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

Phase 3

Recruiting

• Conditions: METASTATIC CERVICAL CANCER
• Interventions: Drug: Placebo; Drug: QL1706; Drug: Paclitaxel injection; Drug: Cisplatin/Carboplatin

• Registration Number: NCT05446883
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-07
• Study Start: 2022-09-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-30
• Primary Completion: 2024-09-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 498

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL1706+chemotherapy± bevacizumab	Paclitaxel injection	QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
QL1706+chemotherapy± bevacizumab	Cisplatin/Carboplatin	QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Placebo+chemotherapy± bevacizumab	Placebo	Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Placebo+chemotherapy± bevacizumab	Paclitaxel injection	Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Placebo+chemotherapy± bevacizumab	Cisplatin/Carboplatin	Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
QL1706+chemotherapy± bevacizumab	QL1706	QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Liaoning Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China