A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT04380805|
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Cervical Cancer Metastatic Cervical Cancer||Biological: AK104||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 15, 2020|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||February 1, 2022|
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.
- Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC) [ Time Frame: Up to 2 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380805
|Contact: Kon Yew Kwek, BMBCh, DPhil||+86 (0760) 8987 email@example.com|
|Study Chair:||Leslie Randall, MD||Virginia Commonwealth University|