Clinical trial for Metastatic Cancer
Official title Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)
ClinicalTrials.gov ID: NCT05475171
What this study is testing
What is Lorigerlimab?
Lorigerlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic cancer.
Also referred to as MGD019.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- will be assessed within 28 days of starting study treatment:
- 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...
- Biopsy or CT scan confirmed recurrent, metastatic, or persistent cervical cancer
You likely can't join if
- Exclusion criteria will be assessed within 28 days of starting study treatment:
- 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...
- 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...
- History of chronic obstructive pulmonary disease or other intrinsic lung disease requiring systemic steroid therapy, oxygen, or hospitalization
See the full eligibility criteria
- will be assessed within 28 days of starting study treatment:
- 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
- Measurable disease by RECIST v1.1
- Adequate normal organ and marrow function as defined below.
- Hemoglobin ≥8.0 g/dL.
- Absolute neutrophil count (ANC) \> 1000/mm3 .
- Platelet count ≥100 x 109 /L (\>75,000/mm3 ).
- Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic...
- AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.
- International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic...
- Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance...
- Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical...
- Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiationinduced menopause with last menses...
- If vaccinated against COVID-19, the last vaccine dose must be 14 days or greater from the first investigational product administration.
- If a participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Participants must have recovered from all AEs...
- Exclusion criteria will be assessed within 28 days of starting study treatment:
- 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...
- 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...
- 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...
- 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...
- Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful...
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Other illnesses/conditions that in the investigator's opinion would adversely affect the safety of checkpoint inhibitor therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.