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Official Title: Phase II Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (Saber) for
Metastatic Clear Cell Renal Cell Carcinoma (MRAC)
NCT: 02781506
Document Date: 02/25/2019
Version:
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What is a phase ii trial?
A phase II trial is a clinical research study designed to evaluate the effectiveness and safety of a new drug or treatment in a larger group of patients than phase I trials.
Who is required to file a phase ii trial?
Pharmaceutical companies or researchers conducting the study are required to file a phase II trial with the appropriate regulatory authorities.
How to fill out a phase ii trial?
To fill out a phase II trial, researchers must submit a detailed protocol outlining the study objectives, methodology, patient eligibility criteria, and safety monitoring procedures to the regulatory authority overseeing the trial.
What is the purpose of a phase ii trial?
The purpose of a phase II trial is to further evaluate the safety and effectiveness of a new drug or treatment in a larger group of patients, and to determine the optimal dose and dosing schedule.
What information must be reported on a phase ii trial?
Key information to be reported on a phase II trial includes study objectives, patient inclusion and exclusion criteria, study procedures, dosing regimen, safety monitoring plan, and data analysis plan.
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