Disitamab vedotin (RC48) with AK104 and bevacizumab for recurrent or persistent clear cell ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, phase II multicenter trial of disitamab vedotin (RC48) combined with AK104 and bevacizumab in patients with recurrent or persistent ovarian clear cell carcinoma. The rationale is that anti-angiogenic therapy and immune checkpoint modulation may synergize in this tumor type and that HER2-directed ADCs can both directly kill tumor cells and modulate anti-tumor immunity. Key eligibility includes pathologically confirmed OCCC (≥70% clear cell if mixed), HER2 IHC ≥1+, at least one measurable lesion by RECIST 1.1, and up to two prior lines of chemotherapy. The study will administer the three-drug combination and measure anti-tumor activity and safety outcomes including response rate and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jing Li, doctor
• Email: lijing228@mail.sysu.edu.cn
• Phone: 15915893493

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Disitamab vedotin plus bevacizumab for HER2-low metastatic breast cancer after T‑DxD failure

  This study will try disitamab vedotin combined with bevacizumab in adults with HER2‑low metastatic breast cancer whose disease progressed after trastuzumab deruxtecan.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07446452

• Disitamab vedotin plus carboplatin and bevacizumab as first-line and maintenance treatment for HER2-expressing, HRD-negative high-risk ovarian cancer

  This study tests whether adding disitamab vedotin to carboplatin and bevacizumab helps people with HER2-expressing, HRD-negative high-risk ovarian cancer as first-line and maintenance treatment.

  Recruiting Phase 2 Jiangsu Cancer Institute & Hospital · Nanjing, Jiangsu and 1 other locations · NCT07311577

• RC48 with bevacizumab or pyrotinib for HER2-positive metastatic breast cancer after T-Dxd failure

  This trial will try RC48 together with either bevacizumab or pyrotinib in adults with HER2-positive metastatic breast cancer whose disease has progressed after trastuzumab deruxtecan (T-Dxd).

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07065435

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• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.