None listed
Conditions
Interventions
Group A Type of group
Group A will enter the reinduction phase to receive ipilimumab (4 individual doses of ipilimumab at 3-week intervals [Weeks 1, 4, 7 and 10]) and continuous tumor evaluations until week 24, disease progression (PD) , unacceptable toxicity, withdrawal of consent or closure of the study. The tumor response and tolerance of the patient to ipilimumab will determine whether the patient will be allowed to continue in the maintenance phase and as a what. This study design requires that all patients in G
Group C will enter the monitoring phase. Group C patients will not receive any additional study treatment but will continue to follow up. This study facilitates continuous monitoring of patients previously treated with ipilimumab in previous / original studies that have been completed.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: • Have experienced PD after clinical benefit; and • Have achieved a clinical benefit (SD, PR or CR) in Week 12 or after it in a previous / original study or, only for Protocol CAI84022, have manifested disease progression before Week 12 or after clinical benefit (SD, PR or CR) in the previous / original protocol. • Patients who received any dose of ipilimumab in a previous / original study that has been completed; and have • Achieved an SD or improved (PR or CR), without progression or relapse at the time of admission to the complementary study. • Patients who received any dose of ipilimumab in a previous / original study that has been completed; • They were in the follow-up phase of the previous / original study; .
Exclusion criteria
Exclusion criteria: • Have not manifested unacceptable toxicity that requires discontinuation of ipilimumab; • They did not consider themselves eligible to enter Groups A or B or refused treatment as patients of Groups A or B at the time of selection in this complementary study, but gave their consent for follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The best overall response will be evaluated for patients receiving reinduction. BOR is the designation of the best confirmed response within the period after the first reinduction, recorded between the beginning of the first reinduction and the beginning of the second or subsequent therapy (except for local palliative radiotherapy for painful bone lesions) - whichever comes first - in each patient of the study. Measure:Best overall response (BOR) per patient (including all time points) Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The BORR is defined by treatment group as the total number of patients in the group whose BOR is CR or PR, divided by the total number of patients enrolled in the group. Measure:Overall best response rate (BORR) Timepoints:During the study ; Outcome name:The duration of a patients BOR is defined as the time between the date on which the first measurement criterion was met for the PR or CR BOR (whichever state was registered first) and the date of disease progression or Death, whichever comes first. Measure:Duration of the best objective response Timepoints:During the study ; Outcome name:The time to reach the BOR is defined as the time between the date of the first dose of ipilimumab in the first reinduction until the measurement criteria of the PR or CR BOR are met (whichever is recorded first). Measure:Time to the best objective response Timepoints:During the study ; Outcome name:The disease control rate is defined by treatment group as the total number of patients in the group with CRB, PR or SD BOR, divided by the total number of patients enrolled in the group. Measure:Disease control rate Timepoints:During the study ; Outcome name:Progression-free survival (PFS) will be calculated for (1) Group B patients (i.e. patients receiving maintenance treatment at baseline) and Group C patients without progression (i.e. patients without progression in follow-up) and (2) patients receiving the first reinduction. Measure:Progression Free Survival (PFS) Timepoints:During the study | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Mexico, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kindgdom, United States
Contacts
Public ContactJuanita Aching
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed