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

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04806945
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HLX10

HLX10 + chemotherapy

Drug: HLX10
IV infusion.
Other Names:
  • Recombinant humanized anti-PD-1 monoclonal antibody injection

    • Drug: Paclitaxel
    IV infusion

    Drug: Cisplatin
    IV infusion

    Drug: Carboplatin
    IV infusion
    Placebo Comparator: Placebo

    Placebo + chemotherapy

    Drug: Paclitaxel
    IV infusion

    Drug: Cisplatin
    IV infusion

    Drug: Carboplatin
    IV infusion

    Drug: Placebo to HLX10
    IV infusion

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) [up to approximately 1 years]

      Baseline until disease progression or death, whichever occurs first

    2. Overall Survival (OS) [Up to approximately 2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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）

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital, Chinese Academy of Medical Sciences Beijing China

    Sponsors and Collaborators

    • Shanghai Henlius Biotech

    Investigators

    • Principal Investigator: lingying wu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Henlius Biotech
    ClinicalTrials.gov Identifier:
    NCT04806945
    Other Study ID Numbers:
    • HLX10-017-CC301
    First Posted:
    Mar 19, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Paclitaxel
    Carboplatin

    Study Results

    No Results Posted as of May 5, 2022