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Clinical Trial DRUG ABI-007-ST-001

Title
A Phase 1, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination with Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, nab-Paclitaxel / Carboplatin In Stage IIIb/IV Non-Small Cell Lung Cancer or nab-Paclitaxel in Recurrent Metastatic Breast Cancer
Principal Investigator
Aparna Kalyan
Details
  • Status: SUSPENDED
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG ABI-007-ST-001
Purpose
The purpose of this study is to assess the safety of nivolumab in combination with Abraxane (nab-paclitaxel) based chemotherapy treatments.
Overview
nab-Paclitaxel is a different formulation of paclitaxel that does not require the co-administration of steroids, drugs which could potentially reduce the body’s immune response. Nivolumab is an investigational agent designed to allow the body’s own immune system to destroy tumors. In this study, the use of nivolumab alone or in combination with nab-paclitaxel based chemotherapy is investigational (it has not been approved by the US Food and Drug Administration [FDA]).
Eligibility
Some of the eligibility criteria include:
  • Participants must have either locally advanced pancreatic cancer, advanced staged non-small cell lung cancer, or metastatic breast cancer.
  • Participants must be 18 or older.
  • Prior treatments may be allowed on this study, but this varies by disease. Please talk to the study doctor about all prior treatments.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
This study includes 3 tumor types (pancreatic, non-small cell lung cancer and breast cancer) with 2 different treatment arms per tumor type. For participants with pancreatic cancer, the treatment arms are Arm A - nab-paclitaxel plus nivolumab or Arm B - nab-paclitaxel in combination with gemcitabine plus nivolumab. For participants with non-small cell lung cancer, the treatment arms are Arm C - nab-paclitaxel administered in combination with carboplatin plus nivolumab starting in cycle 1 or Arm D - nab-paclitaxel administered in combination with carboplatin plus nivolumab starting in cycle 3. For subjects with metastatic breast cancer, the treatment arms are Arm E - nab-paclitaxel administered weekly, in a 3 out of 4 week schedule and nivolumab starting in cycle 3 or Arm F - nab-paclitaxel administered once every 3 weeks and nivolumab starting in cycle 3.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 19-Oct-17 07:34 AM

 

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