RecruitingPhase 2NCT06540729

RC48 in Combination With AK104 and Bevacizumab in OCCC

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

39 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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.

Interventions

DRUGDisitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer

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


Locations(1)

Sun Yat-sen Memorial Hospital

Guanzhou, Guangdong, China

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NCT06540729


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