A Study of QL1706 in Combination With Chemotherapy With or Without Bevacizumab for Metastatic Cervical Cancer

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05446883
Collaborator
(none)
498
2
23

Study Details

Study Description

Brief Summary

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental:

QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group:

placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS < 1 vs 1 ≤ CPS < 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Study Design

Study Type:
Interventional
Anticipated Enrollment :
498 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study of QL1706 in Combination With Paclitaxel-cisplatin/Carboplatin With or Without Bevacizumab for First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

Drug: QL1706
QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Other Names:
  • paclitaxel
  • cisplatin/carboplatin
  • bevacizumab
  • Placebo Comparator: Treatment B

    Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

    Drug: Placebo
    Placebo (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
    Other Names:
  • paclitaxel
  • cisplatin/carboplatin
  • bevacizumab
  • Outcome Measures

    Primary Outcome Measures

    1. PFS by BICR based on RECIST v1.1 [Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)]

      PFS by BICR based on RECIST v1.1

    2. OS [From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years]

      OS

    Secondary Outcome Measures

    1. PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria [Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months]

      PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The subject fully understood and voluntarily signed the informed consent form.

    • Histologically confirmed cervical cancer.

    • At least one measurable tumor lesion by CT or MRI according to RECIST 1.1 criteria.

    • All subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained FFPE pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    • Expected survival ≥ 12 weeks.

    • Adequate level of vital organ function

    Exclusion Criteria:
    • Previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; previously received VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors.

    • Systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever > 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator)

    • Within two weeks before randomization, there is a need for systemic use of corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) treatment of the disease; Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are permitted for the prevention of contrast allergy。

    • Systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qilu Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qilu Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05446883
    Other Study ID Numbers:
    • QL1706-301
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jun 1, 2022
    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:

    Study Results

    No Results Posted as of Jul 7, 2022