RC48 in Combination With AK104 and Bevacizumab in OCCC
ConditionOvary Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Disitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer
DrugDisitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
Objective response rate of advanced or recurrent ovarian clear cell carcinoma
Time frame
2 yearsSecondary outcomes
1
Time to progress
Time to progress of advanced or recurrent ovarian clear cell carcinoma
Time frame
2 years2
Adverse event
Adverse event rate of treatment with RC48 in combination with AK104 and bevacizumab
Time frame
2 years3
The time to the first subsequent therapy
The time to the first subsequent therapy for enrolled patients
Time frame
2 years4
Time to response
Time to response for enrolled patients
Time frame
2 yearsOther outcomes
1
Biomarker
Explore biomarkers for predicting the response of OCCC to combination therapy, including but not limited to PD-L1, TMB, MMRd, MSI-H, HRR related genes, and lymphocyte infiltration
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov