Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540729
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Disitamab Vedotin RC48 in Combination With AK104 PD-1CTLA-4 Bispecific and Bevacizumab for the Treatment of Recurrent and Persistent Clear Cell Ovarian Cancer a Single-arm Phase II Multicenter Study DAB OCC Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Disitamab Vedotin RC48 in Combination With AK104 PD-1CTLA-4 Bispecific and Bevacizumab for the Treatment of Recurrent and Persistent Clear Cell Ovarian Cancer a Single-arm Phase II Multicenter Study DAB OCC Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAB
Brief Summary:
Disitamab vedotin RC48 in combination with AK104 PD-1CTLA-4 bispecific and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer a single-arm phase II multicenter study DAB OCC study
Detailed Description:
Ovarian clear cell carcinoma OCCC ranks as the second most common epithelial ovarian malignancy in Asian women characterized by extremely poor prognosis with a median overall survival OS of 253 months OCCC demonstrates a dismal response rate to conventional chemotherapy and once in a state of persistence or recurrence treatments become severely limited with a mere 5-year survival rate of 132 with over two-thirds of patients succumbing within 1 year Thus there is an urgent need to explore new therapeutic approaches for recurrent and persistent OCCC patients Evidence suggests that anti-angiogenesis therapy is effective against OCCC which tends to exhibit a hot tumor phenotype Hence the combination of anti-angiogenesis therapy with immunotherapy holds promise for recurrent and persistent OCCC Additionally overexpression of human epidermal growth factor receptor 2 HER2 plays a pivotal role in OCCC resistance formation Antibody drug conjugates ADCs targeting HER2 have shown increasing efficacy in ovarian cancer treatment with significant immunomodulatory effects enhancing the efficacy of immunotherapy Based on this evidence we hypothesize that the combination of anti-angiogenesis therapy immunotherapy and HER2-targeted ADCs may improve the prognosis of OCCC patients Therefore we are initiating this clinical study aimed at evaluating the efficacy and safety of vedolizumab HER2-targeted ADC in combination with AK104 anti-PD-1 and CTLA4 and bevacizumab anti-angiogenesis in recurrent and persistent OCCC patients vedolizumab 25 mgkg AK104 10 mgkg bevacizumab 15 mgkg every 3 weeks with the aim of providing new treatment options for these refractory gynecologic malignancies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None