QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic 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
1 other identifier
interventional
498
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2022
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedStudy Start
First participant enrolled
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedNovember 30, 2022
November 1, 2022
1.9 years
June 28, 2022
November 24, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
PFS by BICR based on RECIST v1.1
PFS by BICR based on RECIST v1.1
Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
OS
OS
From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
Secondary Outcomes (1)
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
Study Arms (2)
QL1706+chemotherapy± bevacizumab
EXPERIMENTALQL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Placebo+chemotherapy± bevacizumab
PLACEBO COMPARATORPlacebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Interventions
Intravenous Infusion
Intravenous Infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
Related Publications (1)
Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.
PMID: 37158938DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 7, 2022
Study Start
September 23, 2022
Primary Completion
September 1, 2024
Study Completion
July 1, 2025
Last Updated
November 30, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share
Involves subject privacy and does not intend to share