Overview

A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer

Status:
Not yet recruiting
Trial end date:
2024-10-30
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Henlius Biotech
Treatments:
Carboplatin
Cisplatin
Paclitaxel
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）