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INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma

Study acronym: INVIGORATE
StatusRecruiting
PhasePhase 3
Started2025-11-15
View on ClinicalTrials.gov ↗

Amendment history

2026-05-13
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-01→confirmed 2025-11-15
InterventionsBevacizumab (Drug), Paclitaxel (Drug), QL1706 (bispecific antibody targeting PD-1 and CLTA-4) (Drug), carboplatin (Drug)→Bevacizumab (Drug), Paclitaxel (Drug), QL1706 (bispecific antibody targeting PD-1 and CTLA-4) (Drug), carboplatin (Drug)
Eligibility criteria+334 characters
[...] sed FIGO stage IC-IV ovarian clear cell carcinoma. Patients whoare haveplanned undergoneto undergo primary debulking surgery or interval debulking surgery after neoadjuvant chemotherapy(PDS), regardless of whether satisfactory debulking wasis achieved, and have complete surgical records and residual disease assessment results (R0 vs R1/R2). No prior treatmentfirst-line withpostoperative immunesystemic checkpointantitumor inhibitorstherapy for the current ovarian clear cell carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc. Adequate organ function confirmed by the followin [...] [...]
Secondary endpoints6 to 5 entries
Investigator-assessed PFS
Study sitesdetails revised at 1 of 1 site
2025-06-01
Original filing
Tongji Hospital
197 trials monitored
See 2 trials at risk
Ovarian Cancer
1,239 trials monitored
See 74 trials at risk
The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to \<75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are: 1. Does QL1706 plus bevacizumab, compared with standard platinum-based chemotherapy with or without bevacizumab, prolong patients' progression-free survival (PFS)? 2. What is the safety profile of QL1706 followed by QL1706 plus bevacizumab, such as what medical problems (adverse events) do participants experience? Researchers will compare QL1706 followed by QL1706 plus bevacizumab (experimental arm) with standard platinum-based chemotherapy consisting of paclitaxel plus carboplatin with or without bevacizumab (control arm) to see whether QL1706-based immunotherapy is more effective in the first-line treatment of advanced ovarian clear cell carcinoma. Participants will: 1. Be randomly assigned to receive either QL1706 alone during Cycle 1 followed by QL1706 plus bevacizumab from Cycle 2, or paclitaxel plus carboplatin with or without bevacizumab according to prespecified high-risk criteria. 2. Visit the research center regularly for drug infusions, medical examinations (such as vital signs, physical exams, laboratory tests), and tumor imaging assessments. 3. Complete quality of life questionnaires as required.
Trial Details
NCT Number NCT07002346
Lead Sponsor Tongji Hospital
Collaborators: Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Fudan University, Sun Yat-Sen University Cancer Center, Peking University Cancer Hospital & Institute, Peking University People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Renmin Hospital of Wuhan University, Zhejiang Provincial People's Hospital, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Shanghai First Maternity and Infant Hospital, Hubei Cancer Hospital, Sir Run Run Shaw Hospital, Wuhan Central Hospital, Zhejiang Cancer Hospital, The First Affiliated Hospital of Zhengzhou University, Third Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, Henan Cancer Hospital, Jiangsu Cancer Institute & Hospital, The International Peace Maternity & Child Health Hospital of China welfare institute, Women's Hospital School Of Medicine Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Zhejiang University
Conditions Ovarian Clear Cell Carcinoma
Enrollment 226 participants
Start Date 2025-11-15
Primary Completion 2027-06-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-18