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NOT YET RECRUITING
NCT07002346
PHASE3

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

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if QL1706 combined with bevacizumab can effectively treat adult female patients (18 to \<75 years old) with newly diagnosed FIGO stage IC-IV advanced ovarian clear cell carcinoma. The main questions it aims to answer are: 1. Does QL1706 combined with bevacizumab, compared to platinum-based chemotherapy, prolong patients' progression-free survival (PFS)? 2. What is the safety profile of QL1706 combined with bevacizumab, such as what medical problems (adverse events) do participants experience? Researchers will compare QL1706 combined with bevacizumab (experimental arm) to a standard chemotherapy regimen of paclitaxel plus carboplatin (control arm) to see if QL1706 combined with bevacizumab is more effective in the first-line treatment of advanced ovarian clear cell carcinoma. Participants will: 1. Be randomly assigned to receive either QL1706 combined with bevacizumab (QL1706 administered every 3 weeks, bevacizumab administered every 3 weeks) or paclitaxel plus carboplatin chemotherapy (administered every 3 weeks). 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.

Official title: Randomized Active-controlled Trial Evaluating QL1706 Plus Bevacizumab Versus Platinum-Based Chemotherapy for Advanced First-Line Ovarian Clear Cell Carcinoma

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2025-06-01

Completion Date

2029-06-01

Last Updated

2025-06-03

Healthy Volunteers

No

Interventions

DRUG

QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

QL1706: 5 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 2 years.

DRUG

Bevacizumab

Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 22 cycles.

DRUG

carboplatin

Carboplatin: AUC=5, intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 6 cycles

DRUG

Paclitaxel

Paclitaxel: 175 mg/m\^2 intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 6 cycles

Locations (1)

Tongji Hospital

Wuhan, Hubei, China