Should You Participate?

Clinical trial enrollment can be an important option for patients with cancer. For some patients, taking part in a clinical trial may be the best treatment choice. By participating in clinical trials, patients are also helping to advance new knowledge and treatments that will help future generations.

Here are some things that you may find helpful if you are considering enrolling in a cancer immunotherapy clinical trial.

How will an immunotherapy clinical trial enrollment be different?

Because of the unique properties and potential of cancer immunotherapies, clinical trials of these treatments may offer promising alternatives to other kinds of therapeutic approaches.

Cancer immunotherapy is generally very safe and does not come with the same side effects as conventional chemotherapies.
Immunotherapy can complement or synergize with other treatments, potentially increasing the chances of success, often with minimal or no additional toxicity.
Immunotherapy has already succeeded in making some ‘incurable’ cancers curable, and holds the potential to fundamentally change the way that all cancers are treated.

What should I look for?

The following are some of CRI’s recommendations when evaluating clinical trial enrollment of investigational cancer immunotherapies. For help on interpreting information found in clinical trial records, go to https://clinicaltrials.gov/ct2/help/how-read-study.

Although you are guaranteed to receive experimental treatment in phase I trials, the agents being tested in these trials have not been fully evaluated for safety, and you may not receive the optimal dose. In randomized, later-phase (phase II and III) trials, the safety of the treatment has been established, and it may have shown signs of clinical efficacy. In randomized trials, however, you are not guaranteed to receive the treatment under investigation.
Although immunotherapies have the potential to offer safer, less toxic treatment options, they are not without risk. Side effects can include immune-related adverse events, from minor inflammation-related symptoms, such as fever, to major conditions similar to autoimmune disorders, or even death.
Because most immunotherapies are still in the experimental phase (i.e., have not been definitively proven to show improvement over the current standard of care), there is an ethical and legal requirement to treat patients first with the current standard of care, often a combination of surgery, radiation, and chemotherapy. Many trials are open only to patients who have undergone these treatments. Sometimes, an experimental immunotherapy might be administered concurrently with the standard of care.
There is still much we don’t know about how the immune system responds to immunotherapy, and how these responses correlate with clinical benefits. Therefore, many clinical trials of cancer immunotherapies include correlative studies. These are laboratory studies that help us understand exactly how the treatment is working on the immune system. Because of these studies, cancer immunotherapy clinical trials may require more visits over a longer period of time, as well as more frequent procedures such as having blood drawn. These procedures are absolutely critical to efforts to better characterize the mechanisms of immunotherapy and to identify biomarkers to help predict clinical responses to treatment. Over the long run, these studies will help decrease the long testing periods involved with immunotherapy, which will not only help bring new therapies to approval faster but will also make clinical trials less expensive, encouraging additional investment and speeding the delivery of new treatments to patients.
Immunotherapies take longer to work than other therapies. Therefore, it is unlikely that patients will experience an immediate effect. Immunotherapies have also been shown to result in stable, life-extending disease, without any cancer regression. Some patients, who might want results now or to “see” the cancer going away, may find this discouraging.

Common exclusion criteria

Most cancer immunotherapy clinical trials share common eligibility criteria that exclude patients with certain conditions from enrolling. Because immunotherapy depends on a properly functioning immune system, many of these criteria are related to immune dysfunction. Please note that if you meet any of the following criteria, it may be unlikely that you will be eligible to take part in a cancer immunotherapy clinical trial.

Common exclusion criteria include:

Autoimmune conditions, with some exceptions for generally benign conditions such as vitiligo. Commonly excluded conditions include: Addison’s disease, thyroiditis/Hashimoto’s thyroiditis, lupus (SLE), Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome, and Grave’s disease
Prior splenectomy
Active/acute infection requiring antibiotics (e.g., urinary tract infection)
Chronic infection, including HIV, hepatitis B, and hepatitis C
Serious cardiac disease
Active brain metastases (some trials will accept patients with brain metastases if they have been treated and are stable)
If child-bearing potential is not an exclusionary factor outright, trials nearly always stipulate that patients much agree to contraceptive measures during treatment
Recent history of another cancer, typically with the exceptions of non-melanoma skin cancer, superficial bladder cancer, or localized cervical cancer
Immunosuppression, either from such conditions as HIV or from the use of corticosteroids
Life expectancy of less than 3 to 6 months
Poor “performance status” – Trials typically enroll patients with a performance status of 0 (fully active) or 1 (able to do all self-care activities; unable to do hard physical work). Some also include patients with a performance status of 2 (able to do all self-care activities; unable to do any work; spend most of waking time out of bed). Trials rarely enroll patients who are unable to do all self-care activities, unable to do any work, spend most of their waking time in bed (status 3), or who are fully disabled (status 4).

Additional questions to ask about clinical trial enrollment

Several organizations have published lists of recommended questions to ask when considering enrolling in a clinical trial. Some that we recommend include:

National Cancer Institute (NCI), Questions to Ask Your Doctor About Treatment Clinical Trials
The American Cancer Society’s Clinical Trials: What You Need to Know includes answers to frequently asked questions and additional questions you should ask.
The New York Times has also published a list of questions to ask, provided by Steven Goodman, MD, PhD, at the Johns Hopkins Kimmel Cancer Center

What to do next

If you have decided to explore clinical trials, there are several things you can do.

Go to our Clinical Trial Finder to be matched with cancer immunotherapy clinical trials that might be right for you
If you would like to explore other clinical trials of non-immunotherapeutic treatments, go to the National Cancer Institute’s website, select Find a Clinical Trial, and enter the relevant information about your cancer type and stage and your location. If you are interested only in treatment trials, make sure to select the ‘Treatment’ option in the Trial/Treatment Type section. After you select ‘Search,’ you will be directed to a page with a list of all of the clinical trials that meet your criteria. In addition to immunotherapy trials, these may include trials of new chemotherapies or targeted therapies, new combinations of existing drugs or treatment modalities, or new methods to improve drug delivery.

Read stories about patients like you

If you are still unsure about enrolling in a clinical trial, it might help to read stories about people who have participated in cancer immunotherapy clinical trials.

READ PATIENT STORIES

If you have additional questions, email us at [email protected].