Clinical trial NCT04806945: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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）

Primary outcomes:
measure: Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
timeFrame: up to approximately 1 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: lingying wu
role: PRINCIPAL_INVESTIGATOR
References: