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)

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called the DAB OCC Study, is investigating a new treatment approach for women with recurrent and persistent clear cell ovarian cancer. The study will explore the combination of three medications: disitamab vedotin (RC48), AK104 (a type of immunotherapy that helps the body fight cancer), and bevacizumab (which works by blocking the growth of blood vessels that tumors need to grow). The goal is to see if this combination can help improve outcomes for patients with this specific type of ovarian cancer.

To be eligible for this trial, participants need to have a confirmed diagnosis of clear cell ovarian cancer, and at least 70% of their tumor must be clear cell type. Candidates can include women who have not yet received treatment or those who have experienced their cancer returning after treatment. However, they should have had no more than two previous lines of chemotherapy. Participants will be monitored closely during the study, and they will need to provide informed consent to join. It’s important to note that patients who have received certain previous cancer treatments or have specific health conditions may not qualify for this trial.

Gender

FEMALE

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.
• • 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 with a history of immunotherapy, including treatments targeting PD-1, PD-L1, CAR-T, and CTLA-4.
• • 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.