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A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer | Clinical Trials | Clareo Health

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

An Open-Label, Phase 1B Study of NEO-PV-01 With Pembrolizumab Plus Chemotherapy in Patients With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

NCT03380871•BioNTech US Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This clinical trial will enroll patients with advanced or metastatic nonsquamous non-small cell lung carcinoma not having received treatment for metastatic disease. The five agents being used in this study are: * A new, investigational, personalized cancer vaccine called "NEO-PV-01" * Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system * A cancer drug called pembrolizumab (KEYTRUDA®) * A chemotherapy called pemetrexed (ALIMPTA®) * A chemotherapy called carboplatin Both NEO-PV-01 and pembrolizumab are considered immunotherapies and work using the immune system to fight cancer. NEO-PV-01 is a custom made vaccine for you that is based on the specific targets on your cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01, more effective. Pembrolizumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack your cancer. Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, including the type of cancer that you have. Recently, the FDA also approved the combination of Pembrolizumab with chemotherapy for the treatment of your type of lung cancer. This combination works better than each of the drugs on their own. The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and 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 immune response compared with pembrolizumab and chemotherapy treatment alone. The side effects of NEO-PV-01, pembrolizumab, and chemotherapy will be monitored and additional research tests will be done to assess your immune response to your cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to give written informed consent.
•Have histologically confirmed unresectable or metastatic nonsquamous NSCLC and having received no prior systemic therapy for metastatic disease.
•Have at least 1 site of disease measurable by RECIST v1.1 that has not been treated with local therapy within 6 months of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
•At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue for sequence and immunological analysis. This site may be a target lesion as long as it will not be made unmeasurable by the biopsy procedure.
•Have ECOG PS of 0 or 1 with an anticipated life expectancy of \> 6 months.
•Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (eg, alopecia or vitiligo).
•Screening laboratory values must meet the following criteria and should be obtained within 30 days (or 45 days if a biopsy is repeated) prior to study treatment:
•1. White blood cell (WBC) count ≥ 3 × 10e3/µL
•2. Absolute neutrophil count (ANC) ≥ 1.5 × 10e3/µL
•3. Platelet count ≥ 100 × 10e3/µL
+12 more criteria

Exclusion Criteria

•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of treatment.
•Received any systemic therapy for cancer treatment including immunotherapeutic agents such as anti-PD1 or anti-PD-L1 antibody therapy.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 30 days prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•1. Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
•2. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
•Patients may not receive or have received any radiation therapy at the biopsy sites.
•Received radiation therapy to the lung \> 30 Gy within 6 months of first dose of study treatment.
•Received prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study treatment.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or CT scan) for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
+18 more criteria

Locations (5)

University of California - Los Angeles

Santa Monica, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University in St. Louis

St Louis, Missouri, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Key Dates

Start Date

May 4, 2018

Primary Completion Date

October 31, 2019

Completion Date

February 5, 2021

Last Updated

February 26, 2021

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell LungLung CancerNonsquamous Nonsmall Cell Neoplasm of Lung

Interventions

NEO-PV-01

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Adjuvant

OTHER

Carboplatin

DRUG

Pemetrexed

DRUG

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Non-Small-Cell Lung Cancer

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RECRUITING

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Magnetic Resonance Imaging of the Lung: Oncological Applications

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)