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Cervical CancerPhase 2/3NCT04864782

QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer

A Phase 2/3 study testing QL1604, Paclitaxel injection and Cisplatin/Carboplatin in people with Cervical Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cervical Cancer
What is being tested?
QL1604, Paclitaxel injection and Cisplatin/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
23 Sep 2020to 1 Nov 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangzhou, 510060

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Cervical Cancer
Being tested
QL1604, Paclitaxel injection, Cisplatin/Carboplatin
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1604Drug

    Also called PD-1 monoclonal antibody

    Intravenous Infusion

  • Paclitaxel injectionDrug

    Intravenous Infusion

  • Cisplatin/CarboplatinDrug

    Intravenous Infusion

Study groups in NCT04864782
Study groupRoleWhat they receive
QL1604+ChemotherapyExperimentalOn 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)
Receives: Drug: QL1604; Drug: Paclitaxel injection; Drug: Cisplatin/Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with adverse events

    The incidence and severity of adverse events (AE),serious adverse events (SAE) and treatment-emergent adverse events (TEAEs) according to CTCAE V5.0

    Measured: Up to 90 days from last dose

  2. Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST

    Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST

    Measured: approximately 2 years

Secondary outcomes (12)

  1. Progression-free survival (PFS) as assessed by investigator based on RECIST v1.1 and iRECIST

    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)

    Measured: approximately 2 years

  2. Overall survival(OS)

    Overall survival(OS) is defined as the time from randomization to death due to any cause

    Measured: approximately 2 years

  3. Duration of response(DOR)

    Duration of response(DOR) as assessed by investigator based on RECIST v1.1 and iRECIST

    Measured: approximately 2 years

  4. Time to progress (TTP)

    Time to progress (TTP) as assessed by investigator based on RECIST v1.1 and iRECIST

    Measured: approximately 2 years

  5. AUC of QL1604

    Area under curve from zero to infinity

    Measured: approximately 1 years

  6. Cmax of QL1604

    Peak concentration

    Measured: approximately 1 years

  7. Cmin of QL1604

    The trough value at steady state

    Measured: approximately 1 years

  8. Tmax of QL1604

    Time to Cmax

    Measured: approximately 1 years

  9. T1/2 of QL1604

    Half life

    Measured: approximately 1 years

  10. Vss of QL1604

    Steady-state apparent volume of distribution based on plasma concentration

    Measured: approximately 1 years

  11. CLT(total body clearance) of QL1604

    Total body clearance

    Measured: approximately 1 years

  12. Immunogenicity

    The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab)

    Measured: approximately 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start23 Sep 2020
  3. Primary completion30 Sep 2022
  4. Study completion1 Nov 2023

Why it stopped: Phase 2 completed, phase 3 sponsor decided to terminate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864782
Sponsor's protocol ID
QL1604-301
Status last verified
Jan 2024
First submitted
4 Dec 2020
Last updated
12 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing QL1604, Paclitaxel injection and Cisplatin/Carboplatin in people with Cervical Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Phase 2 completed, phase 3 sponsor decided to terminate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with adverse events (time frame: Up to 90 days from last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04864782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

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