Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, open-label, phase II clinical study conducted in China. All subjects will receive AK104 in combination with standard treatment regimens or AK104 alone. The primary end point is safety. The secondary end point is efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104+Paclitaxel+Cisplatin/Carboplatin | Experimental | AK104 intravenously(IV) every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W) |
|
| AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin | Experimental | AK104 every 3 weeks (Q3W) Bevacizumab 15mg/kg IV every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W) |
|
| AK104 | Experimental | AK104 IV every 2 weeks (Q2W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Biological | Subjects will receive AK104 intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment | From the time of informed consent signed through 90 days after the last dose of AK104 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | Up to 2 years |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jing Wang, MD | Hunan Cancer Hospital | Principal Investigator |
| Hanmei Lou | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China | ||
| Zhejiang Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38372727 | Derived | Lou H, Cai H, Huang X, Li G, Wang L, Liu F, Qin W, Liu T, Liu W, Wang ZM, Li B, Xia Y, Wang J. Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study. Clin Cancer Res. 2024 Apr 15;30(8):1501-1508. doi: 10.1158/1078-0432.CCR-23-3162. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002583 | Uterine Cervical Neoplasms |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bevacizumab | Biological | Subjects will receive Bevacizumab intravenously. |
|
| Paclitaxel | Drug | Subjects will receive Paclitaxel intravenously. |
|
|
| Cisplatin or Carboplatin | Drug | Subjects will receive Cisplatin or Carboplatin intravenously. |
|
|
| Up to 2 years |
| 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 |
| 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 |
| Overall survival (OS) | Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause. | Up to 2 years |
| Minimum observed concentration (Cmin) of AK104 at steady state | The endpoints for assessment of PK of AK104 include serum concentrations of AK105 at different timepoints after AK104 administration. | From first dose of AK104 through 30 days after last dose of AK104 |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). | From first dose of AK104 through 30 days after last dose of AK104 |
| Expression of PD-L1 in tumor tissue samples | PD-L1 expression will be determined by IHC in the central laboratory. | Baseline (Tumor tissue samples must be provided to the research center or central laboratory prior to initial administration) |
| Hangzhou |
| Zhejiang |
| 310022 |
| China |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |