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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04806945
• Other study ID #: HLX10-017-CC301
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 30, 2022
• Est. completion date: October 30, 2024

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• HLX10
IV infusion.
• Paclitaxel
IV infusion
• Cisplatin
IV infusion
• Carboplatin
IV infusion
• Placebo to HLX10
IV infusion

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	Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)	Baseline until disease progression or death, whichever occurs first	up to approximately 1 years
Primary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 2 years