None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Dacarbazine, at a dose of 850 mg / m2, in IV infusion, every 3 weeks, until week 22, until the progression of the disease, unacceptable toxicity or withdrawal of consent + Ipilimumab, at a dose of 10 mg / kg, in IV infusion, with a single dose in weeks 1, 4, 7 and 10, up to a total of four separate doses, until the progression of the disease, unacceptable toxicity or withdrawal of consent. From week 24 (Maintenance phase), Ipilimumab will be administered, in the s
This group will be treated with Dacarbazine, at a dose of 850 mg / m2, in IV infusion, every 3 weeks, until week 22, until the progression of the disease, unacceptable toxicity or withdrawal of consent + Ipilimumab Placebo, in IV infusion, with a single dose in weeks 1, 4, 7 and 10, up to a total of four separate doses, until the progression of the disease, unacceptable toxicity or withdrawal of consent. From week 24 (Maintenance Phase), Ipilimumab Placebo will be administered, in the same dose,
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Disposition and ability to give written informed consent. 2) Have a histological diagnosis of malignant melanoma. 3) Stage III untreated and unresectable melanoma with macroscopic lymph nodes N3 or metastasis in transit / satellites or stage IV melanoma. 4) Measurable / evaluable disease within 28 days before the first dose of the experimental drug. 5) Life expectancy> 16 weeks. 6) General condition according to the ECOG scale of 0 or 1. 7) Have a complete set of digital images and radiographic images of the lesions in the initial moment. 8) Have the required values for the initial laboratory tests. 9) Negative screening tests for HIV, hepatitis B and hepatitis C. 10) Accessible for treatment and monitoring. 11) Men and women of> 18 years.
Exclusion criteria
Exclusion criteria: 1) WOCBPs that are not willing or able to use an acceptable method to prevent pregnancy during the entire study period and up to 8 weeks after the study. 2) Women who are pregnant or breastfeeding. 3) Women with a positive pregnancy test. 4) Sexually active fertile men whose partners are WOCBP, unless they use adequate contraceptive methods. 5) Evidence of cerebral metastases in brain images. 6) Any other neoplasm of which the patient has been free of disease for less than 5 years. 7) Ocular or primary mucosal melanoma. 8) Autoimmune disease. 9) Any underlying medical or psychiatric illness. 10) Previous or concomitant treatment with some antineoplastic, immunosuppressive agents, surgery or radiotherapy, other experimental anticancer therapies, or the chronic use of corticosteroids. 11) Any treatment with non-oncological vaccines used for the prevention of infectious diseases. 12) Previous treatment with a CD137 agonist or a CTLA-4 inhibitor or agonist. 13) Previous participation in another clinical trial with ipilimumab. 14) Treatment with other experimental products within 4 weeks prior to randomization in this study. 15) Prisoners or persons who are mandatorily detained for the treatment of any psychiatric or physical illness should not be randomized in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of the time between the date of randomization and the date of the progression of the disease or death. Progressive disease is defined as: 1) Indexed injuries: An increase of at least 25% in the sum of the products of all the indexed injuries and / or the appearance of any new lesion. 2) Non-Indexed Lesions: Appearance of any new lesion and / or unequivocal progression of non-indexed injuries. Measure:Survival without progression (PFS). Timepoints:From randomization, to an approximate follow-up of 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Determination of the time between the randomization date and death. Criterion 2: Determination of the probability that a patient will survive one year after the randomization date. Criterion 3: Determination of the time between the date of randomization and the date of the progression of the disease or death. Criteria 4, 6 and 7: The Overall Better Response Rate (BORR) will be determined by counting the total number of patients whose Best Overall Response (BOR) is: Complete Response (CR) or Partial Response (PR), divided by the total number of patients randomized in the branch. Criterion 5: Determination of the total number of patients randomized with BOR of CR, PR or stable disease (SD). Measure:1) Overall Survival (OS). 2) Survival rate per year. 3) PFS to week 12. 4) BORR. 5) Rate of disease control. 6) Time until the BOR. 7) Duration of the BOR. Timepoints:Criterion 1 and 2: A 1 year. Criterion 3: Week 12. Criteria 4-7: From randomization, to an approximate follow-up of 5 years. ; Outcome name:Criterion 1: Medical evaluation of adverse events, applying the criteria of the CTCAE of INC version 3.0. Criterion 2: Panels of serum chemistry and hematology. Measure:Security: 1) Adverse events. 2) Laboratory results. Timepoints:Criterion 1: Weeks 1, 4, 7, 8, 9, 10, 12, 13, 16, 19, 20, 22, 24, 30, 36, 42, 48 and at the end of the study. Criterion 2: Weeks 1, 4, 7, 10, 12, 24, 36, 48 and at the end of the study. ; Outcome name:Serum concentration of ipilimumab (MDX-010). Measure:Pharmacokinetics. Timepoints:Weeks 1, 7, 8, 9 and 10. ; Outcome name:Questionnaire C30 on quality of life (QLQ-C30) of the European Organization for cancer research and treatment (EORTC). Measure:Quality of life. Timepoints:Weeks 1, 4,7, 10, 12, 24, 36 and during follow-up. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, South Africa, Spain, Switzerland, Ukraine, United Kindgdom, United States
Outcome results
None listed