What side effects are associated with this type of intervention?

Common treatments for cervical cancer, particularly immunotherapies targeting PD-1 and CTLA-4, such as nivolumab and ipilimumab, can cause a range of side effects. These include immune-related adverse events like colitis, pneumonitis, hepatitis, endocrinopathies (e.g., hypothyroidism), and skin reactions (e.g., rash, pruritus). Chemotherapy, often used in combination with immunotherapy, can lead to nausea, vomiting, fatigue, neutropenia, and increased risk of infection. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of cervical cancer, particularly those targeting the PD-1 pathway. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for use in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, especially in cases with PD-L1 expression. While there are no specific FDA approvals for bispecific antibodies targeting both PD-1 and CTLA-4 in cervical cancer, the approval of pembrolizumab highlights the potential of immune checkpoint inhibitors in this setting. Other treatments for cervical cancer include chemotherapy, radiation, and targeted therapies, but the focus on immunotherapy is growing due to its promising results in enhancing the immune response against cancer cells.

What other types of research exist?

Promising alternatives to MGD019 for cervical cancer patients include pembrolizumab (an anti-PD-1 antibody) and nivolumab (another anti-PD-1 antibody), both of which have shown efficacy in various cancers, including cervical cancer. Additionally, combination therapies such as pembrolizumab plus lenvatinib (a VEGFR inhibitor) are being investigated and have shown promising results. These treatments enhance the immune response and may offer effective options for cervical cancer patients in 2024.

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Monoclonal Antibodies

MGD019 for Cervical Cancer

Phase 2

Recruiting

Led By Amir Jazeri, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the study completion an average of 1 year.

Awards & highlights

Study Summary

This trial will test if MGD019 can help control cervical cancer in patients who have not yet received treatment.

Who is the study for?

This trial is for adults over 18 with confirmed recurrent, metastatic, or persistent cervical cancer who haven't had treatment yet. They must be able to follow the study protocol and have adequate organ function. Women should be post-menopausal or not pregnant and everyone must meet certain blood count criteria. Those vaccinated against COVID-19 need to wait at least 14 days before starting the trial.Check my eligibility

What is being tested?

MGD019 is being tested to see if it can control advanced cervical cancer in patients who are receiving their first treatment. The study will monitor how well this drug works and its safety in participants meeting specific health criteria.See study design

What are the potential side effects?

While specific side effects of MGD019 aren't listed here, similar drugs often cause immune-related reactions, fatigue, nausea, skin issues, and may affect liver enzymes. Participants will be monitored closely for any adverse effects during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the study completion an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the study completion an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study completion an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To establish overall survival (OS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: MGD019Experimental Treatment1 Intervention

Participants will receive MGD019 by vein over about 30 minutes on Day 1 of each cycle

Do I qualify?Apply below to find out

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

The most common treatments for cervical cancer include surgery, radiation therapy, chemotherapy, and immunotherapy. Immunotherapy, particularly immune checkpoint inhibitors like those targeting PD-1 and CTLA-4, works by enhancing the body's immune response against cancer cells. These inhibitors block proteins that prevent T-cells from attacking cancer cells, thereby boosting the immune system's ability to fight the cancer. This is particularly important for cervical cancer patients as it offers a targeted approach that can be effective even in advanced stages of the disease. Other treatments like chemotherapy and radiation work by directly killing cancer cells or inhibiting their growth, but they can also affect healthy cells, leading to more side effects. The trial MGD019, which involves a bispecific antibody targeting both PD-1 and CTLA-4, aims to further enhance the immune response, potentially offering a more effective treatment option for patients.

Optimizing immunotherapy for gynecologic cancers.Immunotherapy in endometrial cancer: new scenarios on the horizon.Immune Checkpoint Inhibitors in the Treatment of Gynecologic Malignancies.

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Who is running the clinical trial?

MacroGenicsIndustry Sponsor

48 Previous Clinical Trials

5,339 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,987 Previous Clinical Trials

1,791,695 Total Patients Enrolled

Amir Jazeri, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

MGD019 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05475171 — Phase 2

Cervical Cancer Research Study Groups: MGD019

Cervical Cancer Clinical Trial 2023: MGD019 Highlights & Side Effects. Trial Name: NCT05475171 — Phase 2

MGD019 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05475171 — Phase 2

~23 spots leftby Jun 2026

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