QL1706 combined with chemotherapy for treating advanced cervical cancer
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate QL1706 Plus Paclitaxel-Cisplatin/Carboplatin With or Without Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
This study is testing if adding a new treatment called QL1706 to standard chemotherapy can help people with advanced cervical cancer feel better and improve their outcomes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 498 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | bevacizumab, ramucirumab, immunotherapy, methotrexate, cyclophosphamide, prednisone, Chemotherapy |
| Locations | 3 sites (Chongqing, Chongqing and 2 other locations) |
| Trial ID | NCT05446883 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the efficacy of QL1706 in combination with standard chemotherapy (Paclitaxel-cisplatin/Carboplatin) with or without Bevacizumab for patients with persistent, recurrent, or metastatic cervical cancer. The study involves 498 participants who will be randomized into two groups: one receiving the experimental treatment and the other receiving a placebo alongside chemotherapy. Patients will be stratified based on prior treatments and PD-L1 expression levels to ensure appropriate matching. Archival or newly obtained tumor tissue samples are required for eligibility to assess PD-L1 levels.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed cervical cancer who have measurable tumor lesions and meet specific health criteria.
Not a fit: Patients who have previously received immunotherapy or VEGF/VEGFR inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced cervical cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and targeted therapies in treating advanced cervical cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject fully understood and voluntarily signed the informed consent form. * Histologically confirmed cervical cancer. * At least one measurable tumor lesion by CT or MRI according to RECIST 1.1 criteria. * All subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained FFPE pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected survival ≥ 12 weeks. * Adequate level of vital organ function Exclusion Criteria: * Previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; previously received VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors. * Systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever \> 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator) * Within two weeks before randomization, there is a need for systemic use of corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) treatment of the disease; Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are permitted for the prevention of contrast allergy。 * Systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization
Where this trial is running
Chongqing, Chongqing and 2 other locations
- Chongqing University Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xiaoli Zhang
- Email: xiaoli3.zhang@qilu-pharma.com
- Phone: 008610-50813552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.