The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. This study also seeks to investigate whether using both study drugs lengthens the amount of time before the participants melanoma worsens.
* There are two phases to this research study, Induction Phase and Maintenance Phase. * Induction Phase: Participants will receive ipilimumab by an infusion into a vein or central line at weeks 1, 4, 7 and 10 for a total of 4 infusions. Bevacizumab is also given as an infusion into a vein or central line at weeks 1, 4, 7 and 10 along with ipilimumab and then every 3 weeks by itself. During all cycles of study therapy, the participant will have a physical exam on the first day and undergo blood tests at every study visit. At weeks 1, 4, 7, 10 and 12 a urine sample will be obtained for analysis. * Chest, abdomen and pelvic CT scans will be performed at week 12. If the scans at week 12 show that the participants cancer has remained stable or decreased, they will be asked to have repeat CT scans in three months. * Positron Emission Tomography (PET) scans will be done at week 8 and week 16. * Maintenance Phase: If the scans performed at week 12 show the cancer has improved or stayed the same, then the participant will continue to receive bevacizumab every three weeks and undergo a CT scan every 3 months. Also, every 3 months the participant may be eligible to receive additional doses of ipilimumab in addition to the bevacizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Cohort 1: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)
Cohort 2: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)
Cohort 3: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
To determine the safety, tolerability and maximum tolerated dosing for the combination of bevacizumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma
Time frame: 3 years
To determine the best overall response rate by standard solid tumor response criteria, disease control rate, time to tumor progression, and duration of response for the combination of bevacizumab plus ipilimumab in this patient population
Time frame: 3 years
To perform correlative studies investigating the effects of this combination therapy on antitumor immunity and tumor vasculature
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cohort 4: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)