Flora Zagouri

Κλινικές Μελέτες

Περισσότερες από 60 διεθνείς πολυκεντρικές κλινικές μελέτες

  • evERA: A phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant plus everolimus compared with exemestane plus everolimus in patients with estrogen receptor-positive, HER2- negative, locally advanced or metastatic breast cancer
  • ASCENT 07: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
  • VIKTORIA-1: A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy
  • Veritac-2: A Phase 3, Randomized, Open-label, Multicenter Trial of ARV-471 (PF-07850327) vs Fulvestrant in Participants with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment for Advanced Disease
  • HER2CLIMB-05: A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer
  • ASTEFANIA: A phase III, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine for HER2-positive breast cancer at high risk of recurrence following preoperative therapy
  • TROPION-Breast03: Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy 
  • EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
  • LidERA: A phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with physician’s choice of adjuvant endocrine monotherapy in patients with estrogen receptor-positive, HER2‑negative early breast cancer
  • KEYNOTE-B49: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer
  • The real-world Hellenic disease management patterns with everolimus (EVE) for women with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer (aBC): ‘The MIRROR’ study
  • MonarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care Chemotherapy of Physician’s Choice plus Trastuzumab in Women with HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
  • eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy (jpcw)
  • monarchE: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
  • DS8201-A-U301: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator’s Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1.

 

