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Virus Therapy

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

Phase 1 & 2
Recruiting
Led By Christina M Annunziata, MD,PhD
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)
Must not have
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to start of study therapy
No archival tissue available and a lesion(s) that cannot be safely biopsied via percutaneous route, or is unwilling to undergo biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I don't have stored tissue samples and cannot or do not want to have a biopsy.
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I have not had major surgery in the last 14 days.
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I do not have any uncontrolled illnesses like infections, diabetes, heart issues, or abnormal heart rhythms.
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I am HIV-positive and not on antiretroviral therapy.
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I had a severe reaction to previous immune therapy that needed steroids or other drugs and had to stop the treatment.

Timeline

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cervical cancer treatments like the investigational agent NEO-201 and the PD-1 inhibitor pembrolizumab work by enhancing the body's immune response against cancer cells. NEO-201 targets specific tumor-associated antigens, helping the immune system recognize and attack cancer cells more effectively. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway, which cancer cells often exploit to evade immune detection. By inhibiting this pathway, pembrolizumab reactivates T-cells, allowing them to identify and destroy cancer cells. These mechanisms are crucial for cervical cancer patients as they offer a targeted approach to treatment, potentially leading to better outcomes and fewer side effects compared to traditional therapies.
Human Papillomavirus Induced Cervical and Oropharyngeal Cancers: From Mechanisms to Potential Immuno-therapeutic Strategies.Optimizing immunotherapy for gynecologic cancers.The forgotten woman's cancer: vulvar squamous cell carcinoma (VSCC) and a targeted approach to therapy.

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Who is running the clinical trial?

Precision Biologics, IncLead Sponsor
3 Previous Clinical Trials
275 Total Patients Enrolled
Christina M Annunziata, MD,PhDPrincipal InvestigatorNational Cancer Institute - Women's Malignancy Branch
Kevin Conlon, MDPrincipal InvestigatorNational Cancer Institute - Women's Malignancy Branch

Media Library

Cervical Cancer Research Study Groups: NEO-201 in combination with pembrolizumab
~21 spots leftby Oct 2025