Clinical trial NCT05557565: A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
Official title: A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.

Detailed description: This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.

The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.

Eligibility criteria: Inclusion Criteria:

* The subject will participate voluntarily and sign the informed consent form.
* Female, aged ≥18 years when signing the informed consent form.
* Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
* At least one measurable lesion is needed.
* The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
* Adequate reserves of organ function is needed.

Exclusion Criteria:

* Active autoimmune disease.
* Central nervous system (CNS) metastasis.
* Concomitant diseases such as cardiovascular and cerebrovascular diseases.
* Fistula of female genital tract.
* Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
* Previous recipients of immune checkpoint inhibitors.
* Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug.
* Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug.
* History of immunodeficiency.
* History of allogeneic hematopoietic stem cell transplantation or organ transplantation.

Primary outcomes:
measure: The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
timeFrame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
Secondary outcomes:
measure: The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1
timeFrame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
measure: The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator
timeFrame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
measure: The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.
measure: Overall survival
timeFrame: From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: