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
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
-
monoclonal antibody against PDL1
- OTHER
-
Adjuvant
immune adjuvant
- DRUG
-
chemotherapy
- DRUG
-
Pemetrexed
chemotherapy
Sponsors & Collaborators
- collaborator INDUSTRY
-
BioNTech US Inc.
lead INDUSTRY
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
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