- 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)
3rd 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]
Cervical Cancer
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