A Single-Arm, Open-Label, Multicentre, Phase II Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy

Shanghai Henlius Biotech1 site in 1 country21 target enrollmentMarch 10, 2020

ConditionsCervical Cancer

InterventionsHLX10+Albumin-Bound Paclitaxel

DrugsHLX10+Albumin-Bound Paclitaxel

Overview

Phase: Phase 2
Intervention: HLX10+Albumin-Bound Paclitaxel
Conditions: Cervical Cancer
Sponsor: Shanghai Henlius Biotech
Enrollment: 21
Locations: 1
Primary Endpoint: ORR
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, multicentre, phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.All enrolled patients will receive the treatment with HLX10 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and HLX10 for up to 2 years.

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

September 15, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participate and have signed the informed consent form (ICF);
•Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF
•Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
•Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. First-line chemotherapy includes any of the following:
•Platinum-based drugs + taxanes;
•Platinum-based drugs + topotecan;
•Taxanes + topotecan.
•The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).
•Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1).
•An ECOG score of 0 or

Exclusion Criteria

•Patients who have previously received albumin-bound paclitaxel.
•Patients with other active malignancies within 5 years or at the same time.
•Patients who are preparing for or have received an organ or bone marrow transplant.
•Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
•Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.
•Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) \< 50% by cardiac colour Doppler.
•8.With human immunodeficiency virus (HIV) infection. 9.With active pulmonary tuberculosis. 10.Have received any T-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.

Arms & Interventions

HLX10

HLX10+albumin-bound paclitaxel

Intervention: HLX10+Albumin-Bound Paclitaxel

Outcomes

Primary Outcomes

ORR

Time Frame: up to 2 years

Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

Secondary Outcomes

6-month PFS rate(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months)
ORR(up to 2 years)
PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years)
OS(from the date of first dose until the date of death from any cause，assessed up to 2 years)
6-month OS rate(from the date of first dose until the date of 6-month)