Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04380805
Other study ID # AK104-201-AU
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 15, 2020
Est. completion date September 15, 2022

Study information

Verified date October 2022
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 15, 2022
Est. primary completion date August 29, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Able to provide written and signed informed consent and any locally required authorization obtained from the subject/legal representative. 2. Women aged =18 years at the time of study entry. 3. 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. 4. 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. 5. 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. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 7. Life expectancy =12 weeks. 8. Adequate organ function. Exclusion Criteria: 1. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study. 2. Histological types of cervical cancer other than squamous carcinoma and adeno-squamous carcinoma (eg, adenocarcinoma, small cell carcinoma, clear cell carcinoma, sarcoma, etc). 3. 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. 4. Brain/central nervous system (CNS) metastases. 5. Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent 6. Active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 4 weeks prior to the first dose of investigational product. 7. Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome. 8. 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). 9. Active or prior documented autoimmune disease that may relapse. 10. History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies. 11. Patients with clinically significant cardio-cerebrovascular disease. 12. 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. 13. History of severe hypersensitivity reactions to other mAbs. 14. Prior allogeneic stem cell transplantation or organ transplantation. 15. Known allergy or reaction to any component of the AK104 formulation. 16. 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. 17. 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. 18. Receipt of live attenuated vaccines within 30 days prior to the first dose of investigational product. 19. 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). 20. 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.

Study Design


Intervention

Biological:
AK104
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Akeso Akesobio Australia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC) Up to 2 years
Secondary ORR assessed by Investigator The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1. Up to 2 years
Secondary Disease control rate (DCR) The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for =8 weeks) based on RECIST Version 1.1. Up to 2 years
Secondary Duration of Response (DoR) Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. Up to 2 years
Secondary Progression-free survival (PFS) Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first. Up to 2 years
Secondary 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
Secondary Minimum observed concentration (Cmin) of AK104 at steady state From first dosing date of AK104 through 30 days post last dose of AK104, up to 2 years
Secondary Number of subjects who develop detectable anti-drug antibodies From first dosing date of AK104 through 90 days post last dose of AK104, up to 2 years
See also
  Status Clinical Trial Phase
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01764789 - Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer N/A
Active, not recruiting NCT04341883 - Study of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer Phase 2
Completed NCT01652794 - Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer Phase 1
Completed NCT01079832 - Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies Phase 2
Completed NCT00335998 - Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies Phase 1
Completed NCT00031993 - Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix Phase 2
Completed NCT01155258 - Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors Phase 1
Recruiting NCT04974944 - First-line Treatment With Camrelizumab + Apatinib Versus Chemotherapy + Bevacizumab in Advanced Cervical Cancer Phase 2
Completed NCT00941070 - Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer Phase 2
Completed NCT02849340 - Combination of Cryosurgey and NK Immunotherapy for Recurrent Cervical Cancer Phase 1/Phase 2
Completed NCT00389974 - Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery Phase 2
Completed NCT00031681 - 7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) Phase 1
Completed NCT00030498 - Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Phase 1
Recruiting NCT04191226 - Genetic Mutation in Recurrent Cervical Cancer
Completed NCT01676818 - Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer Phase 2
Completed NCT00004074 - Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu Phase 1
Completed NCT00025233 - Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix Phase 2
Terminated NCT04230954 - Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer Phase 2
Withdrawn NCT01313104 - Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer N/A