Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05475171

Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)

Led by M.D. Anderson Cancer Center · Updated on 2025-11-19

40

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

M

MacroGenics

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.

CONDITIONS

Official Title

Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide signed informed consent
  • Age 18 years or older at study entry
  • Willing and able to follow the study protocol including treatments and visits
  • Biopsy or CT scan confirmed recurrent, metastatic, or persistent cervical cancer
  • Histologic subtype of squamous cell carcinoma, adenosquamous, or adenocarcinoma
  • Not suitable for curative treatment such as surgery or radiation
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Measurable disease by RECIST v1.1 criteria
  • Adequate organ and marrow function including hemoglobin �38.0 g/dL, ANC >1000/mm3, platelet count �35100 x 10^9/L, serum bilirubin �341.5 x ULN (exceptions for Gilbert's syndrome), AST/ALT �342.5 x ULN or �345 x ULN if liver metastases present, INR/PT/aPTT �341.5 x ULN (with anticoagulant exceptions), and creatinine clearance >40 mL/min
  • Post-menopausal status or negative pregnancy test for pre-menopausal females with specific age-related criteria
  • COVID-19 vaccination completed at least 14 days before first treatment
  • Adequate recovery from any prior major surgery and related adverse events at or below Grade 1 (some exceptions may apply)
Not Eligible

You will not qualify if you...

  • Prior systemic chemotherapy except when given with radiation therapy
  • Pregnant, breastfeeding, or planning pregnancy during study and 120 days after last treatment
  • Previous treatment with immune checkpoint inhibitors or cytokines
  • Active systemic infection, active hepatitis B or C, or uncontrolled HIV (stable, controlled HIV allowed)
  • History of chronic lung disease requiring systemic steroids, oxygen, or hospitalization
  • Significant cardiovascular disease or QTcF >470 within 12 months before treatment
  • History of immunodeficiency or recent use of immunosuppressive therapy above specified doses
  • Known active brain metastases or carcinomatous meningitis (stable treated brain metastases allowed)
  • History of a second cancer unless treated and disease-free for 2 years (exceptions for some skin and in-situ cancers)
  • Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
  • Other illnesses or conditions that may increase risk with checkpoint inhibitor therapy as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Amir Jazeri, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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