  • DS8201-A-U303: A Phase 3, multicenter, randomized, open-label, active-controlled trial of DS-8201a, an anti-HER2-antibody drug conjugate (ADC), versus treatment of physician’s choice for HER2-low, unresectable and/or metastatic breast cancer subjects
  • DS8201-A-U305: Phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in subjects with high-risk HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy
  • Xenera: Multi-centre,Double blind, placebo controlled, randomized phase II trial to compare efficacy of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in women with HR+/HER2- metastatic breast cancer and non-visceral disease.
  • PIK3CA Registry A descriptive study of PIK3CA mutations in patients with HR+/Her2-advanced breast cancer
  • CAPITELLO-290: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC)
  • KATE3: A Randomized, Multicenter, Doubleblind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination with Atezolizumab or Placebo in Patients with HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab(+/- Pertuzumab) and Taxane-Based Therapy
  • togetHER Study: A Hellenic Retrospective Chart Review Study to Characterize the Patient Profile and to Capture the Real-World Management Strategies and thei Outcomes in the Second-Line Setting and Beyond of Metastatic HER2-Positive Breast Cancer
  • EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator’s Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
  • sHERLoc: A Non-Interventional Epidemiological Study to Retrospectively Capture the Frequency of HER2-Low Expression in HR+ Metastatic Breast Cancer (MBC) and to Prospectively Observe the Real-World Effectiveness Outcomes in HR+ HER2-Low MBC Patients treated with Available Treatment Options in the First- as well as in the Second- and Third-Line Setting Post-Endocrine Therapy in Greece
  • postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
  • TRINITY Study: A retrospective, multicenter, observational study to understand treatment patterns and use of Neoadjuvant Systemic Treatment (NST) for the management of early / locally advanced (stage II-III) Triple Negative Breast Cancer (TNBC) in Greece
  • KEYNOTE-A18: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer
  • An Open-Label Randomized Phase 3 Clinical Trial of REGN2810 Versus Therapy of Investigator’s Choice Chemotherapy in Recurrent or Metastatic Platinum-Refractory Cervical Carcinoma
  • A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy with TSR-O42 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
  • ATHENA: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment FollowingResponse to Front-Line Platinum-Based Chemotherapy
  • AXLerate-OC: A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB S6 500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer
  • XPORT-EC-042: A phase 3, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced or recurrent endometrial carcinoma
  • KEYNOTE-B21: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent
  • DUO E: A Randomized, Multi-Center, Double Blind, Placebo controlled, Phase III Study of first-line Carboplatin and Paclitaxel in combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in patients with newly diagnosed Advanced or recurrent Endometrial Cancer
  • PODIUM-204: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy
  • SIENDO: A randomized, double-blind, phase 3 trial of maintenance with selinexor/placebo after combination chemotherapy for patients with advanced or recurrent endometrial cancer
  • XL092-304: A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma 
  • MK-6842-011: An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
  • MK6482-013: Phase 2 Study of MK-6482 in Participants with Advanced Renal Cell Carcinoma
  • MK-6482-022: A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy
  • CONTACT 03: A Phase III, multicenter, randomized, open-label study to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in patients with inoperable, locally advanced, or metastatic renal cell carcinoma who experienced radiographic tumor progression during or after immune checkpoint inhibitor treatment
  • AVION: Real-world evaluation of efficacy and safety with AVelumab (BAVENCIO) + Axitinib (INLYTA) in patients with Advanced Renal-Cell CarcinOma (RCC) in multiple EU countries
  • RIO study: Study of real-world treatment patterns and health care costs in patients with Renal-cell carcinoma treated with IO-based first line regimens
  • CLIN-60000-452: A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
  • BO42843: A phase III, double-blind, multicenter, randomized study of atezolizumab (anti-pd-l1 antibody) versus placebo as adjuvant therapy in patients with high-risk muscle-invasive bladder cancer who are ctDNA positive following cystectomy
  • BO44157: A phase II, randomized, multicenter, open-label, controlled study of RO 7247669 alone or in combination with tiragolumab versus atezolizumab in patients with previously untreated locally advanced or metastatic urothelial bladder cancer who are ineligible for platinum-containing chemotherapy
  • JAVELIN Bladder Medley: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy
  • KEYNOTE-B15: A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer
  • VOLGA: A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer
  • IMMU-132-13: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer
  • HLX10-020-SCLC302: A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC)
  • GFH925X0201: A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
  • BGBC016: Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation
  • COSTAR Lung: A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy
  • KEYVIBE-006: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC
  • 213824: A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer
  • ZEAL-1L: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer
  • HE1/17 – PAVE: Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer (SCLC)
  • Real-World Treatment Patterns, Clinical Outcomes, and EGFR / T790M Testing Practices in EGFR-Mutated Advanced Non-Small Cell Lung Cancer Patients Receiving First-Line EGFR TKI Therapy (REFLECT)
  • ARC-10: A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined with Domvanalimab (AB154) Compared to Pembrolizumab in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
  • INFINITY Study: A nationwide retrospective observational study to record patIent characteristics and treatmeNt patterns in a representative sample oF patients with earlIer stages of Non-Small Cell Lung Cancer (NSCLC), as well as to capture the dIstribuTion of disease stages and the sYstemic treatment rate among patients diagnosed with NSCLC of any stage during the period 2016-2020 in Greece.
  • AURORA study: A non-interventional, multicenter, prospective study to record treatment patterns of nivolumab+ipilimumab+chemotherapy combination as first line treatment of metastatic NSCLC in routine clinical practice in Greece – the ‘AURORA’ study
  • AZUR: A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
  • MK-1308A-008: A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated quavonlimab (MK-1308)/pembrolizumab) Versus Other Treatments in Participants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer
  • POWER: Real World Data of 1st line Panitumumam Treatment in Combination With Chemotherapy in non Resectable Wild Type (WT) RAS Metastatic Colorectal Cancer (mCRC) Subjects in Austria, Bulgaria, Croatia, Czech Republic, Greece, Hungary, Poland, Slovenia, Romania, Russia an Observational Ambidirectional Study
  • A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy
  • HE3/16 -RACING: RAmucirumab Combined wIth standard Nab-paclitaxel and Gemcitabine as first –line chemotherapy in patients with advanced pancreatic adenocarcinoma
  • LIBRETTO-531: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer
  • PROSPECT study: Study of real-world treatment patterns and health care costs in patients with metastatic castration-resistant prostate cancer

Λοιπές κλινικές μελέτες

  • SKYSCRAPER-11: A Phase II, Single-Arm, Open-Label Study Evaluating the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
  • WAYFIND-R: A registry to collect characteristics and outcomes from patients with solid tumors profiled with a next-generation sequencing test
  • API-CAT: Long-term treatment of cancer associated VTE: reduced vs full dose of apixaban: API-CAT STUDY for APIxaban Cancer Associated Thrombosis
  • VicToRiA study: Real World data on VTE treatment in Greece (Venous Thromboembolism Real- VicToRiA study)
  • CA209-8TT: Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab
  • NAVIGATE: A Phase 2 Basket Study of the Oral TRK Inhibitor larotrectinib in Subjects with NTRK-Fusion Positive Tumors
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