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

Summary

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.

Conditions

• Ovarian Clear Cell Carcinoma

Interventions

DRUG

QL1706 (bispecific antibody targeting PD-1 and CTLA-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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Sun Yat-Sen University Cancer Center

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The Second Affiliated Hospital, Sun Yat-sen University

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  collaborator OTHER

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• The International Peace Maternity & Child Health Hospital of China welfare institute

  collaborator UNKNOWN

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-15

Primary Completion

2027-06-01

Completion

2029-06-01

Countries

• China

Study Locations