Clinical Trials for Immunotherapy & HIFU

Clinical Trial:  Phase II DART Immunotherapy

Despite their name, rare cancers make up more than 20 percent of cancers diagnosed worldwide. DART is a clinical trial testing new treatments for dozens of rare cancers. Desmoid tumor is one of the tumor types included in this trial.

The two drugs under study are new FDA-approved immunotherapies. Immunotherapies are a new class of cancer drugs designed to help a patient’s own immune system fight their cancer. DART is the first federally funded immunotherapy trial devoted to rare cancers. DART stands for Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors.

Rare cancers are those with less than a 6 in 100,000 incidences per year, according to the definition used for the DART trial. But only certain rare cancer patients can enroll in DART. Prospective patients submit tumor tissue for a genetic test, and doctors will use the test results to see if a patient’s type of cancer is covered under the DART trial. Doctors will also screen patients using other eligibility criteria, including the stage of their disease, their general health, and any prior treatment.

Once enrolled in DART, patients are treated with two immunotherapy drugs under the brand names Yervoy (ipilimumab) plus Opdivo (nivolumab). The FDA approved the combination to treat melanoma, and the combination is currently being tested on a variety of lung cancers. DART patients will receive both drugs. There is no placebo.

DART investigators want to determine if this combination, given in six-week cycles, can significantly shrink tumors. In addition, a basic science team will use patients’ tumor tissue samples to study how immune cells and genes respond to the drug combination, and see if there are any substances that can be measured in their tissue sample that may predict treatment response. Trial leaders plan to enroll 300 patients.

Rare cancer patients should discuss with their doctor whether DART is right for them. For study eligibility and locations, visit the link below. Please contact with any questions.

More about the DART trial at

Read the original press release here.


Clinical Trial:  MR-guided High Intensity Focused Ultrasound (HIFU) for Patients Under 30 Years Old

Children’s National Health System has an open clinical trial using magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU), a noninvasive technology, to destroy solid tumors including desmoid tumors in children, adolescents, and young adults. To be eligible for the clinical study, patients need to be 30 years or less with refractory or relapsed solid tumors including desmoid tumors with measurable lesions that are located in bone or soft tissue in close proximity to bone. To learn more or to enroll in the trial, please see or contact Emily Stern, RN at 202-476-2802 (email: or AeRang Kim, MD, PhD at 202-476-2800 (email:

More about HIFU clinical trials

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