Ask a Scientist About Cancer Immunotherapy Clinical Trials

Each week in June 2017, as part of Cancer Immunotherapy Month, we published a response to patient questions from immunotherapy expert Dr. Michael Postow of Memorial Sloan Kettering Cancer Center. This series is made possible with generous support from Regeneron.

June 1

How is treatment on a clinical trial different from my regular treatment?

Clinical trials are different from regular cancer treatment. Clinical trials often test (a) drugs that are not yet approved by the FDA, (b) different combinations of drugs some of which might have already been approved by the FDA, or (c) existing FDA-approved drugs given in different schedules or different doses. Clinical trials test new ways that we hope and expect are better than conventional approaches. Some of the most promising treatments have been started in clinical trials. It's important for patients to understand how much is known so far and ask: What are the benefits? What are the potential risks? How does this compare to a standard approach?

June 8

Will I feel like a guinea pig in a clinical trial?

It's a common fear to think "Will I feel like a guinea pig if I participate in a clinical trial?" It's incumbent upon the doctors and treatment teams to make patients comfortable when they embark on a clinical trial. A doctor conducting a clinical trial doesn't want any patient to feel like a guinea pig. The goal of the trial is to try to help the patient and give them access to something that may not otherwise be available. It's important that patients feel comfortable participating. Patients should ask questions and advocate for themselves. Most patients in trials do not feel like a guinea pig.

June 12

Can I be sure I'll get treatment and not just placebo in a clinical trial?

A placebo is a type of treatment that is not an active drug, and it is very rare for a clinical trial to have a placebo. Almost all clinical trials are testing some form of active treatment, such as a new drug against standard of care or a new combination of drugs against standard of care. Patients and doctors should discuss whether a trial contains a placebo, the role it plays in the trial, and the pros and cons of trials that include a placebo.

June 19

How are phase 1, 2, and 3 clinical trials different?

The goal of each phase of clinical trials is different. A phase 1 trial is the first time something is being done for a patient, such as the first time a drug or drug combination is given to patients. Phase 2 trials test how effective something is in a group of patients. Phase 3 trials ask the question is a new approach better than a standard of care approach. Sometimes trial phases may blend together in modulated or combined phase trials. Discuss the pros and cons of different phase trials and the possibility of modulated or combined phase trials with your care team.

June 26

How can I find a clinical trial?

Finding clinical trials is one of the most important things that patients and their care teams can do as part of the care continuum. There are many ways to find a trial. Advocate for yourself and discuss it with your oncologist or oncology nurse. If you're near a large research center or academic institution, your care team can think about what trials may be right for you. If you're at a smaller practice, ask your oncologist or oncology nurse if it is worth a referral to one of the large research centers. Referrals are not always necessary for clinical trials. You can also find clinial trial access programs at advocacy and resource organizations, such as the Cancer Research Institute Immunotherapy Clinical Trial Finder. The clinical trial world is complex and it's important to talk about an individual situation in detail for what's appropriate.