A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer

NCT03380871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-02-26

No results posted yet for this study

Summary

The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Nonsquamous Nonsmall Cell Neoplasm of Lung

Interventions

BIOLOGICAL

NEO-PV-01

Personal Cancer Vaccine

BIOLOGICAL

Pembrolizumab

monoclonal antibody against PDL1

OTHER

Adjuvant

immune adjuvant

DRUG

Carboplatin

chemotherapy

DRUG

Pemetrexed

chemotherapy

Sponsors & Collaborators

Principal Investigators

  • Mark DeMario, MD · BioNTech US Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2019-10-31
Completion
2021-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03380871 on ClinicalTrials.gov