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

NCT04806945 | Withdrawn Phase 3 DMC

• 1 other identifier: HLX10-017-CC301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Overall Survival (OS)

  OS is defined as the time from randomization to death due to any cause.

  Up to approximately 2 years

Study Arms (2)

HLX10

EXPERIMENTAL

HLX10 + chemotherapy

Drug: HLX10; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin

Placebo

PLACEBO COMPARATOR

Placebo + chemotherapy

Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Placebo to HLX10

Interventions

HLX10 DRUG

IV infusion.

Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection

HLX10

Paclitaxel DRUG

IV infusion

HLX10; Placebo

Cisplatin DRUG

IV infusion

HLX10; Placebo

Carboplatin DRUG

IV infusion

HLX10; Placebo

Placebo to HLX10 DRUG

IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Cervical cancer only occurs in female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• CPS≥1
• Has measurable disease per RECIST 1.1 as assessed by IRRC
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
• Has adequate organ function

You may not qualify if:

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• 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）

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• lingying wu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: September 30, 2022
• Primary Completion: February 15, 2024
• Study Completion: October 30, 2024
• Last Updated: May 5, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)