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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). 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.
Primary Outcome
Here is the maximum tolerated dose (MTD) (i.e., highest dose) of rhIL-15 administered in combination with fixed doses of nivolumab and ipilimumab at which dose-limiting toxicities occurred in ≤1 of 6 participants during cycle 1, dose escalation in participants receiving the triplet combination. A DLT is defined as an adverse event that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring lon
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 |
What the finished NCT03388632 record still lists
NCT03388632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03388632 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03388632's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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