QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

METASTATIC CERVICAL CANCER Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446883
• Other study ID #: QL1706-301
• Status: Recruiting
• Phase: Phase 3
• Start date: September 23, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2022
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Xiaoli Zhang
• Phone: 008610-50813552
• Email: xiaoli3.zhang[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 498
• Est. completion date: July 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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-a 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

Related Conditions & MeSH terms

• METASTATIC CERVICAL CANCER
• Uterine Cervical Neoplasms

Intervention

Drug:
• QL1706
Intravenous Infusion
• Placebo
Intravenous Infusion
• Paclitaxel injection
Intravenous Infusion
• Cisplatin/Carboplatin
Intravenous Infusion

Locations

Country	Name	City	State
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Liaoning Cancer Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	OS	OS	From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
Secondary	PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria	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