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A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma

NCT03597282 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-09-03

No results posted yet for this study

Summary

The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment.

Conditions

Interventions

BIOLOGICAL

NEO-PV-01

Personal Cancer Vaccine

BIOLOGICAL

Nivolumab

monoclonal antibody against PD-1

OTHER

Adjuvant

immune adjuvant

BIOLOGICAL

APX005M

monoclonal agonist antibody against CD40

BIOLOGICAL

ipilimumab

monoclonal antibody against CTLA4

Sponsors & Collaborators

  • Apexigen America, Inc.

    collaborator INDUSTRY

  • BioNTech US Inc.

    lead INDUSTRY

Principal Investigators

  • Mark DeMario, MD · BioNTech US Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2020-05-05
Completion
2020-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03597282 on ClinicalTrials.gov