A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04150575
• Other study ID #: HLX10-011-CC201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 10, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: October 2021
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: September 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Voluntarily participate and have signed the informed consent form (ICF);

2. Aged = 18 years and = 75 years at the time of signing the ICF

3. Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).

4. 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:

1. Platinum-based drugs + taxanes;

2. Platinum-based drugs + topotecan;

3. Taxanes + topotecan.

5. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).

6. Patients whose tumour specimens are tested positive for PD-L1 expression (CPS = 1).

7. An ECOG score of 0 or 1.

8. Conforming to laboratory measurements;

Exclusion Criteria:

1. Patients who have previously received albumin-bound paclitaxel.

2. Patients with other active malignancies within 5 years or at the same time.

3. Patients who are preparing for or have received an organ or bone marrow transplant.

4. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

5. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.

6. 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Disease Progression
• Uterine Cervical Neoplasms

Intervention

Drug:
• HLX10+Albumin-Bound Paclitaxel
HLX10: 4.5 mg/kg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and HLX10 for up to 2 years.

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	ORR	Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)	up to 2 years
Secondary	ORR	Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively)	up to 2 years
Secondary	PFS	Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively)	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary	6-month PFS rate	6-month progression-free survival rate	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months
Secondary	OS	Overall survival	from the date of first dose until the date of death from any cause,assessed up to 2 years
Secondary	6-month OS rate	6-month overall survival rate	from the date of first dose until the date of 6-month

External Links

•   Efficacy and safety evaluation of HLX10 combined with nab-paclitaxel in patients with CC who have progressive disease after 1L standard