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Showing 1 - 10 of 39 Trials

  • Cyto-KIK TRIAL: CYTO reductive surgery in Kidney cancer plus Immunotherapy (nivolumab) and targeted Kinase inhibition (cabozantinib)

    Principal Investigator:

    Mark N. Stein, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT04322955

    Population:

    Adult

    Phase:

    II
    The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment. The study will also evaluate the changes that nivolumab and cabozantinib cause in the cells adjacent to the tumor in order to understand how the study medicines work and how cancer cells become resistant to these medicines. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have...

  • A Phase 1, Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®819 in Subjects with Relapsed or Refractory Clear Cell Renal Cell Carcinoma

    Principal Investigator:

    Karie Danielle Keera Runcie, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT05433142

    Population:

    Adult

    Phase:

    I
    The purpose of this study is to assess whether an investigational drug called XmAb819 has any effects on Clear Cell Renal Cell Carcinoma, to determine if it is safe and well tolerated, and to determine the dosing schedule. The investigational drug will be given by intravenous (IV – into the vein) infusion over a 2 hour period. This study will also see how the body affects the study drug and how much study drug is in the blood (pharmacokinetics, or “PK”), how the drug affects the tumor and body (pharmacodynamics, or “PD”), and if the body develops antibodies...

  • A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients with Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

    Principal Investigator:

    Karie Danielle Keera Runcie, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT04028245

    Population:

    Adult

    Phase:

    I
    The purpose of this study is to study two experimental drugs called canakinumab and spartalizumab produced by Novartis to see if: • It is safe and feasible to give canakinumab and spartalizumab prior to radical nephrectomy? • Canakinumab and spartalizumab can kill cancer cells and bring immune cells into the kidney cancer when hen given to human subjects prior to radical nephrectomy? You are being asked to participate in this study because you have localized kidney cancer and you are planned to have a radical nephrectomy. People who usually have this do not receive any additional...

  • Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (ARCITECT)

    Principal Investigator:

    Karie Danielle Keera Runcie, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT05928806

    Population:

    Adult

    Phase:

    II
    The purpose of this study is to find out if the combination of botensilimab and balstilimab is more effective and safer at treating in clear cell Renal Cell Cancer (ccRCC) [kidney cancer] that has spread to other parts of the body (metastatic) than the standard combination of nivolumab and ipilimumab. The combination of nivolumab and ipilimumab has already been approved by the Food and Drug Administration (FDA) for use in advanced kidney cancer. The combination of balstilimab and botensilimab is investigational and has not been approved by the Food and Drug Administration (FDA). Are you...

  • EXACT: Randomized phase II trial of XL092 in combination with immunotherapy in patients who progress on Adjuvant therapy in Clear Cell RCC

    Principal Investigator:

    Karie Danielle Keera Runcie, MD

    Contact Number:

    212-342-5162

    Population:

    Adult

    Phase:

    II
    The purpose of this study is to see if study drug XL092 alone or in combination with nivolumab can treat your cancer after your cancer has progressed on adjuvant treatment. Researchers also want to look at the safety of the XL092 alone and in combination with nivolumab. We are asking you to take part in this research study because you have clear cell renal cell carcinoma (clear cell kidney cancer), and your disease has come back after adjuvant treatment (treatment given after your disease progresses from your first treatment). - XL092 is not approved by the U.S. Food and Drug Administration (...

  • A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

    Principal Investigator:

    Mark N. Stein, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT03866382

    Population:

    Adult

    Phase:

    II
    This purpose of this study is to test the effectiveness of cabozantinib with nivolumab and ipilimumab in rare genitourinary cancers that have no standard treatment options. Are you Eligible? (Inclusion Criteria) Do you have confirmed diagnosis of one of the following cancers? -small cell carcinoma of the bladder; -adenocarcinoma of the bladder; -squamous cell carcinoma of the bladder; -plasmacytoid urothelial carcinoma; -any penile cancer; -sarcomatoid renal cell carcinoma; -sarcomatoid urothelial carcinoma; -renal medullary carcinoma or other miscellaneous histologic variants of the...

  • AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

    Principal Investigator:

    Nobuko Hijiya, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT04322318

    Population:

    Pediatrics/Adult

    Phase:

    II
    This is a Phase 2 study of patients for the treatment of patients with high risk Wilms tumors (including those with diffuse anaplastic Wilms tumor- DAWT) and those who have relapsed favorable histology Wilms tumor (FHWT). The main goal of the study is to find out whether treatment with chemotherapy consisting of vincristine/irinotecan; cyclophosphamide/carboplatin/etoposide; and vincristine/doxorubicin/cyclophosphamide) improves the survival of patients with newly diagnosed Stage 4 diffuse anaplastic Wilms tumor (DAWT) or Standard-Risk relapsed favorable histology Wilms tumor (SRrFHWT) as...

  • A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors

    Principal Investigator:

    Benjamin Izar, MD, PhD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT05098132

    Population:

    Adult

    Phase:

    I
    The main purpose of this study is to determine the highest dose of STK-012 that can be given safely alone and in combination with a standard dose of pembrolizumab in subjects with advanced solid tumors, this will be assessed in the dose escalation phase of the study. In the dose expansion phase of the study, the highest dose of STK-012 that can be safely given in combination with pembrolizumab, as determined in the dose escalation phase, will be given to more people for further study.STK-012 is a modified (changed in the laboratory) form of a cytokine (protein) called interleukin-2 (IL-2)...

  • A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors

    Principal Investigator:

    Karie Danielle Keera Runcie, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT05176483

    Population:

    Adult

    Phase:

    I
    The purpose of this study is to evaluate the efficacy of the study drug, XL092 alone and/or in combination of other study drugs such as with nivolumab, nivolumab plus ipilimumab, or nivolumab/relatlimab fixed dose combination as a potential anticancer therapy to treat people with locally advanced or metastatic cancers including advanced renal cell cancer, castration-resistant prostate cancer, bladder cancer, liver cancer, lung cancer, colon cancer, head and neck cancer. Nivolumab has been approved as single agent for the treatment of melanoma, lung cancer, and bladder cancer and in...

  • A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

    Principal Investigator:

    Benjamin Izar, MD, PhD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT04262466

    Population:

    Adult

    Phase:

    I/II
    This is a research study to determine how safe and effective a new treatment, called IMC-F106C, is for treating advanced cancers. This study is the first time the study drug is being tested in people. IMC-F106C has been developed to treat cancer by activating the body’s own immune system to fight the tumor. The study drug has 2 parts. The first part, called a “T cell receptor”, sticks very tightly to tumor cells that make markers called “HLA-A*02:01” and “PRAME”. The second part, called “anti-CD3 scFv”, sticks to a T cell (a type of white...

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