METASTATIC CERVICAL CANCER
Conditions
Brief summary
This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab
Detailed description
Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS \< 1 vs 1 ≤ CPS \< 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab
Interventions
DRUGQL1706
Intravenous Infusion
DRUGPlacebo
Intravenous Infusion
DRUGPaclitaxel injection
Intravenous Infusion
Intravenous Infusion
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS by BICR based on RECIST v1.1 | Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months) | PFS by BICR based on RECIST v1.1 |
| OS | From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years | OS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria | Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months | PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria |
Countries
China
Contacts
Primary ContactXiaoli Zhang
Outcome results
None listed