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Recruiting Phase 2 NCT06540729

RC48 in Combination With AK104 and Bevacizumab in OCCC

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Trial Parameters

Condition Ovary Cancer
Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 39
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2024-09-24
Completion 2028-08-01
Interventions
Disitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer

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Brief Summary

Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-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)

Eligibility Criteria

Inclusion Criteria: * The pathological diagnosis confirms ovarian clear cell carcinoma. In cases of mixed carcinoma, a prerequisite is that clear cell carcinoma constitutes at least 70% of the tumor mass. Moreover, adherence to RECIST 1.1 criteria mandates the presence of at least one evaluable lesion. * HER2 IHC ≥1+. * Treatment-naïve individuals encompass those experiencing tumor progression during postoperative chemotherapy and those who, following platinum-containing neoadjuvant chemotherapy, have not undergone surgical intervention yet and subsequently manifested progression during or after platinum-containing chemotherapy, provided that they have received a maximum of 2 prior lines of chemotherapy. * Recurrent patients, whether platinum-sensitive or platinum-resistant, include those lacking a platinum-free interval of ≥6 months and who, post-recurrence, have undergone re-administration of platinum-containing chemotherapy but have demonstrated an inability to tolerate toxic reacti

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