Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy With or Without Bevacizumab in Women With Recurrent, or Metastatic Cervical Cancer

Qilu Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: QL1706

Study type: Interventional

Funder types: Industry

Identifiers

NCT05179317

QL1706-204

Details and patient eligibility

About

This is a Phase 2, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of QL1706 Plus Chemotherapy in Women With Recurrent, or Metastatic Cervical Cancer.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years at the time of study entry.
2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Life expectancy of at least 12 weeks.
4. At least one measurable lesion (according to RECIST v1.1)
5. Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma diagnosed by histopathology and confirmed by imaging as recurrent or stage ⅣB cervical cancer.
6. No brain metastasis, or no meningeal metastasis.
7. Patients must have normal function as defined:
8. Any unresolved AEs ≤ CTCAE Grade 1 (except alopecia).
9. Negative pregnancy test for females of child-bearing potentials.
10. Patients with reproductive function agreed to take effective contraceptive measures during the treatment and in 6 months after the end of administration.
11. Patients must be able to understand and volunteer to sign the informed consent.

Exclusion criteria

1. Has received prior chemoradiotherapy within 3 months before enrollment,or has received prior radiotherapy within 2 weaks before enrollment.
2. Is currently participating in or has participated in a study of an investigational agent within 4 weeks before enrollment.
3. 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).
4. 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.
5. Known history of hypersensitivity to macromolecular protein preparation or any components of the QL1604 formulation, or any components of the study drugs.
6. 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).
7. 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.
8. 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).
9. Hepatitis b surface antigen (HBsAg) positive and/or hepatitis b core antibody (HBcAb) positive and HBVDNA>103copies/ml, hepatitis c virus antibody positive .
10. 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).
11. 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.
12. Has a clear history of neurological or mental disorders, including epilepsy or dementia.
13. Patients with other malignancies witnin 5 years( except cured basal cell carcinoma of skin cancer, papillary thyroid carcinoma).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

QL1706+chemotherapy±Bevacizumab

Experimental group

Description:

On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of QL1706 5mg/kg 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 withor without bevacizumab 15 mg/kg)

Treatment:

Drug: QL1706