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  • Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

    Phase

    3

    Span

    387 weeks

    Sponsor

    GlaxoSmithKline

    Sao Jose do Rio Preto

    Recruiting

  • A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

    This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever. Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK [cohort 1] and sparse PK sampling [cohort 2]).

    Phase

    2

    Span

    106 weeks

    Sponsor

    Novartis Pharmaceuticals

    Sao Jose do Rio Preto

    Recruiting

  • Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

    The primary endpoint of interest in this study is time to next treatment (TTNT), a measure that will determine how long T-DXd allows patients to derive clinical benefit from the study drug.

    Phase

    3

    Span

    196 weeks

    Sponsor

    Daiichi Sankyo

    Sao Jose do Rio Preto

    Recruiting

  • Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

    Phase

    2

    Span

    256 weeks

    Sponsor

    Sanofi

    Sao Jose do Rio Preto, São Paulo

    Recruiting

  • Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

    Phase

    3

    Span

    468 weeks

    Sponsor

    Regeneron Pharmaceuticals

    Sao Jose do Rio Preto

    Recruiting

  • A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

    This is an open-label, non-randomized, multicenter roll-over extension program (REP) to: - CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and - CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN. Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until: - 3 years from LPFV of this study CLNP023A2002B, or - the participant no longer derives benefit from iptacopan according to the Investigator, or - the benefit-risk profile of the product in IgAN is no longer positive, or - initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or - the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or - if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner

    Phase

    3

    Span

    582 weeks

    Sponsor

    Novartis Pharmaceuticals

    Sao Jose do Rio Preto

    Recruiting

  • Feasibility Study of Intermediate Doses of ARA-C With Autologous SCT as Consolidation of Low/Intermediate-risk AML

    1. Compare overall survival and disease-free survival of patients with acute myeloid leukemia classified according the European LeukemiaNet treated in participating South American hospitals with the results reported in developed countries. 2. Compare overall survival and disease-free survival of patients with AML low or intermediate risk treated with two cycles of cytarabine in intermediate dose versus one cytarabine cycle at the same dose followed by autologous SCT as consolidation. The risk will be established according to the classification of the European LeukemiaNet. 3. Create a network of institutions in developing countries that will perform AML diagnosis, risk classification, treatment, supportive care and follow-up evaluation according to a common protocol and will register data using common clinical research forms (CRFs) in a single database and available on the internet 4. Using National Reference Laboratories, provide cytogenetic and molecular methods for all institutions participating in the network, thus allowing rapid diagnosis and risk stratification of AML cases according to the European LeukemiaNet structure; 5. Develop a method of assessing minimal residual disease based on flow cytometry adapted to local resources and capable of guiding therapeutic decisions; 6. Determine the time interval between: a) diagnosis and risk group determination; b) the first cycle of consolidation chemotherapy and autologous hematopoietic stem cells infusion; 7. Determine the frequency and etiologic agent of infections associated with treatment, the number and average duration of hospitalization due to episodes of neutropenia; 8. Create a bank of samples of bone marrow from AML patients at different times of treatment; 9. Determine the disease-free survival and the cumulative incidence rate of relapse and non-relapse mortality and compare them between chemotherapy alone and chemotherapy plus autologous SCT cohorts.

    Phase

    N/A

    Span

    270 weeks

    Sponsor

    International Consortium on Acute Leukemias

    Sao Jose do Rio Preto, São Paulo

    Recruiting

  • Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

    The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.

    Phase

    2/3

    Span

    452 weeks

    Sponsor

    Janssen Research & Development, LLC

    Sao Jose do Rio Preto

    Recruiting

  • A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

    Up to 5 years

    Phase

    3

    Span

    245 weeks

    Sponsor

    Sanofi

    Sao Jose do Rio Preto, São Paulo

    Recruiting

  • A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

    Phase

    3

    Span

    227 weeks

    Sponsor

    Janssen Research & Development, LLC

    Sao Jose do Rio Preto

    Recruiting

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