Do you have metastatic melanoma? Has your cancer progressed after you have been on anti-PD-1/L1 therapy? Stand Up To Cancer (SU2C) is supporting a clinical trial that is studying a potential new immunotherapy treatment for patients like you.
Researchers at the National Cancer Institute (NCI) believe that some tumors may have developed a way to evade the anti-PD-1/L1 therapy by blocking immune cells from attacking the tumor. This study will test the theory that adding an additional treatment, ipilimumab , will make the cancer cells respond once again to the anti-PD-1/L1 therapy.
The trial will be conducted by the NCI through SWOG, a network of cancer clinical trial researchers. The trial will be offered at 47 locations throughout the United States, including national cancer centers, community hospitals, private practices and physician group networks.
Your participation in this study could help researchers find out why immunotherapy treatments sometimes stop working. That could lead to better treatments and improve outcomes for cancer patients in the future.
Here’s a little more about how anti-PD-1/L1 therapy works, to help explain: PD-1 is called a checkpoint protein. It is found on the surface of a type of immune cell. PD-L1 is a related protein found on the surface of some normal cells in the body. The two proteins can attach to one another like a lock and key. When they do, it sends a signal to the immune cells, telling them, “Don’t destroy this cell. It’s normal.” Some cancer cells have a lot of PD-L1. That helps them avoid destruction by the body’s immune system.
Drugs that inhibit PD-1 or PD-L1 can block this binding process, allowing the immune system to respond to the cancer cells. However, many of these drugs work for only a short time.
Key Insights for Participants
What is Ipilimumab?
Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
What is Nivolumab?
Nivolumab is a type of immunotherapy that stops the tumor from repressing the immune system response. It is an antibody that binds to the body’s T cells in order to keep them turned “on” even while the tumor is trying to turn them “off.” These activated T cells (white blood cells that help your body fight disease) can then attack the cancer cells.
Because clinical trials must be carefully tracked, you may receive more attentive care. For example, you will have more access to doctors and nurses to answer questions, get more tests and be closely monitored.
The purpose of this study is to test any good and bad effects of the combination of ipilimumab and nivolumab. While the combination treatment could help the immune system to react to melanoma, reducing the number of cancer cells, it could also cause side effects.
Both ipilimumab and nivolumab have been FDA-approved to treat advanced melanoma, but there has been no FDA approval for using them in this way, to treat melanoma that has previously gotten worse after treatment with an anti-PD-1/L1 drug.
You will be assigned randomly to one of two treatment groups in the study: treatment with a combination of therapies, or treatment with a single drug. You will not be given a placebo (“sugar pill”). You will receive the study drugs as long as your cancer doesn’t get worse, the side effects are tolerable, and you agree to stay in the study.
You will not have to pay for the drugs while you are in the study, but you will be responsible for all the other costs of treating your cancer, including the cost of getting the medicine ready and giving it to you, as well as the cost of tests, procedures, and any medicines to manage your side effects.
Patients with metastatic melanoma, either stage IV or unresectable stage III, progressing on prior anti-PD-1/anti-PD-L1 therapy (ex. nivolumab, pembrolizumab) are eligible to enroll.
Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.
Male or female
18 years and older
Patients with metastatic melanoma whose disease is progressing
You are NOT eligible if you were previously treated with ipilimumab or other CTLA-4 antagonists. You are also NOT eligible if you have had systemic therapy between
the time your disease progressed (while on the anti-PD-1/L1 agent) and your registration for the trial. Systemic therapy before your anti-PD-1/L1 therapy is allowed. You also must not be planning to have any other form of systemic antitumor treatment during the course of this trial.
You must stop taking your anti-PD-1/L1 therapy at least 21 days before you register for this trial.
You can NOT have taken steroids or any other immunosuppressor for at least 14 days before you register for the trial. Inhaled or topical steroids and adrenal
replacement medications (less than 10mg/day of prednisone, for example) are acceptable, as long as you don’t have an active autoimmune disease that would require treatment with steroids during the trial.
You are NOT eligible to participate in this clinical trial if you are pregnant, expecting to conceive a child either during this study or within four months
following your last treatment in this study, or are breast feeding. If you are physically able to become pregnant, you must have a negative pregnancy test (a blood test ordered by your doctor) within the 48-hour period before you start treatment under this study. If you are fertile (both men and women) you must agree to use an effective birth control method from the time of enrollment until 31 weeks after receiving the last treatment dose in this study.
Here are the locations where you can participate in this clinical trial. If you or a loved one is interested, please contact the patient coordinator at your preferred site. The patient coordinator is there to help you understand every aspect of the clinical trial process and can answer any questions you may have.
The patient coordinator will start by reviewing your medical history with you to see whether you meet all the criteria to participate. The coordinator will then guide you through a detailed “informed consent” documents that you are required to sign when you enroll in a clinical trial.
The trials are conducted by National Cancer Institute (NCI) through SWOG network (formerly the Southwestern Oncology Group). Investigators in the SWOG network who are registered members of the SWOG Cooperative Group can enroll patients. Currently, there are 186 sites conducting trials across the country. For more information on SWOG study sites, please visit Swog.org.
Find out if there's a trial for you. Reach out today.
Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service.
(Please fill out all fields and questions below to better assist you.)