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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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.
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
5,092 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,606 Total Patients Enrolled
Amir Jazeri, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy unless it was with radiation.I am willing and able to follow the study's treatment plan and attend all visits.I have received treatments like immunotherapy before.I received my last COVID-19 vaccine dose more than 14 days ago.I have an autoimmune disease treated with medication in the last 2 years.My blood clotting tests are within normal limits, unless I'm on blood thinners.I am 18 years old or older.I have a lung condition that has needed steroids, oxygen, or hospital care.My cancer has spread to my brain or its coverings.I am fully active or can carry out light work.I do not have any ongoing infections, hepatitis B or C, or uncontrolled HIV.I have had serious heart problems or a QTcF over 470 in the last year.I am post-menopausal or not pregnant if pre-menopausal.I have a weak immune system or am on long-term steroids or other drugs that weaken my immune system.My doctor thinks other health issues I have could make immunotherapy unsafe for me.My condition cannot be cured with surgery or radiation.My organs and bone marrow are functioning well.My cervical cancer has come back or spread, confirmed by biopsy or CT scan.My cancer is either squamous cell, adenosquamous, or adenocarcinoma.I had another cancer but was treated successfully and have been cancer-free for 2 years.I have recovered from major surgery or past treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Lorigerlimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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