Cervical Cancer

  • CX5  Low-risk Early Stage Cervical Cancer (SHAPE) - Radical Vs Simple Hysterectomy and Pelvic Node Dissection, 1st Line
    Study Design: Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection 
    Main Inclusion Criteria: 
    •    Low-risk early stage cervical cancer
    •    Histologies: adenocarcinoma, squamous or adenosquamous carcinoma
         o    Diagnosis:  LEEP, cone or cervical biopsy
         o    Reviewed and confirmed by the gynecological pathologist
    •    Surgery to be done within 20 weeks of initial diagnosis
    Main Exclusion Criteria: 
    •    FIGO 1A1 disease [FIGO Annual Report, 2009]
    •    Lymph node metastasis on preoperative imaging or histology
    •    Neoadjuvant chemotherapy
     [Details]
     
  • REGN2810 Recurrent or Metastatic Platinum-Refractory Cervical Cancer - (cemiplimab)
    3th Line:  Immunotherapy or Chemotherapy
    Study Drug:
    REGN2810 (cemiplimab); Chemotherapy: Pemetrexed or Topotecan or Irinotecan or Gemcitabine or Vinorelbine
    Main Inclusion Criteria: 
    •    Recurrent, persistent, and/or metastatic cervical cancer
    •    Histologies: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
    •    Tumor progression or recurrence within 6 months of last dose of platinum therapy
    •    Received prior bevacizumab and paclitaxel therapy OR had clinically documented reason why not administered
    Main Exclusion Criteria: 
    •    Sarcomas and neuro-endocrine carcinomas 
    •    Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
    [ Details]
     
  • CR1525MK Advance Solid Tumor:  Pembrolizumab, 2nd Line
    Study drug:
    Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
    Main Inclusion criteria:
    •    Any advanced solid tumor which is Microsatellite Instability (MSI)-High (MSI-H)
    •    There is no limit to the number of prior treatment regimens
    •    Can supply tumor tissue for study analyses 
    Main Exclusion criteria:
    •    Active autoimmune disease that has required systemic treatment in the past 2 years
    •    Previously participated in any other pembrolizumab (MK-3475) study, or received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1), anti-PD-L2
     [Details]
     
  • CA209-484 Solid Tumors of High Tumor Mutational Burden (TMB-H)  Nivolumab +/- Ipilimumab
    Main Inclusion Criteria:
    •    Solid malignant tumor with TMB-H 
    •    Available tumor tissue and blood for TMB testing 
    •    Measurable disease 
    Main Exclusion Criteria:
    •    Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
     [Details]
     
  • CAPTUR (Canadian Profiling and Targeted Agent Utilization Trial)
    Study Drug:
    targeted therapies
    Main Inclusion Criteria: (screening step - non-drug specific)
    •    Tumour genomic or protein expression testing 
    •    Patients must have measurable disease
    •    ECOG performance status 0-2.
    Main Exclusion Criteria:
    •    Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician
     [Details]

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