A Phase I Trial of Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|