None listed
Conditions
Interventions
GROUP 1 Type of group
1) Induction phase: This group will be treated with MDX-010 (BMS-734016) 10 mg / kg IV in 4 unique doses every three Weeks (Weeks 1, 4, 7 and 10). + Budesonide for 16 weeks, at a dose of 9 mg QD PO until Week 12, the dose will be reduced to 6 mg QD until Week 14 and finally to 3 mg QD until Week 16.
2) Maintenance Phase: Patients who do not present intolerable progression or toxicity will receive additional single doses of MDX-010 (BMS-734016) 10 mg / kg IV every 12 Weeks (Weeks 24, 36, 48)
1) Induction phase: This group will be treated with MDX-010 (BMS-734016) 10 mg / kg IV in 4 unique doses every three Weeks (Weeks 1, 4, 7 and 10). + Budesonide Placebo QD PO for 16 weeks.
2) Maintenance Phase: Patients who do not present intolerable progression or toxicity will receive additional single doses of MDX-010 (BMS-734016) 10 mg / kg IV every 12 Weeks (Weeks 24, 36, 48)
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: a) Written informed consent, voluntarily signed and dated. It must be obtained before performing the procedures related to the protocol. b) Able to comply with visits / procedures required by the protocol. c) Life expectancy of at least 4 months. d) ECOG 0-1 performance status score. e) Histological or cytological diagnosis of non-resectable malignant melanoma of Stage III or IV. f) Disease susceptible of measurement. g) It must have been at least 4 weeks since the last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery and the beginning of the protocol therapy. h) The toxicity related to the previous therapy must have returned to ≤ grade 1, to the baseline or be considered irreversible. i) Men and women 18 years and older. Women of childbearing age (WOCBP) should be using an adequate contraceptive method. The WOCBP must have a negative pregnancy test within 72 hours prior to the start of the study medication. j) Values ​​adequate for initial laboratory tests.
Exclusion criteria
Exclusion criteria: a) WOCBPs that are not willing or able to use an acceptable method to avoid pregnancy during the entire study period and for at least 12 weeks after the study. b) WOCBPs that use a prohibited method of contraception. c) Women who are pregnant or breastfeeding. d) Women with a positive pregnancy test at the time of enrollment or before administration of the study drug. e) Sexually active fertile men who are unwilling or unable to use a barrier contraceptive or whose partners are WOCBP who do not use a method of birth control from the moment of enrollment and for 12 weeks after participation in the study. f) Any other malignant disease that the patient has suffered for less than 5 years. g) Ocular melanoma. h) Central nervous system (CNS) metastasis untreated and active. i) Autoimmune disease. j) Any underlying medical condition, which makes the administration of the study drug dangerous or hinders the interpretation of adverse events. k) Positive screening tests for HIV, HepB and HepC. If the positive results are not indicative of true active or chronic infection, the patient can be admitted after being discussed and agreed with the BMS Medical Monitor. l) Therapies and / or prohibited medications. m) Exposure to any of the products under investigation within 4 weeks prior to Day 1 of the treatment. n) Pre-treatment with an anti-CLTA-4 antibody. o) Use of any immunosuppressive treatment within 4 weeks prior to Day 1 of treatment. p) Concomitant therapy with any of the following: IL-2, interferon or other anti-melanoma immunotherapy regimens that are not in the study; cytotoxic chemotherapy; immunosuppressive agents; other therapies in research or the chronic use of systemic corticosteroids. q) Concomitant chemotherapy is prohibited. r) Prisoners or patients who are required to be detained for the treatment of either a psychiatric or physical illness should not be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Diarrhea will be evaluated (defined, either as the first watery stool or increased frequency above the baseline with urgency or nocturnal movement of the bowel or bleeding stool), infectious or alternate etiologies will be ruled out and classified according to the Common Terminology Criteria for Adverse Events (CTCAE), v3.0, of the National Cancer Institute (NCI). Measure:Index of diarrhea grade 2/3/4. Timepoints:Before starting the study and in weeks 1, 4, 7, 8-9, 10, 12, 16, 20, 24, 40, 36, 42 and 48. ; Outcome name:Clinical evaluation: A complete physical examination and evaluation of vital signs will be performed Evaluation of adverse events and their classification according to the Common Terminology Criteria for Adverse Events (CTCAE), v3.0, of the National Cancer Institute (NCI). Measure:Safety of treatment: Adverse events. Measurements of vital signs. Results of physical examination. Results of laboratory tests. Timepoints:Evaluation of adverse events: Before starting the study and in weeks 1, 4, 7, 8-9, 10, 12, 16, 20, 24, 40, 36, 42 and 48. Physical exam: Before starting the study and in weeks 1, 4, 7, 10, 12, 24, 36 and 48. vital signs: Before starting the study and in weeks 1, 4, 7, 10, 12, 16, 20, 24, 40, 36, 42 and 48. Laboratory tests: Before starting the study and in weeks 1, 4, 7, 10, 12, 24, 40, 36 and 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Determination of the tumor response index: To evaluate the response to the tumor, images (CT, MRI) of the thorax, abdomen and pelvis are required at each tumor evaluation visit, regardless of the location of the known metastases. The CNS images should be obtained when clinically required by the appearance of relevant symptoms. In addition, visible lesions of the skin will be measured clinically using standardized photographs. 2) Determination of the duration of the best objective response: Where the objective response is defined as the total number of patients with the best CR response (complete response, complete disappearance of all tumor lesions for at least 4 weeks) or PR ( Partial response, decrease of 50% or more in the sum of the products of the two largest perpendicular diameters of all index injuries) divided by the total number of patients. Using CT, MRI and photographs of the lesions. 3) Determination of time to obtain the best objective response: Clinical evaluation of imaging and photographs. Measure:1) Response rate. 2) Duration of the best objective response. 3) Time until obtaining the best objective response. Timepoints:Obtaining photographic images, CT or MRI: Before starting treatment and in weeks 12, 16, 20, 24, 30, 36, 42 and 48. ; Outcome name:1) Determination of survival without progression of the disease: Clinical evaluation of patients who do not show clinical or imaging progression of the disease. 2) Determination of overall survival: Calculation of the number of patients who survived compared to the total number of randomized patients 3) Determination of the control index of the disease: Defined as the total number of patients with a better response of the Complete, partial or stable disease divided by the total number of patients. It will be evaluated by CT, MRI or photographs of the lesions Measure:1) Survival without progression of the disease. 2) Global survival. 3) Disease control | — |
Countries
Canada, Israel, Italy, Peru, United Kindgdom, United States
Outcome results
None listed