Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery

Completed · Phase 2

Conditions studied: Metastatic Melanoma, Mucosal Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Uveal Melanoma AJCC v7, Unresectable Melanoma

In brief

This randomized phase II trial studies how well nab-paclitaxel and bevacizumab or ipilimumab works as first-line therapy in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop the growth of tumor cells by binding to a protein called vascular endothelial growth factor (VEGF) and by preventing the growth of new blood vessels that tumors need to grow. Ipilimumab blocks a substance called cytotoxic T-lymphocyte-associated antigen-4 (CTLA4) on the surface of T cells and may help the immune system kill cancer cells. It is not yet known whether nab-paclitaxel and bevacizumab is more effective than ipilimumab in treating melanoma.

Key facts

Study ID: NCT02158520
Run by: Academic and Community Cancer Research United
People needed: 24
Starts: 2013-10-18
Expected to finish: 2019-10-30
Last updated by the study team: 2020-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologic or cytologic proof of surgically unresectable stage IV malignant melanoma - including that of uveal and mucosal origin
Note: biopsy can be of locoregional disease in setting of clinically evident stage IV disease; a biopsy of the primary tumor alone does not fulfill this requirement
No more than 2 prior courses of systemic therapy for metastatic melanoma
For patients with metastatic melanoma not of uveal origin, v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation determination using a Clinical Laboratory Improvement Amendments (CLIA)-approved testing method on metastatic tumor tissue
NOTE: patients with metastatic melanoma of uveal origin do not need to have formal BRAF testing due to low probability of a BRAF V600 mutation in their metastatic tumor
Measurable disease; note: disease that is measurable by physical examination only is not eligible
Life expectancy of >= 4 months
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Absolute neutrophil count >=1500/mL (obtained =< 14 days prior to registration/randomization)
Platelet count >= 100,000 x 10\^9/L (obtained =< 14 days prior to registration/randomization)
Hemoglobin >= 9 g/dL (obtained =< 14 days prior to registration/randomization) (patients may be transfused to meet this requirement)
Creatinine =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization); institutional norms are acceptable
Total bilirubin =< 1.5 mg/dL (obtained =< 14 days prior to registration/randomization) (exception: patients with documented Gilbert?s syndrome are allowed to participate despite elevated bilirubin)
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN (obtained =< 14 days prior to registration/randomization)
Alkaline phosphatase =< 2.5 x ULN (obtained =< 14 days prior to registration/randomization); if bone metastasis is present in the absence of liver metastasis then =< 5 x ULN
Urine dipstick for proteinuria < 2+ (obtained =< 14 days prior to registration/randomization) (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1 g of protein in 24 hours to be eligible)
Negative serum pregnancy test done =< 7 days prior to registration/randomization, for women of childbearing potential only
Note:
Females: adequate contraception must be used by both patient and partner while receiving study drug and for 12 weeks after the last dose of study drug
Males: adequate contraception must be used by both patient and partner while receiving study drug; men who have a partner of childbearing age should also avoid fathering a child for 6 months after the last dose of study drug
Ability to understand and the willingness to sign a written informed consent document
Mayo Rochester patients only: willingness to provide mandatory blood samples for research purposes

You may not qualify if…

Brain metastases per magnetic resonance imaging (MRI) or computed tomography (CT)
Note: patients who have had therapy for brain metastasis (i.e., surgical resection, whole brain radiation, or stereotactic radiosurgery [SRS] even if stable) are not eligible
Other investigational agents =< 4 weeks prior to registration/ randomization
Anti-cancer therapy (including immunotherapy) =< 4 weeks prior to registration/randomization; exception: adjuvant Leukine =< 14 days prior to registration/randomization
Prior treatment in the adjuvant or metastatic setting with any of the following:
Agents disrupting VEGF activity or targeting vascular endothelial growth factor receptor (VEGFR);
Ipilimumab;
Or taxane based chemotherapy regimens (including paclitaxel, docetaxel, cabazitaxel or nab-paclitaxel)
Major surgical procedure, open biopsy, or significant traumatic injury =< 4 weeks prior to registration/randomization; (port-a-cath placement does not count as a major surgical procedure and patients can be enrolled at any time after placement)
Fine needle aspirations or core biopsies =< 7 days prior to registration/ randomization
Planned/or anticipated major surgical procedure during the course of the study
Other medical conditions including but not limited to:
History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C
Active infection requiring parenteral antibiotics
Poorly controlled high blood pressure (>= 150 mmHg systolic and/or 100 mmHg diastolic) despite treatment
New York Heart Association class II-IV congestive heart failure
Serious cardiac arrhythmia requiring medication
Myocardial infarction or unstable angina =< 6 months prior to registration/randomization
Clinically significant peripheral vascular disease
Deep venous thrombosis or pulmonary embolus =< 1 year of registration/randomization
Ongoing need for full-dose oral or parenteral anticoagulation
Ongoing anti-platelet treatment other than low-dose aspirin (i.e., aspirin 81 mg by mouth daily)
Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices, etc.)
Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 6 months prior to registration/randomization

Where it is running

Saint Mary's Medical Center — San Francisco, California, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States
University of Illinois — Chicago, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
Siouxland Regional Cancer Center — Sioux City, Iowa, United States
Cancer Research Consortium of West Michigan NCORP — Grand Rapids, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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