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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04806945
Other study ID # HLX10-017-CC301
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date September 30, 2022
Est. completion date October 30, 2024

Study information

Verified date March 2021
Source Shanghai Henlius Biotech
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 30, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. 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) 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: 1. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HLX10
IV infusion.
Paclitaxel
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Placebo to HLX10
IV infusion

Locations

Country Name City State
China Cancer Hospital, Chinese Academy of Medical Sciences Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Overall Survival (OS) OS is defined as the time from randomization to death due to any cause. Up to approximately 2 years
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