What side effects are associated with this type of intervention?

The most common treatments for cervical cancer, particularly those involving investigational agents like NEO-201 and PD-1 inhibitors such as pembrolizumab, can have a range of side effects. For NEO-201, side effects may include fatigue, muscle cramps, and rash. Pembrolizumab, a PD-1 inhibitor, is associated with immune-related adverse effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Both treatments can also cause general side effects like infusion-related reactions and fatigue. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of cervical cancer, particularly for patients with recurrent or metastatic disease whose tumors express PD-L1. This approval is based on clinical trials demonstrating its efficacy in improving overall survival and response rates. Other related drugs include nivolumab, another PD-1 inhibitor, which has shown promise in various cancers but is not specifically approved for cervical cancer. The investigational agent NEO-201, currently being studied in combination with pembrolizumab, represents a novel approach in ongoing clinical trials aimed at enhancing the immune response against cervical cancer.

What other types of research exist?

Promising novel alternatives for cervical cancer patients include the use of bevacizumab in combination with either platinum-based or nonplatinum-based chemotherapy doublets, as highlighted in pivotal phase 3 clinical trials. This regimen aims to provide effective treatment with potentially less toxicity.

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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

No Placebo-Only Group

Summary

This trial is testing a new drug called NEO-201 with an existing drug, pembrolizumab, in patients with certain types of cancer that haven't responded to initial treatments. NEO-201 helps the immune system target cancer cells, while pembrolizumab boosts the immune response against cancer. Pembrolizumab has demonstrated activity in various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 17Eligibility criteria met

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.