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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
Age ≥ 18 years at time of study entry
Eastern Cooperative Oncology Group performance status 0 - 1
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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I am post-menopausal or not pregnant if pre-menopausal.
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My condition cannot be cured with surgery or radiation.
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My cervical cancer has come back or spread, confirmed by biopsy or CT scan.
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My blood clotting tests are within normal limits, unless I'm on blood thinners.
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My cancer is either squamous cell, adenosquamous, or adenocarcinoma.
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.
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
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Who is running the clinical trial?
MacroGenicsIndustry Sponsor
48 Previous Clinical Trials
5,054 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,324 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: MGD019
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How reliable is MGD019 in terms of safety for humans?
"As it is a Phase 2 trial, with some evidence of safety but no proof yet that the medication works effectively, MGD019 was assigned a score of two on our team's scale."
Answered by AI
Is this trial currently welcoming participants?
"Data on clinicaltrials.gov indicates that recruiting for this medical trial has ceased as of September 19th 2022, when it was last updated; however, 561 other trials are presently accepting patients at the present moment. The study first appeared on January 31st 2023."
Answered by AI
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