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NCT03388632 · ClinicalTrials.gov registry record · Phase 1
Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03388632: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03388632 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03388632, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Background: The drug Interleukin-15 (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 * 16 IL-15 injections * 1 ipilimumab injection if applicable * 3 nivolumab injections if applicable * Blood tests weekly during cycles 1 and 2 * Urine tests weekly during cycles 1 and 2 * 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: * 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.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG rhIL-15
- DIAGNOSTIC_TEST EKG
- PROCEDURE Tumor biopsies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03388632
The ClinicalTrials.gov registry entry for NCT03388632 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03388632 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03388632 about?
NCT03388632 is a clinical study titled "Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers". Background: The drug Interleukin-15 (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, niv...
What is the current status of trial NCT03388632?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2018-02-05. Estimated completion is 2025-05-08.
What interventions are being tested in trial NCT03388632?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), rhIL-15 (DRUG), EKG (DIAGNOSTIC_TEST), Tumor biopsies (PROCEDURE).
Who is sponsoring clinical trial NCT03388632?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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