SWOG, a part of National Cancer Institute’s National Clinical Trials Network and the NCI Community Oncology Research Programme, has launched the DART immunotherapy trial of ipilimumab and nivolumab (Opdivo) to treat rare cancers.
Ipilimumab is a monoclonal antibody drug that inhibits cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a molecule considered important in relating natural immune responses.
This leads in sustaining an active immune response in its attack on cancer cells.
Nivolumab is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1, which is used by the cancer cells to take refuge from the immune system and block the tumour from being exposed to the immune system.
NCI has entered into collaborative agreements with Bristol-Myers Squibb to conduct the Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumours (DART) trial.
DART principal investigator and UC San Diego Moores Cancer Center Clinical Trials Office assistant professor of medicine and assistant director Dr Sandip Patel said: “NCI-MATCH’s goal was to include rare cancer patients as part of the trial, and with DART, we hope to increase the impact by offering them this dual immunotherapy.
“This trial is an extraordinary team effort between multiple cancer centres connected by SWOG.”
The trial will enrol 300 patients who are registered to NCI-MATCH, a precision medicine trial co-designed by ECOG-ACRIN Cancer Research Group and the NCI, and led by ECOG-ACRIN in the US.
People who do not have any treatment option under NCI-MATCH or were not responsive to the trials and their rare cancer is eligible will be considered for the trial.
During the trial, the patients will be administered with ipilimumab and nivolumab in combination, which is currently approved by the US Food and Drug Administration (FDA) to treat melanoma and being tested to treat lung cancers.
The trial is intended to determine the combination efficacy in reducing tumours based on computerised tomography (CT) after six weeks of treatment.
Investigators will also assess side effects in patients, survival duration of the patients and time before progression of cancer.
Additionally, a basic science team will examine tumour tissue samples to analyse immune cell and gene responses to the drug combination and identify the presence of biomarkers to predict treatment response among patients.