Safety Study of Nivolumab 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

Part of paid clinical trials in Sacramento, California.

Sponsor
Celgene
Study ID
NCT02309177
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nab-Paclitaxel — DRUG
  • Nivolumab — DRUG
  • Gemcitabine — DRUG
  • Carboplatin — DRUG

Study Details

The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).

Key Dates

Start date
Jan 12, 2015
Status verified
May 2019
Primary completion
Sep 12, 2018
Completion
Sep 12, 2018

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: nab-Paclitaxel and Nivolumab in Pancreatic Cancer
    nab-paclitaxel 125 mg/m2 on Days 1, 8 and 15, and nivolumab on Days 1 and 15 of each 28 day cycle.
  • Experimental: nab-Paclitaxel, Gemcitabine and Nivolumab in Pancreatic Cancer
    nab-paclitaxel 125 mg/m2 on Days 1, 8 and 15, gemcitabine 1000 mg/m2 on Days 1, 8 and 15, and nivolumab on Days 1 and 15 of each 28-day cycle.
  • Experimental: nab-Paclitaxel, carboplatin and nivolumab Cycle 1 in NSCLC
    nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 and carboplatin AUC 6 on Day 1 (Cycles 1 to 4 only) of each 21 day cycle; nivolumab on Day 15 of each 21 day cycle starting in Cycle 1.
  • Experimental: nab-Paclitaxel, carboplatin and nivolumab Cycle 3 in NSCLC
    nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 and carboplatin AUC 6 on Day 1 (Cycles 1 to 4 only) of each 21 day cycle; nivolumab on Day 15 of each 21 day cycle starting in Cycle 3.
  • Experimental: nab-Paclitaxel 100 mg/m2 and Nivolumab in MBC
    nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 28 day cycle, plus nivolumab on Days 1 and 15 starting in Cycle 3.
  • Experimental: nab-Paclitaxel 260 mg/m2 and Nivolumab in MBC
    nab-paclitaxel 260 mg/m2 on Days 1 of each 21 day cycle, plus nivolumab on Days 15 starting in Cycle 3.

Primary Outcome Measure

Evaluate Dose Limiting Toxicity (DLT) of each combination regimen [ Time Frame: 24 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
UC Davis Cancer CenterSacramentoCalifornia95817-
University of California Los AngelesSanta MonicaCalifornia90404-
Yale Cancer CenterNew HavenConnecticut06510-
H. Lee Moffitt Cancer Center and Research Institute University of South FloridaTampaFlorida33612-
Northwestern University-NMDTIChicagoIllinois60611-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber / Harvard Cancer InstituteBostonMassachusetts02114-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Regional Care Cancer Centers NJMorristownNew Jersey79062-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Oncology Hematology Care, Inc.CincinnatiOhio45242-
Ohio State Medical CenterColumbusOhio43210-
University of PennslyvaniaPhiladelphiaPennsylvania19104-
Seattle Cancer Center AllianceSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Sacramento, CA

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By specialty
OncologyBreast oncologyWomen's health
By research site
UC Davis Cancer Center· Sacramento, CAUniversity of California Los Angeles· Santa Monica, CAYale Cancer Center· New Haven, CTH. Lee Moffitt Cancer Center and Research Institute University of South Florida· Tampa, FLNorthwestern University-NMDTI· Chicago, ILDana Farber Cancer Institute· Boston, MA

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