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Virus Therapy

NEO-201 + Pembrolizumab for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Led By Azam Ghafoor, MD

Research Sponsored by Precision Biologics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is not a candidate for potentially curative surgery or radiation

At least 4 weeks must have elapsed since any chemotherapeutic agents at the time of enrollment (or 6 weeks for regimens containing BCNU or mitomycin C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, NEO-201, to see if it is safe and effective. So far, the results look promising, with the Maximum Tolerated Dose being 1.5mg/kg. The Expansion Phase of the study is now enrolling patients with non-small cell lung cancer, head and neck squamous cell carcinoma, and cervical and uterine cancers.

Who is the study for?

Adults with certain advanced cancers (lung, head and neck, cervical, uterine) that worsened after standard treatment can join. They need a biopsy sample available or agree to a new biopsy. Participants must be at least 18 years old, not pregnant or breastfeeding, use birth control if applicable, have no severe illnesses or brain metastases under control without seizures.Check my eligibility

What is being tested?

The trial is testing NEO-201 combined with pembrolizumab in patients whose cancer has progressed despite previous treatments. The study will administer NEO-201 every two weeks and pembrolizumab every six weeks to see how well they work together against the cancer.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation of organs, infusion-related reactions like fever or chills during drug administration, fatigue, digestive issues like nausea or diarrhea, blood disorders which could affect cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Surgery or radiation cannot cure my condition.

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It has been over 4 weeks since my last chemotherapy session.

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I am 18 years old or older.

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My cancer is advanced, cannot be surgically removed, and has been confirmed by a pathology lab.

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My cancer has worsened despite treatment.

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My tumor tests positive for NEO-201 antigen.

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I can provide tissue samples or undergo a biopsy for my tumor.

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It's been over 2 weeks since my last TKI treatment or any related side effects have gone.

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I haven't taken any systemic corticosteroids in the last 2 weeks.

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It has been over 42 days since my last immunotherapy treatment.

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I am mostly self-sufficient and can do daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine Objective Response Rate (either Complete Response or Partial Response) as determined by RECIST v1.1 guidelines

Determine Progression Free Survival as determined by RECIST v1.1 guidelines

Determine the safety of the combination of NEO-201 with pembrolizumab the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary outcome measures

Characterize Peak Plasma Concentration (Cmax) of the pharmacokinetics (PK) of NEO-201 in combination with pembrolizumab.

Characterize the Minimum Plasma Concentration (Cmin) of the pharmacokinetics (PK) of NEO-201 in combination with pembrolizumab.

Characterize the area under the concentration-time curve (AUC) of the pharmacokinetics (PK) of NEO-201 combination therapy with pembrolizumab.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: NEO-201 in combination with pembrolizumabExperimental Treatment1 Intervention

Subjects will receive 3 doses NEO-201 in combination with one dose of pembrolizumab in a 42 day cycle. This course will be repeated in the absence of disease progression or unacceptable toxicity.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Precision Biologics, IncLead Sponsor

3 Previous Clinical Trials

275 Total Patients Enrolled

Azam Ghafoor, MDPrincipal InvestigatorNational Cancer Institute - Thoracic and GI Malignancy Branch

Charalampos Floudas, MDPrincipal InvestigatorNational Cancer Institute - Head and Neck/GUMB

Media Library

Cervical Cancer Research Study Groups: NEO-201 in combination with pembrolizumab

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior experiments have been conducted with the combination of NEO-201 and pembrolizumab?

"The current tally of active studies for NEO-201 in combination with pembrolizumab stands at 961, with 122 trials in the latter stages. Houston, Texas is home to the largest share of these clinical trials; however, there are 35731 sites conducting related research across all regions."

Answered by AI

Is there any availability for subjects to join this trial?

"Searching for participants, this clinical trial was initially posted on January 18th 2019 and last updated April 1st 2022 per the information provided by clinicaltrials.gov."

Answered by AI

In what cases is the pairing of NEO-201 and pembrolizumab generally prescribed?

"NEO-201 and pembrolizumab are usually prescribed as a combination therapy to treat malignant neoplasms, however they can also be effective at managing unresectable melanoma, microsatellite instability high diseases that have progressed after chemotherapy."

Answered by AI

How many volunteers are presently participating in this investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, this experimental trial which was initially posted in January 18th 2019 is actively searching for participants. The study requires 121 individuals at a single location."

Answered by AI

What end-goals is this experiment attempting to reach?

"This clinical trial has a primary objective of evaluating the safety of NEO-201 in combination with pembrolizumab via revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 over 1.5 years. Secondary objectives include measuring area under concentration-time curve (AUC), minimum plasma concentration (Cmin), and peak plasma concentration (Cmax). Samples will be collected at various intervals to monitor drug exposure, trough concentrations, and peak concentrations respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of NEO-201 in Solid Tumors Expansion Cohorts

2019. "Study of NEO-201 in Solid Tumors Expansion Cohorts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03476681.

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