The Medical University of South Carolina (MUSC), an academic medical center in Charleston, is enrolling participants for a Phase 1b/2 clinical trial to test whether a new combination of two drugs can enhance the immune system in patients suffering from lung cancer. The trial is titled “ALT-803 plus nivolumab in patients with pretreated, advanced or metastatic non-small cell lung cancer.”
Lung cancer has two primary types: small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC is considered the most common type of lung cancer, and it is relatively insensitive to chemotherapy treatment. This clinical trial will specifically target patients with NSCLC to determine if immunotherapy can be improved using a combination of two powerful drugs, nivolumab (a chemotherapy agent) and ALT-803 (an agonist of interleukin 15, a cytokine which has potent antitumor activity).
“While recently approved immunotherapies are extremely exciting and better than chemotherapy for second-line therapy, about 80 percent of patients will not respond,” Dr. John Wrangle, principal investigator of the trial and medical oncologist, said in a news release.
“By combining two kinds of immunotherapy, we feel we have designed a treatment that is very promising to extend the remarkable benefit experienced by some patients to a larger percentage of people with advanced lung cancer,” Wrangle said.
In the trial, the team will evaluate the efficacy of the drug combination nivolumab plus ALT-803, and examine how patients react to this therapy.
Nivolumab is a checkpoint inhibitor drug that blocks ligand activation of the programmed cell death to assist healthy cells fighting tumors. The efficacy of this drug administrated alone was shown only in about 5 percent of the patients. On the other hand, the drug created by Altor Bioscience, ALT-803, is a powerful immune stimulation factor that is supposed to boost the power of nivolumab.
“Instead of simply cutting the brake cables of the immune cells using only a checkpoint blocker, we are also adding fuel in the form of ALT-803 so the immune cells will have optimal stimulation and ability to kill tumor cells,” said Mark Rubinstein, Ph.D., a member of the research team who designed the trial.
For more information about the clinical trial and how to participate, call Amanda Gilbert at 843-792-8795.