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

NCT03214250 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-12-23

Study results available
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Summary

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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

APX005M

Administer intravenously once every 28-day Cycle

DRUG

Nivolumab

Administer intravenously twice every 28-day cycle

DRUG

Nab-Paclitaxel

Administer intravenously on 3 times every 28-day cycle

DRUG

Gemcitabine

Administer intravenously 3 times every 28-day cycle

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Apexigen America, Inc.

    collaborator INDUSTRY

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Parker Institute for Cancer Immunotherapy

    lead OTHER

Principal Investigators

  • Parker Institute for Cancer Immunotherapy · Parker Institute for Cancer Immunotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2021-02-11
Completion
2022-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03214250 on ClinicalTrials.gov