- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864782
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
January 10, 2024 updated by: Qilu Pharmaceutical Co., Ltd.
A Study of QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
The purpose of this study is to evaluate the efficacy and safety of PD-1 Inhibitor (QL1604) plus chemotherapy in patients with Stage IV, recurrent, or metastatic cervical cancer.
Possible chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted in 2 parts.The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meimei Si, MM
- Phone Number: 010-50813552
- Email: meimei.si@qilu-pharma.com
Study Locations
-
-
Guangzhou
-
Guangzhou, Guangzhou, China, 510060
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years and ≤ 75 years
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- At least one measurable lesion (according to RECIST v1.1)
- Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma diagnosed by histopathology and confirmed by imaging as recurrent or stage ⅣB cervical cancer.
- No brain metastasis, or no meningeal metastasis.
Patients must have normal function as defined:
- ANC≥1.5*10^9/L; PLT≥90*10^9/L, Hb≥90 g/L,
- Total Bilirubin (TBIL)≤1.5*Upper Limit of Normal(ULN), Alanine Transaminase (ALT)and Aspartate Aminotransferase(AST)≤2.5*ULN.For liver metastasis patients, ALT and AST≤5*ULN,
- Cr≤ 1.5*ULN, or creatinine clearance rate ≥50 mL/min,
- Proteinuria <2+,if proteinuria≥ 2+ and 24 hours total urine protein < 1.0 g
- LVEF≥ 50%.
- Any unresolved AEs ≤ CTCAE Grade 1 (except alopecia).
- Negative pregnancy test for females of child-bearing potentials.
- Patients with reproductive function agreed to take effective contraceptive measures during the treatment and in 6 months after the end of administration.
- Patients must be able to understand and volunteer to sign the informed consent.
Exclusion Criteria:
- Has received more than 2 courses of palliative chemotherapy for treatment of cervical cancer.
- Has received prior chemoradiotherapy within 3 months before enrollment,or has received prior radiotherapy within 2 weaks before enrollment.
- Has received prior surgery therapy within 2 weaks before enrollment,or has not recovered from the effects of surgery therapy.
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks before enrollment.
- Has any active autoimmune diseases or a history of autoimmune diseases (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included).
- Is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the QL1604 formulation, or any components of the study drugs.
- Has uncontrolled clinically significant cardiac and cerebral vascular diseases within 6 months before enrollment, including but not limited to the following: myocardial infarction, severe or unstable angina, coronary artery/peripheral artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack).
- Symptomatic congestive heart failure (New York Heart Association Grade II-IV), or NCI-CTCAE v5.0 ≥ 2 arrhythmia, atrial fibrillation of any grade, or clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention.
- Has active infection or an unexplained fever > 38.5°C during screening visits( subjects with tumor fever may be enrolled at the discretion of the investigator).
- Hepatitis b surface antigen (HBsAg) positive and/or hepatitis b core antibody (HBcAb) positive and HBVDNA>103copies/ml, hepatitis c virus antibody positive .
- Known history of human immunodeficiency virus (HIV) infection, or other acquired or congenital immunodeficiency diseases,or has a history of organ transplantation (except corneal transplantation).
- Has been vaccinated with live anti-tumor vaccine, or have received anti-tumor immunotherapy, or may receive other systemic anti-tumor treatments during the study period.
- Peripheral neuropathy≥ CTCAE Grade 2.
- History of psychotropic substance abuse, alcoholism or drug abuse.
- Has a clear history of neurological or mental disorders, including epilepsy or dementia.
- Patients with other malignancies witnin 5 years( except cured basal cell carcinoma of skin cancer, papillary thyroid carcinoma).
- At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study,such as unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 160 mmHg, diastolic blood pressure > 110 mmHg), serious diabetes, thyroid diseases, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QL1604+Chemotherapy
On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of QL1604 200 mg plus Investigator choice of chemotherapy (paclitaxel 175 mg/m^2 plus cisplatin 70 mg/m^2 or paclitaxel 175 mg/m^2 plus carboplatin Area Under the Curve (AUC) 6)
|
Intravenous Infusion
Intravenous Infusion
Other Names:
Intravenous Infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with adverse events
Time Frame: Up to 90 days from last dose
|
The incidence and severity of adverse events (AE),serious adverse events (SAE) and treatment-emergent adverse events (TEAEs) according to CTCAE V5.0
|
Up to 90 days from last dose
|
Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST
Time Frame: approximately 2 years
|
Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST
|
approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival(OS)
Time Frame: approximately 2 years
|
Overall survival(OS) is defined as the time from randomization to death due to any cause
|
approximately 2 years
|
AUC of QL1604
Time Frame: approximately 1 years
|
Area under curve from zero to infinity
|
approximately 1 years
|
Cmax of QL1604
Time Frame: approximately 1 years
|
Peak concentration
|
approximately 1 years
|
Cmin of QL1604
Time Frame: approximately 1 years
|
The trough value at steady state
|
approximately 1 years
|
Tmax of QL1604
Time Frame: approximately 1 years
|
Time to Cmax
|
approximately 1 years
|
T1/2 of QL1604
Time Frame: approximately 1 years
|
Half life
|
approximately 1 years
|
Vss of QL1604
Time Frame: approximately 1 years
|
Steady-state apparent volume of distribution based on plasma concentration
|
approximately 1 years
|
CLT(total body clearance) of QL1604
Time Frame: approximately 1 years
|
Total body clearance
|
approximately 1 years
|
Immunogenicity
Time Frame: approximately 1 years
|
The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab)
|
approximately 1 years
|
Progression-free survival (PFS) as assessed by investigator based on RECIST v1.1 and iRECIST
Time Frame: approximately 2 years
|
Progression-free survival (PFS) is defined as time from the date of randomization to the date of first documentation of disease progression or death due to any cause(whichever occurs earlier)
|
approximately 2 years
|
Duration of response(DOR)
Time Frame: approximately 2 years
|
Duration of response(DOR) as assessed by investigator based on RECIST v1.1 and iRECIST
|
approximately 2 years
|
Time to progress (TTP)
Time Frame: approximately 2 years
|
Time to progress (TTP) as assessed by investigator based on RECIST v1.1 and iRECIST
|
approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jihong Liu, Professor, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2020
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
April 25, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- QL1604-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Cisplatin/Carboplatin
-
Seoul National University HospitalNot yet recruiting
-
Eli Lilly and CompanyCompletedLung NeoplasmsUnited States
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Recruiting
-
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.Hubei Mon Yan Pharmaceutical Co., LtdUnknownNon-small-Cell Lung CancerChina
-
Hunan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
European Organisation for Research and Treatment...Terminated
-
Hunan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Recruiting
-
University Medical Center GroningenAmsterdam UMC, location VUmcCompletedHead and Neck Squamous Cell CarcinomaNetherlands
-
Massachusetts General HospitalDana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; North Shore...CompletedBreast CancerUnited States
-
Nanfang Hospital of Southern Medical UniversityRecruitingCisplatin | NPC | CarboplatinChina