rate at Week 12; iv Disease control rate best response of CR PR SD ; v Progression free survival PFS ; vi Overall survival OS ; vii Duration of best objective response; and viii Time to best objective response. 2 To estimate the rates of other drug-related adverse events when MDX-010 BMS-734016 is given with prophylactic oral budesonide Entocort 63195; EC or placebo. 3 To identify potential predictors of response by analyzing messenger RNA mRNA expression, protein profiling and immunologic profiling in pre-treatment optional tumor biopsies. 4 To compare pre- and post-treatment mRNA expression, protein profiling and immunologic profiling i | — |
Countries
Italy, United Kingdom
Outcome results
None listed