Phase 2
N=24
Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery
Metastatic Melanoma · Mucosal Melanoma · Stage IV Cutaneous Melanoma AJCC v6 and v7 · Stage IV Uveal Melanoma AJCC v7 · Unresectable Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02158520 ↗Enrolled (actual)
24
Serious AEs
26.3%
Results posted
Jan 2020
Primary outcome: Primary: Progression-free Survival (PFS) — 139; 94 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Biological); Ipilimumab (Biological); Laboratory Biomarker Analysis (Other); Nab-paclitaxel (Drug); Pharmacological Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Academic and Community Cancer Research United
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
139; 94 | — |
| SECONDARY Overall Survival (OS) |
18.4; 27.0 | — |
| SECONDARY Number of Patients With Tumor Response |
2; 0; 1; 1 | — |
| SECONDARY The Number of Patients Who Experienced Toxicity |
9; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 = = 100,000 x 10^9/L (obtained = = 9 g/dL (obtained = = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate = = 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 = = grade 2 (from any cause)
- History of other malignancy = 25% of their functional bone marrow irradiated are not eligible for this trial
- Active or recent history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registration/randomization
- Known hypersensitivity to any of the components of ipilimumab, bevacizumab, or nab-paclitaxel
- History of inflammatory bowel disease (e.g., Crohn?s, ulcerative colitis) - note patients with irritable bowel syndrome are eligible
- Diagnosis of autoimmune disease (i.e., rheumatoid arthritis, scleroderma, systemic lupus erythematosus [SLE], autoimmune vasculitis, Guillain-Barre syndrome, etc.), regardless if patient is currently receiving treatment at time of registration/randomization
- Systemic corticosteroids use =< 2 weeks, regardless of indication; note: patients who are on inhaled corticosteroids are eligible
Data sourced from ClinicalTrials.gov (NCT02158520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.