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Centro De Desarrollo De Proyectos Avanzados Roma 1465, Cordoba,, Argentina

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  • A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

    This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

    Phase

    3

    Span

    295 weeks

    Sponsor

    AstraZeneca

    Cordoba

    Recruiting

  • A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

    The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide. In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).

    Phase

    3

    Span

    202 weeks

    Sponsor

    Celgene

    Cordoba

    Recruiting

  • An Ophthalmic Safety Study in Patients With Breast Cancer

    This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.

    Phase

    N/A

    Span

    122 weeks

    Sponsor

    AstraZeneca

    Cordoba

    Recruiting

  • A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma

    Phase

    3

    Span

    401 weeks

    Sponsor

    BeiGene

    Cordoba

    Recruiting

  • A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

    The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

    Phase

    3

    Span

    268 weeks

    Sponsor

    AstraZeneca

    Cordoba

    Recruiting

  • A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

    Phase

    3

    Span

    151 weeks

    Sponsor

    Takeda

    Cordoba

    Recruiting

  • Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

    Phase

    3

    Span

    249 weeks

    Sponsor

    AstraZeneca

    Cordoba

    Recruiting

  • Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

    Phase

    3

    Span

    317 weeks

    Sponsor

    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Cordoba

    Recruiting

  • A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations

    This trial will evaluate the safety and efficacy of valemetostat tosylate (DS-3201b) in combination with fixed-dose pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic NSCLC without actionable genomic alterations, whose tumor has PD-L1 TPS ≥50%, and who have not received prior systemic therapy for advanced or metastatic NSCLC. The trial will be in 2 phases, dose escalation and dose expansion phases.

    Phase

    1/2

    Span

    287 weeks

    Sponsor

    Daiichi Sankyo

    Cordoba

    Recruiting

  • A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

    Phase

    3

    Span

    693 weeks

    Sponsor

    Merck Sharp & Dohme LLC

    Cordoba

    Recruiting

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