Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Canno… (NCT01950390) | Clinical Trial Compass
CompletedPhase 2
Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
United States169 participantsStarted 2014-01-24
Plain-language summary
This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
* Untreated or previously received one treatment regimen for measurable unresectable stage III or stage IV melanoma (American Joint Committee on Cancer \[AJCC\] 2010) (for BRAF wild-type, and regardless of human leukocyte antigen \[HLA\] type); untreated or previously received up to two treatment regimens for measurable unresectable stage III or stage IV melanoma (AJCC 2010) (for BRAF mutant, and regardless of HLA type; if 2 prior regimens, one should be a BRAF inhibitor); this does not include any therapies given in the adjuvant setting
* Prior treatment (chemotherapy \[chemo\], radiation, hormone, and immune therapies) must be completed \> 4 weeks prior to randomization (\> 6 weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors)
* Patients who received prior therapy with anthracyclines should have a baseline multigated acquisition scan (MUGA) or echocardiogram (echo) with a normal ejection fraction within 28 days prior to randomization
* Patients must have recovered from any acute toxicity associated with prior therapy by the start of study treatment
* Women must not be pregnant or breast-feeding due to the unknown effects on the fetus or infant; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual o…
What they're measuring
1
Overall Survival (OS)
Timeframe: Time from randomization to death from any cause, assessed up to 5 years