MGD019 for Cervical Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAmir Jazeri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immune checkpoint inhibitors, Cytokines

Disqualifiers: Pregnancy, Active infection, Cardiovascular disease, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or systemic steroids, you may need to stop them before starting the trial.

Research Team

Amir Jazeri, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow the study's treatment plan and attend all visits.

I received my last COVID-19 vaccine dose more than 14 days ago.

My blood clotting tests are within normal limits, unless I'm on blood thinners.

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Exclusion Criteria

I have not had chemotherapy unless it was with radiation.

I have received treatments like immunotherapy before.

I have an autoimmune disease treated with medication in the last 2 years.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Immunotherapy

Participants receive MGD019 to control cervical cancer

6-12 weeks

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

MGD019 (Monoclonal Antibodies)

Trial OverviewMGD019 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.

Participant Groups

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