Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Parker Institute for Cancer Immunotherapy
Study ID
NCT03214250
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

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

Interventions

  • APX005M — DRUG
    Administer intravenously once every 28-day Cycle
  • Nivolumab — DRUG
    Administer intravenously twice every 28-day cycle
  • Nab-Paclitaxel — DRUG
    Administer intravenously on 3 times every 28-day cycle
  • Gemcitabine — DRUG
    Administer intravenously 3 times every 28-day cycle

Study Details

The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.

Key Dates

Start date
Jul 21, 2017
Status verified
Dec 2022
Primary completion
Feb 11, 2021
Completion
Feb 25, 2022

Study Design

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

Arms

  • Experimental: Gem/NP/nivolumab
    Gemcitabine+Nab-Paclitaxel+nivolumab
  • Experimental: Gem/NP/APX005M
    Gemcitabine+Nab-Paclitaxel+APX005M
  • Experimental: Gem/NP/nivolumab/APX005M
    Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M

Primary Outcome Measure

Phase 1b Primary Safety Outcome [ Time Frame: Initiation of study drug (or informed consent for SAEs) through 100 days after the last dose of study drug or initiation of a new systemic anti-cancer therapy with a maximum exposure of 34.3 months. ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-
M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAStanford University· Stanford, CADana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Pennsylvania, Abramson Cancer Center· Philadelphia, PA

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