Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Lorigerlimab
DrugGiven by vein (IV)
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: LorigerlimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To establish overall survival (OS)
Time frame
through the study completion an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
MacroGenics
Collaborator
Source ClinicalTrials.gov