The National Cancer Institute (NCI) is conducting the first federally funded immunotherapy trial devoted to rare cancers.
Such cancers occur in only six of 100,000 people per year. Anyone in this category can join the nationwide trial, which is called DART — for Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors. The trial (NCT02834013) will assess the effectiveness of combining the anti PD-1 therapy Opdivo (nivolumab) with the anti-CTLA-4 treatment Yervoy (ipilimumab).
The trial will be directed by SWOG, the cancer clinical trials group of the National Clinical Trials Network (NCTN), which is part of the National Cancer Institute.
DART will draw participants from another landmark NCTN trial, the huge NCI-MATCH effort (NCT02465060).
More than 1,000 clinical sites are involved in NCI-MATCH. It is testing a large number of genes in patients with any solid tumor, or who have lymphoma or myeloma.
The object is to match gene mutations with one of 24 targeted treatments offered in the trial. The researchers plan to add 10 more treatments later.
Patients eligible for the DART trial must be registered with NCI-MATCH but lack a treatment option under that trial, or have a cancer that has progressed during one of the treatments offered.
“We are hopeful that with the help of the rare-disease community, and patients throughout the U.S., this pivotal trial will advance more treatments for people with rare cancers,” Marcia Horn, SWOG’s patient advocate for early therapeutics and rare cancers, said in a news release. She is president and CEO of the International Cancer Advocacy Network.
The Opdivo-Yervoy combination being tested in the DART trial, which boosts the immune system’s ability to fight cancer, has already been approved for melanoma patients. It is being tested now in a variety of lung cancers.
DART researchers want to see if the combination, given in six-week cycles, will work in rare cancers.
Computer tomography (CT) will be used to assess the patients. The first scan will be done when the patient enrolls. Others will occur at regular intervals to see whether the combo treatment is shrinking tumors. Researchers will also assess patients’ progression-free survival and overall survival rates.
In addition, the team will study patients’ tumor samples to understand how immune cells and genes from each tumor respond to the combo therapy. The study will include up to 300 patients.
“DART could have strong science benefits by allowing us to explore the genomic landscape of rare tumors and their response to combination immunotherapy,” said Dr. Young Kwang Chae, principal investigator of DART’s translational medicine unit. He is assistant professor in the Division of Hematology/Oncology at the Feinberg School of Medicine at Northwestern University, and co-director of the division’s Developmental Therapeutics Program.