Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION) (NCT05475171) | Clinical Trial Compass
SuspendedPhase 2
Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)
Stopped: PI request
United States47 participantsStarted 2022-12-13
Plain-language summary
To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to provide signed informed consent
. Age ≥ 18 years at time of study entry
. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
. Biopsy or CT scan confirmed recurrent, metastatic, or persistent cervical cancer
. One of the following histologic subtypes: squamous cell carcinoma, adenosquamous, or adenocarcinoma
. Not amenable to curative treatment (e.g. surgery and/or radiation)
. Eastern Cooperative Oncology Group performance status 0 - 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To establish overall survival (OS)
Timeframe: through the study completion an average of 1 year.
. Prior systemic chemotherapy except when used with concurrent radiation therapy
. Is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
. Previous immune checkpoint inhibitor therapy or cytokines
. Ongoing or active systemic infection, active hepatitis B or C infection, or known uncontrolled HIV, that might affect host immunity. Patients with stable, controlled HIV (defined as CD4+ T-cell counts ≥ 350 cells/uL, on established antiretroviral therapy for at least 4 weeks, and have an HIV viral load less than 400 copies/mL prior to enrollment) are eligible for trial inclusion.
. History of chronic obstructive pulmonary disease or other intrinsic lung disease requiring systemic steroid therapy, oxygen, or hospitalization
. History of clinically significant cardiovascular disease or QTcF \> 470 within 12 months from first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular event, or cardiac arrhythmia associated with hemodynamic instability. Note: medically controlled arrhythmia would be permitted.
. History of immunodeficiency or receiving chronic systemic steroid or other immunosuppressive therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Steroid premedications for radiologic contrast allergy are permitted.
. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.