MGD019 for Cervical Cancer

Overseen By Amir Jazeri, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immune checkpoint inhibitors, Cytokines

Disqualifiers: Pregnancy, Active infection, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial tests a new drug, MGD019, to determine its effectiveness in controlling cervical cancer in patients without prior treatment. Participants receive Lorigerlimab (also known as MGD019, the experimental treatment) through an IV on the first day of each cycle. This trial suits those with confirmed, recurrent, metastatic, or persistent cervical cancer that cannot be treated with surgery or radiation. Individuals with specific types of cervical cancer, such as squamous cell carcinoma, adenosquamous, or adenocarcinoma, may qualify. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that MGD019 is likely to be safe for humans?

Research has shown that MGD019, also known as Lorigerlimab, is generally safe for patients with various types of cancer. Early results suggest that most patients tolerate the treatment well, with side effects typically being mild to moderate. Serious side effects occurred less frequently and were manageable.

Data supports the treatment's safety by demonstrating its ability to help immune cells fight cancer. This effect has been observed in various cancers, even in patients who have undergone many previous treatments. Although the exact phase of this trial cannot be discussed, the current testing of MGD019 indicates that earlier research has confirmed its safety.

For those considering joining the trial, these findings suggest that MGD019 has been safe for similar patients. However, discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cervical cancer, which typically involve chemotherapy, radiation, or surgery, Lorigerlimab is a promising new approach that involves an experimental antibody treatment. This drug works by targeting specific proteins on cancer cells, potentially enhancing the immune system's ability to recognize and destroy these cells. Researchers are excited about Lorigerlimab because it offers a novel mechanism of action that could lead to improved outcomes, especially for patients who have not responded well to traditional therapies. Its intravenous administration also allows for direct delivery into the bloodstream, which might maximize its effectiveness against the cancer.

What evidence suggests that MGD019 might be an effective treatment for cervical cancer?

Research shows that lorigerlimab, also known as MGD019, might help treat cervical cancer. In earlier studies, some patients experienced stable disease, meaning their cancer did not worsen. The treatment reduced tumor size in 13.3% of patients. Participants in this trial will receive lorigerlimab, which targets PD1/PDL1, proteins that help cancer cells evade the immune system. This method has shown promise, with early results suggesting a strong response in similar treatments. These findings suggest lorigerlimab could be a good option for managing cervical cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Amir Jazeri, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MGD019

Trial Overview 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.

How Is the Trial Designed?

Group I: Lorigerlimab Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

MacroGenics

Industry Sponsor

Trials

51

Recruited

5,400+

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02422

A Study of Lorigerlimab in Participants With Advanced ... The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC. Participants will receive lorigerlimab by intravenous (IV) ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05475171?draw=2&rank=1

NCT05475171 | Triage of Advanced Cervical Cancer ... Primary Objectives: To estimate disease control rate (DCR) in patients with metastatic, recurrent, or persistent cervical cancer who have not received prior ...

3. onclive.com onclive.com/view/dart-molecule-mgd019-displays-monotherapy-efficacy-in-heavily-pretreated-solid-tumors

DART Molecule MGD019 Displays Monotherapy Efficacy in ... Ten patients overall had stable disease as their best response. The objective response rate in the total cohort was 13.3% with a disease control ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=69ed2104-2259-4f5d-8acb-9dbb97b9586c

lorigerlimab (MGD019) / MacroGenics - Oncology P2 data • Trial status • Cervical Cancer • Endometrial Cancer • Fallopian Tube Cancer ... - "Updated TAMARACK safety and efficacy data, including the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12106400/

The promise of PD1/PDL1 targeted immunotherapy in locally ... The interim analysis demonstrated promising results on eight patients that completed the treatment, showing a complete response rate of 87.5% on PET at 3 months ...

6. macrogenics.com macrogenics.com/wp-content/uploads/2023/03/CICON-2019-MGD019.pdf

MGD019, a PD-1 x CTLA-4 Tetravalent Bispecific DART® ... These data indicate support clinical testing of MGD019 in cancer patients. Introduction. T Cells Co-expressing PD-1 and CTLA-4 Are Prevalent. Among TILs ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06730347

NCT06730347 | A Study of Lorigerlimab in Participants ... The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC. Participants will receive lorigerlimab by intravenous (IV) ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/351936

Triage of Advanced Cervical Cancer Through ... Brief summary. To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.