Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)

NCT05475171 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0107NCI-2022-06116
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• To establish overall survival (OS)

  through the study completion an average of 1 year.

Study Arms (1)

Lorigerlimab

EXPERIMENTAL

Participants will receive Lorigerlimab by vein over about 30 minutes on Day 1 of each cycle

Drug: Lorigerlimab

Interventions

Lorigerlimab DRUG

Given by vein (IV)

Also known as: MGD019

Lorigerlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 pathology), who will be allowed only in consultation with their physician.
• AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.

You may not qualify if:

• 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
• 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.
• 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 definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers.
• 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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
• Other illnesses/conditions that in the investigator's opinion would adversely affect the safety of checkpoint inhibitor therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• MacroGenics: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Amir Jazeri, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Jazeri, MD

CONTACT

713-745-1613; aajazaeri@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: December 13, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)