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

Primary Purpose

METASTATIC CERVICAL CANCER

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

QL1706

Placebo

Paclitaxel injection

Cisplatin/Carboplatin

About this trial

This is an interventional treatment trial for METASTATIC CERVICAL CANCER

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Chongqing University Cancer HospitalRecruiting
Sun Yat-sen University Cancer CenterRecruiting
Liaoning Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QL1706+chemotherapy± bevacizumab

Placebo+chemotherapy± bevacizumab

Arm Description

QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

Outcomes

Primary Outcome Measures

PFS by BICR based on RECIST v1.1

Secondary Outcome Measures

PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria

Full Information

NCT ID

NCT05446883

First Posted

June 28, 2022

Last Updated

November 24, 2022

Sponsor

Qilu Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05446883

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 23, 2022 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

METASTATIC CERVICAL CANCER

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

498 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

QL1706+chemotherapy± bevacizumab

Arm Type

Experimental

Arm Description

QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

Arm Title

Placebo+chemotherapy± bevacizumab

Arm Type

Placebo Comparator

Arm Description

Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

Intervention Type

Drug

Intervention Name(s)

QL1706

Intervention Description

Intravenous Infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous Infusion

Intervention Type

Drug

Intervention Name(s)

Paclitaxel injection

Intervention Description

Intravenous Infusion

Intervention Type

Drug

Intervention Name(s)

Cisplatin/Carboplatin

Intervention Description

Intravenous Infusion

Primary Outcome Measure Information:

Title

PFS by BICR based on RECIST v1.1

Description

PFS by BICR based on RECIST v1.1

Time Frame

Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)

Title

Description

Time Frame

From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcome Measure Information:

Title

PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria

Description

PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria

Time Frame

Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoli Zhang

Phone

008610-50813552

xiaoli3.zhang@qilu-pharma.com

Facility Information:

Facility Name

Chongqing University Cancer Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qi Zhou

First Name & Middle Initial & Last Name & Degree

Dongling Zou

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jihong Liu, Doctor

Phone

13826299236

LiuJH@sysucc.org.cn

Facility Name

Liaoning Cancer Hospital

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danbo Wang

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Involves subject privacy and does not intend to share

Learn more about this trial

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

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