Trials in rare cancers are extraordinarily difficult to run. That's why the last two National Clinical Trials Network grant applications have asked for detailed explanations of how the cooperative groups plan to be successful in that arena. Are rare cancers just too scarce to accrue patients? That's been the thinking for years.

But, as SWOG Vice Chair Dr. Anne Schott and SWOG Breast Cancer TM chair Dr. Dan Hayes pointed out at ESMO in 2016, there are a lot of opportunities here right now. Those opportunities have successfully been seized by the team behind DART, SWOG's rare cancers study. Launched in January 2017, DART in just a year has enrolled over 300 patients, to surprise and delight.

DART stands for short for Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors, and it's a unique federally funded immunotherapy clinical trial. It was conceived by SWOG investigators Drs. Sandip Patel, Razelle Kurzrock, Young Kwang Chae, and former SWOG investigator Dr. Frank Giles. With quite an effort from SWOG statisticians Megan Othus, Melissa Plets, and Edward Mayerson, the group came up a "basket” master protocol design.

The trial is testing the effectiveness of one immunotherapy combination – ipilimumab and nivolumab from Bristol-Myers Squibb – in dozens of different rare tumors. To date, DART has opened 37 cohorts, each containing patients with a single rare cancer type, including subsets of cancers of the ovary, small intestine, lung, sinuses, pancreas, breast, and more. Members have more than responded well, with more than 750 clinical sites opening the trial to their patients.

The trial has been well received by our partners at the National Cancer Institute, as well as advocates for rare cancers. It also netted a cover story in The Cancer Letter.

We're celebrating the success of DART with a press release on the eve of international Rare Disease Day. I couldn't be prouder of the DART team and the opportunity they're providing for patients with rare cancers, who often have little or no good treatment options.

I thank everyone who believed in this project.

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