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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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing MGD019, an immunotherapy, to see if it can help the immune system fight advanced cervical cancer in patients who haven't had chemotherapy.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: LorigerlimabExperimental Treatment1 Intervention
Participants will receive Lorigerlimab by vein over about 30 minutes on Day 1 of each cycle

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.

Find a Location

Who is running the clinical trial?

MacroGenicsIndustry Sponsor
48 Previous Clinical Trials
5,092 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,184 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: Lorigerlimab
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
~18 spots leftby Jun 2026