A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
NCT ID: NCT04806945
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2022-09-30
2024-10-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HLX10
HLX10 + chemotherapy
HLX10
IV infusion.
Paclitaxel
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Placebo
Placebo + chemotherapy
Paclitaxel
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Placebo to HLX10
IV infusion
Interventions
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HLX10
IV infusion.
Paclitaxel
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Placebo to HLX10
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. CPS≥1
3. Has measurable disease per RECIST 1.1 as assessed by IRRC
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
5. Has adequate organ function
Exclusion Criteria
2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
3. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
4. Has an active infection requiring systemic therapy
5. Has a known history of human immunodeficiency virus (HIV) infection
6. 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）
18 Years
75 Years
FEMALE
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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lingying wu
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Other Identifiers
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HLX10-017-CC301
Identifier Type: -
Identifier Source: org_study_id
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