A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer

Completed · Phase 2

Conditions studied: Recurrent Cervical Cancer, Metastatic Cervical Cancer

In brief

This is a Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.

Key facts

Study ID

NCT04380805

Run by

Akeso

People needed

30

Starts

2020-07-15

Expected to finish

2023-01-31

Last updated by the study team

2025-02-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
• Women aged ≥18 years at the time of study entry.
• Subjects must have histologically or cytologically confirmed recurrent or metastatic squamous carcinoma or adenosquamous carcinoma of the cervix, and meet the following criteria: disease progression confirmed by radiologic imaging during or following prior platinum based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer; No more than 2 prior systemic therapies in the recurrent or metastatic setting.
• Subjects must have measurable lesions according to RECIST v1.1. The presence of measurable lesions must be confirmed by the IRRC. A previously irradiated lesion is not considered measurable and cannot be selected as a target lesion.
• Available archived tumor tissue sample - block or a minimum of 10 unstained slides of formalin fixed paraffin embedded [FFPE] tissues - preferably from the most recent biopsy of a tumor lesion collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease has been made.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Life expectancy ≥12 weeks.
• Adequate organ function.

You may not qualify if…

• Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
• Histological types of cervical cancer other than squamous carcinoma and adeno-squamous carcinoma (eg, adenocarcinoma, small cell carcinoma, clear cell carcinoma, sarcoma, etc).
• Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, such as basal cell skin cancer, or carcinoma in situ of the breast.
• Brain/central nervous system (CNS) metastases.
• Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent
• Active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 4 weeks prior to the first dose of investigational product.
• Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
• Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results).
• Active or prior documented autoimmune disease that may relapse.
• History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.
• Patients with clinically significant cardio-cerebrovascular disease.
• Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of toxicities not considered a safety risk.
• History of severe hypersensitivity reactions to other mAbs.
• Prior allogeneic stem cell transplantation or organ transplantation.
• Known allergy or reaction to any component of the AK104 formulation.
• Receipt of the following treatments or procedures: anticancer small molecule targeted agent within 2 weeks, radiation therapy within 2 weeks, other anticancer therapy within 4 weeks, any major surgery within 4 weeks, any other investigational product or procedure within 4 weeks, or agents with immunomodulatory effect within 2 weeks prior to the first dose of investigational product.
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily doses of prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of investigational product.
• Receipt of live attenuated vaccines within 30 days prior to the first dose of investigational product.
• Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

Where it is running

• Womens Cancer Research Foundation — Newport Beach, California, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• BRCR Medical Center — Plantation, Florida, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Maryland Oncology Hematology (Plum Orchard) — Silver Spring, Maryland, United States
• Monter Cancer Center — Lake Success, New York, United States
• The Blavatnik Family - Chelsea Medical Center at Mount Sinai — New York, New York, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa, Oklahoma, United States
• Chattanooga's Program In Women's Oncology — Chattanooga, Tennessee, United States
• Tennessee Oncology - Centennial Clinic — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Texas Oncology-Fort Worth Cancer Center — Fort Worth, Texas, United States
• Lyndon B. Johnson Hospital (MD Anderson) — Houston, Texas, United States
• Texas Oncology (Woodlands) — The Woodlands, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Pacific Gynecology Specialists, P. C. — Seattle, Washington, United States
• Monash Health — Clayton, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Ashford Cancer Centre Research — Adelaide, Australia
• Blacktown Hospital — Blacktown, Australia
• ICON Cancer Centre — Brisbane, Australia
• Auckland City Hospital — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

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