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

Sponsor
Tongji Hospital
Study ID
NCT07002346
Phase
PHASE3
Status
Recruiting
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Conditions

  • Ovarian Clear Cell Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 (bispecific antibody targeting PD-1 and CTLA-4) — DRUG
    QL1706: 5 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 2 years.
  • Bevacizumab — DRUG
    Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 22 cycles.
  • carboplatin — DRUG
    Carboplatin: AUC=5, intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 6 cycles
  • Paclitaxel — DRUG
    Paclitaxel: 175 mg/m\^2 intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 6 cycles

Study Details

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.

Key Dates

First listed
Jun 3, 2025
Start date
Nov 15, 2025
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2029

Study Design

Enrollment
226 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm: QL1706 + Bevacizumab
    QL1706 5 mg/kg Q3W (D1)+Bevacizumab 15mg/kg Q3W (D1) (QL1706/Bevacizumab treatment for a maximum of 2 years/22 cycles)
  • Active Comparator: Control Arm: Paclitaxel + Carboplatin ± Bevacizumab
    Paclitaxel 175 mg/m² Q3W (D1) + Carboplatin AUC 5 Q3W (D1), for 6 cycles, with or without Bevacizumab 15 mg/kg Q3W (D1) according to prespecified high-risk criteria. Bevacizumab may be continued until disease progression, unacceptable toxicity, or completion of a maximum of 22 cycles.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 4 years ]

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