Study on Immunotherapy Induction for Advanced Cervical Cancer (TRACTION)
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05475171
This clinical trial is exploring whether the drug MGD019 can help control cervical cancer in patients who have not yet received treatment. The study aims to understand the effectiveness and safety of this immunotherapy approach.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the drug MGD019 can help manage cervical cancer in patients who have not received any prior chemotherapy. Researchers are looking at how well the cancer is controlled, how long patients live without the disease getting worse, and how safe the treatment is. They are also studying changes in the cancer cells and immune system before and during treatment to better understand how the drug works.
Description
This study is focused on patients with advanced cervical cancer that has spread, returned, or is persistent. The main goal is to see if the drug MGD019 can help control the disease in patients who have not had chemotherapy before. Researchers will also look at how long patients live without the cancer getting worse, how long the treatment works, and any side effects. They will also study changes in the cancer and immune cells to understand how the treatment affects them.
Participants will need to meet certain health criteria and agree to follow the study procedures, including regular visits and tests. The study will also explore the use of cell-free DNA to evaluate how well the treatment is working.
Eligibility Criteria
Inclusion Criteria
- Must be able to provide signed consent to participate.
- Must be 18 years or older.
- Must be willing and able to follow the study procedures, including treatment and scheduled visits.
- Must have cervical cancer that has returned, spread, or is persistent, confirmed by a biopsy or CT scan.
- Must have one of the following types of cervical cancer: squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- Cancer must not be treatable with surgery or radiation alone.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have measurable disease according to standard criteria.
- Must have adequate organ and bone marrow function, including:
- Hemoglobin level of at least 8.0 g/dL.
- Neutrophil count greater than 1000/mm3.
- Platelet count of at least 75,000/mm3.
- Liver and kidney function within specified limits.
- Women must be post-menopausal or have a negative pregnancy test if of childbearing potential.
- Must have received the last COVID-19 vaccine dose at least 14 days before starting the study treatment.
- Must have recovered from any major surgery or previous treatments before starting the study treatment.
Exclusion Criteria
- Cannot have had prior chemotherapy unless it was given with radiation therapy.
- Cannot be pregnant, breastfeeding, or planning to become pregnant during the study and for 120 days after the last treatment dose.
- Cannot have received previous immune checkpoint inhibitor therapy or cytokines.
- Cannot have active infections like hepatitis B or C, or uncontrolled HIV, unless stable and controlled.
- Cannot have a history of lung disease requiring steroids, oxygen, or hospitalization.
- Cannot have significant heart disease or recent heart events.
- Cannot have a history of immune system deficiencies or be on high-dose steroids or immunosuppressive therapy.
- Cannot have active cancer spread to the brain or spinal cord unless stable and not requiring steroids.
- Cannot have had another cancer unless treated and cancer-free for 2 years, with some exceptions.
- Cannot have active autoimmune diseases requiring treatment in the past 2 years, except for replacement therapies.
- Cannot have other illnesses that might affect the safety of the treatment.
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