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

• Status: Recruiting
• Trial end date: 2022-12-01

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Ipilimumab; Nivolumab