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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380805
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Akesobio Australia Pty Ltd
Information provided by (Responsible Party):
Akeso

Tracking Information
First Submitted Date  ICMJE May 1, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date September 21, 2020
Actual Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC) [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • ORR assessed by Investigator [ Time Frame: Up to 2 years ]
    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
  • Disease control rate (DCR) [ Time Frame: Up to 2 years ]
    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.
  • Duration of Response (DoR) [ Time Frame: Up to 2 years ]
    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.
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    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.
  • Number of participants with adverse events (AEs) [ Time Frame: From the time of informed consent signed through 30 days after the last dose, up to 2 years ]
  • Minimum observed concentration (Cmin) of AK104 at steady state [ Time Frame: From first dosing date of AK104 through 30 days post last dose of AK104, up to 2 years ]
  • Number of subjects who develop detectable anti-drug antibodies [ Time Frame: From first dosing date of AK104 through 90 days post last dose of AK104, up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer
Official Title  ICMJE A Phase 2, Multicenter, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of AK104 in Subjects With Recurrent or Metastatic Cervical Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Cervical Cancer
  • Metastatic Cervical Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: AK104
AK104 monotherapy
Intervention: Biological: AK104
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kon Yew Kwek, BMBCh, DPhil +86 (0760) 8987 3999 global.trials@akesobio.com
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04380805
Other Study ID Numbers  ICMJE AK104-201-AU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Akeso
Study Sponsor  ICMJE Akeso
Collaborators  ICMJE Akesobio Australia Pty Ltd
Investigators  ICMJE
Study Chair: Leslie Randall, MD Virginia Commonwealth University
PRS Account Akeso
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP