Back to resultsA Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HLX10
Paclitaxel
Cisplatin
Carboplatin
Placebo to HLX10
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
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）
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HLX10
Placebo
Arm Description
HLX10 + chemotherapy
Placebo + chemotherapy
Outcomes
Primary Outcome Measures
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
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04806945
Brief Title
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor terminated the trial.
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HLX10
Arm Type
Experimental
Arm Description
HLX10 + chemotherapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + chemotherapy
Intervention Type
Drug
Intervention Name(s)
HLX10
Other Intervention Name(s)
Recombinant humanized anti-PD-1 monoclonal antibody injection
Intervention Description
IV infusion.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo to HLX10
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Description
Baseline until disease progression or death, whichever occurs first
Time Frame
up to approximately 1 years
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cervical cancer only occurs in female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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）
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lingying wu
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
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