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

NCT02158520 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-21

Study results available
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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.

Conditions

  • Metastatic Melanoma
  • Mucosal Melanoma
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IV Uveal Melanoma AJCC v7
  • Unresectable Melanoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nab-paclitaxel

Given IV

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    lead OTHER

Principal Investigators

  • Svetomir N Markovic · Academic and Community Cancer Research United

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-18
Primary Completion
2017-05-24
Completion
2019-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158520 on ClinicalTrials.gov