^
    Back
    Association details:
    Biomarker:PD-L1 expression
    Cancer:Cervical Cancer
    Drug:Yutuo (zimberelimab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    PRNewswire
    Title:

    Gloria Biosciences Announces Zimberelimab Approved in China for the Treatment of Recurrent or Metastatic Cervical Cancer

    Published date:
    09/06/2023
    Excerpt:
    Guangzhou Gloria Biosciences...announced that its fully human anti-PD-1 monoclonal antibody, Zimberelimab injection (YuTuo, GLS-010) has received marketing approval from the China National Medical Products Administration (NMPA), as monotherapy for the treatment of recurrent or metastatic cervical cancer (R/M CC) patients with positive PD-L1 expression (CPS≥1) who progressed on or after platinum-based chemotherapy.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

    Excerpt:
    ...Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1),.The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    An open, multi-center, single-arm phase II clinical study for evaluating the efficacy and safety of recombinant fully human anti-PD-1 monoclonal antibody (GLS-010 injection) in patients with recurrent or metastatic cervical cancer

    Excerpt:
    ...Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1); 4. ...
    Trial ID:
    ChiCTR1900023529
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC

    Excerpt:
    ...Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection; 9....
    Trial ID:
    NCT06055738
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer

    Excerpt:
    ...- Before enrollment, try to provide enough tumor tissue samples (archived or fresh biopsy samples) to evaluate and confirm the expression of PD-L1 and to detect other biomarkers; Considering the accessibility of clinical specimens, there is...
    Trial ID:
    NCT05437692
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Study of GLS-010 Injection in Patients With Recurrent or Metastatic Cervical Cancer

    Excerpt:
    ...Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1)....
    Trial ID:
    NCT03972722
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2020
    Title:

    Gls-010, a novel anti-PD-1 mAb in Chinese patients with recurrent or metastatic cervical cancer: Results from a multicenter, open-label and single-arm phase II trial.

    Published date:
    05/13/2020
    Excerpt:
    With a median follow-up of 2.9 months, 7 of 25 evaluable pts achieved a partial response (PR). The ORR was 28% (95% CI, 12.07-49.39), with 7 pts achieving a PR ( 3 of 7 confirmed), 3 pts achieving stable disease (SD) and 15 pts with progressive disease (PD)...
    DOI:
    10.1200/JCO.2020.38.15_suppl.6039
    Trial ID:
    NCT03972722