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| Name | Class |
|---|---|
| Akeso | INDUSTRY |
| Innovent Biologics, Inc. | OTHER |
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To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 1.Not systematically treated: 20 patients with recurrent or metastatic vulvar and vaginal cancers enrolled without systemic treatment (platinum-based doublet chemotherapy) will be treated with cardunolizumab + platinum-based doublet chemotherapy ± bevacizumab. 2.Previous systematic treatment: Twenty patients with recurrent or metastatic vulvar and vaginal cancers previously treated with systemic therapy (platinum-based doublet chemotherapy) will be enrolled as subjects receiving cardunolizumab ± investigator's choice of chemotherapy ± bevacizumab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardunolizumab | Drug |
Cardunolizumab (10mg/kg) + Chemotherapy regimen selected by the investigator ± Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and then Cardunolizumab ± Bevacizumab Q3W maintenance treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS is defined as the time from the start of treatment with Cardunolizumab until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanmei Lou, MD | Contact | +8619817462599 | louhm@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
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| ID | Term |
|---|---|
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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OS is defined as the time from the start of treatment with Cardunolizumab until death due to any cause.
| Up to 2 years |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1. | Up to 2 years |
| Duration of response (DOR) | DOR 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 |
| Adverse events (AEs) | Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0 | From first dose of Cardunolizumab through to 90 days after last dose of Cardunolizumab |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014845 | Vulvar Diseases |