A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of HLX10(Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) plus chemotherapy compared to the efficacy and safety of placebo plus chemotherapy in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin. The primary study hypotheses are that the combination of HLX10 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the IRRC or, 2) Overall Survival (OS).

Official Title
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A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin/Cisplatin and Paclitaxel) vs Chemotherapy (Carboplatin/Cisplatin and Paclitaxel)in Patients With Advanced Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: HLX10
* Drug: Paclitaxel
* Drug: Cisplatin
* Drug: Carboplatin
* Drug: Placebo to HLX10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation) CPS≥1 Has measurable disease per RECIST 1.1 as assessed by IRRC Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization Has adequate organ function Exclusion Criteria: Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has received prior therapy with an anti-PD-1, anti-PD-L1 or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4）

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX10<br>HLX10 + chemotherapy | Drug: HLX10<br>* IV infusion.<br>* Other names: Recombinant humanized anti-PD-1 monoclonal antibody injection;Drug: Paclitaxel<br>* IV infusion<br>Drug: Cisplatin<br>* IV infusion<br>Drug: Carboplatin<br>* IV infusion<br>|
| Placebo Comparator: Placebo<br>Placebo + chemotherapy | Drug: Paclitaxel<br>* IV infusion<br>Drug: Cisplatin<br>* IV infusion<br>Drug: Carboplatin<br>* IV infusion<br>Drug: Placebo to HLX10<br>* IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) | Baseline until disease progression or death, whichever occurs first | up to approximately 1 years | 
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |