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Treatment-Refractory Cancers clinical trials

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NCT ID: NCT03388632 Recruiting - Clinical trials for Metastatic Solid Tumors

Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers

Start date: February 5, 2018
Phase: Phase 1
Study type: Interventional

Background: The drug IL-15 activates the immune system. The drugs nivolumab and ipilimumab unblock immune cells. The drugs together may allow immune cells to recognize and attack cancer cells, causing tumors to shrink. Objective: To test the effects and maximum dose of IL-15, nivolumab, and ipilimumab. Eligibility: People ages 18 and older who have cancer that does not respond to treatment Design: Participants will be screened with: - Medical history - Physical exam - Heart, blood, and urine tests - Scans Tumor biopsy: A small needle removes a tumor sample. Participants will be in 1 of 3 treatment groups: - IL-15 with nivolumab - IL-15 with ipilimumab - IL-15 with nivolumab and ipilimumab Participants will take the drugs in four 6-week cycles. IL-15 is injected under the skin. The other two drugs are injected into an arm vein over 60-90 minutes. Participants may need to stay at the hospital 2-3 hours after the first dose of any drug to watch for side effects. Each cycle will include: - Weekly blood and urine tests - 5 IL-15 injections - 1 ipilimumab injection if applicable - 3 nivolumab injections if applicable - Scans and a tumor biopsy on day 42 After cycle 4, participants will stop taking IL-15. They will continue the other drugs until they can no longer tolerate the side effects or their cancer gets worse. Those cycles will include: - Blood tests on 3-4 days - Urine tests on 1 day - 1 ipilimumab injection if applicable - 3 nivolumab injections if applicable - Scans every other cycle After participants stop treatment, their doctor will monitor their side effects for 4 months or until they go away.