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

NCT04380805 | Completed Phase 2 FDA Drug

• 1 other identifier: AK104-201-AU
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 25

Brief Summary

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.

Conditions

Recurrent Cervical Cancer; Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC)

  Up to 2 years

Secondary Outcomes (7)

• ORR assessed by Investigator

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of Response (DoR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Number of participants with adverse events (AEs)

  From the time of informed consent signed through 30 days after the last dose, up to 2 years

Study Arms (1)

AK104

EXPERIMENTAL

AK104 monotherapy

Biological: AK104

Interventions

AK104 BIOLOGICAL

All subjects will receive AK104 as a single agent at a dose of 6 mg/kg Q2W (Day 1 and Day 15 of each 28 day treatment cycle) via IV infusion.

AK104

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Akeso: lead
• Akesobio Australia Pty Ltd: collaborator

Study Sites (25)

Womens Cancer Research Foundation

Newport Beach, California, 92663, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

BRCR Medical Center

Plantation, Florida, 33322, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005-2380, United States

Location

Maryland Oncology Hematology (Plum Orchard)

Silver Spring, Maryland, 20904, United States

Location

Monter Cancer Center

Lake Success, New York, 11042, United States

Location

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York, 10011, United States

Location

Oncology Hematology Care Inc

Cincinnati, Ohio, 45242, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Chattanooga's Program In Women's Oncology

Chattanooga, Tennessee, 37403, United States

Location

Tennessee Oncology - Centennial Clinic

Nashville, Tennessee, 37203, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

Lyndon B. Johnson Hospital (MD Anderson)

Houston, Texas, 77026, United States

Location

Texas Oncology (Woodlands)

The Woodlands, Texas, 77380, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Pacific Gynecology Specialists, P. C.

Seattle, Washington, 98104, United States

Location

Monash Health

Clayton, Victoria, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Location

Ashford Cancer Centre Research

Adelaide, Australia

Location

Blacktown Hospital

Blacktown, Australia

Location

ICON Cancer Centre

Brisbane, Australia

Location

Auckland City Hospital

Grafton, Auckland, New Zealand

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Leslie Randall, MD

  Virginia Commonwealth University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 8, 2020
• Study Start: July 15, 2020
• Primary Completion: December 22, 2022
• Study Completion: January 31, 2023
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); US (19); NZ (1)