A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: QL1706


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL1706 injection<br>The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion | Drug: QL1706<br>* The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC) | The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1 | The ORR assessed by the investigator according to RECIST V1.1 | 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 | 
| The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator | The DOR assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1 | 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 | 
| The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator | The PFS assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1 | 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. | 
| Overall survival | Overall survival | 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. |