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Recruiting NCT06540729

RC48 in Combination With AK104 and Bevacizumab in OCCC

Conditions: Ovary Cancer

Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 39
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Location: Sun Yat-sen Memorial Hospital Guanzhou Guangdong

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 reactions, with a maximum of 2 lines of chemotherapy post-recurrence. * Previous utilization of bevacizumab is permissible. * Adequate bone marrow reserve function necessitates pre-operative blood routine parameters meeting specific criteria: white blood cell count ≥3.0×10\^9/L, neutrophil count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, and hemoglobin ≥80 g/L. * atisfactory organ function entails biochemical test results within defined limits: AST ≤2.5× upper limit of normal (ULN), ALT ≤2.5× ULN, serum total bilirubin ≤1.5× ULN, and creatinine ≤1.5× ULN. * ECOG performance status score ranging from 0 to 1. * Patient participation is contingent upon voluntary execution of an informed consent form. Exclusion Criteria: * Patients diagnosed with other malignancies within the past five years, excluding skin cancer and thyroid cancer. * Patients with an expected survival of ≤12 weeks. * Patients with a known allergy to taxane-based medications. * Patients who, based on clinical assessment, have contraindications for receiving immunotherapy and/or bevacizumab, such as uncontrolled infections, gastrointestinal fistula, autoimmune diseases, active hepatitis, or active bleeding. Patients currently undergoing treatment with investigational anti-cancer drugs in other clinical trials. * Patients with any unstable condition or situation that may compromise their safety or adherence to the study protocol.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06540729). StuddyBuddy aggregates publicly available trial information.