Cervical Cancer
Conditions
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).
Interventions
DRUGHLX10
IV infusion.
DRUGPaclitaxel
IV infusion
DRUGCisplatin
IV infusion
DRUGCarboplatin
IV infusion
DRUGPlacebo to HLX10
IV infusion
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) | up to approximately 1 years | Baseline until disease progression or death, whichever occurs first |
| Overall Survival (OS) | Up to approximately 2 years | OS is defined as the time from randomization to death due to any cause. |
Countries
China
Outcome results
None listed