FAQs for Immunotherapy Clinical Trials

A clinical trial is a study designed to evaluate a promising new medical treatment for you. We evaluate new ways to prevent, diagnose, and/or treat cancer and up to 50 percent of our patients are eligible to enter clinical trials.

A clinical trial is like a test or a study. The study progresses in an orderly series of steps, called phases. This allows our researchers to ask and answer questions in a way that gives reliable results about the drug or therapy while still protecting you. Clinical trials are usually classified in three phases — I, II, III.

Phase I trials are the first step in showing people can safely use a new drug or treatment. Our researchers collect information on what dose works best and how the drug or therapy should be given – whether it is given by mouth, injected into a vein or injected into the muscle. Our researchers work closely with the research coordinator and clinical team to look for any side effects. Phase I trials usually enroll a small number of patients. The patients are divided into small groups, called cohorts. Each cohort is treated with an increased dose of the new treatment or technique. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing.

Phase II trials study the safety and effectiveness of a drug or therapy, and evaluate how it affects your body. Phase II studies usually focus on a particular type of cancer, and include fewer than 100 patients.

Phase III trials compare a new drug or therapy, or a new use of a standard drug or therapy, with the currently accepted and most widely used treatment for a certain type of cancer. Participants are randomly assigned to the standard group or the new group, usually by a computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study’s results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials may include hundreds of people across the country.

In order to advance cancer treatment, new drugs and therapies are being created every day. Clinical trials ensure:

  • Top physicians in the field of cancer research are advancing treatments.
  • Patients have access to new drugs and treatment methods before they are widely available.
  • Your health is being closely monitored for any side effects.
  • You have a more active role in your own health care.
  • You have options beyond the standard cancer treatments.

As with anything new, new drugs and procedures may have side effects or risks unknown to the doctors. Another risk is that the treatment may not be effective or the benefits may not work for you.

Each study’s protocol is different. We create guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history and current health status. Eligibility criteria for treatment studies often require patients have a particular type and stage of cancer.