Trial · NCT03388632
Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers
NCT03388632, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2025-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers. Trials, record NCT03388632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03388632
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers
- NCT number
- NCT03388632
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Solid Tumors, Treatment-Refractory Cancers
- Interventions
- rhIL-15, Ipilimumab, Nivolumab, Tumor biopsies, EKG, ECHO, CT Scan
- First posted
- 2018-01-03
- Last updated
- 2025-12-18
- Results first posted
- 2025-12-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) at Which Dose-Limiting Toxicities (DLT) Occurred With rhIL-15 Administered in Combination With Fixed Doses of Nivolumab and Ipilimumab | Cycle 1 (42 days) | 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 long-term treatment with corticosteroids or permanent discontinuation of one of the agents. |
| Primary | Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Cycle 1 (42 days) | A DLT is defined as an adverse event (AE) that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents. |
| Primary | Number of Participants Experiencing Dose-Limiting Toxicities (DLT) | Cycle 1 (42 days) | Here is the number of participants experiencing dose-limiting toxicities (DLT). 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 long-term treatment with corticosteroids or permanent discontinuation of one of the agents. |
| Secondary | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) at Which Dose-Limiting Toxicities (DLT) Occurred With rhIL-15 Administered in Combination With Fixed Doses of Nivolumab and Ipilimumab | Cycle 1 (42 days) | This analysis includes participants (pts) from multiple groups, as different groups received different doses of rhIL-15. Includes pts from group 4 (n=2), group 5 (n=9), group 6 (n=2), group 7 (n=1), group 8 (n=2), and group 9(n=1). Of the 18 pts in group 5, 9 pts were enrolled in the dose escalation phase to determine MTD \& an additional 9 pts were enrolled in an expansion cohort at that dose after the MTD was determined. Pts in this expansion cohort were not included in the MTD determination. | mcg/kg/day | NUMBER |
| PRIMARY | Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Cycle 1 (42 days) | As pre-specified in the protocol, DLT's were assessed in the lead-in doublet arms and the triplet escalation phase groups only. | toxicities | NUMBER |
| PRIMARY | Number of Participants Experiencing Dose-Limiting Toxicities (DLT) | Cycle 1 (42 days) | Of the 18 participants in group 5, 9 participants were enrolled in the dose escalation phase to determine maximum tolerated dose (MTD), and an additional 9 participants were enrolled in an expansion cohort at that dose after the MTD was determined. Participants in this expansion cohort were not included in this DLT evaluation per protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) at Which Dose-Limiting Toxicities (DLT) Occurred With rhIL-15 Administered in Combination With Fixed Doses of Nivolumab and Ipilimumab | All Participants in Escalation Phase of Arm C | 1.0 | mcg/kg/day | ||
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities | |
| Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs | Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | Possibly related to rh IL-15 | 0 | toxicities |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-In Doublet A | STARTED | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 2 | |
| Lead-In Doublet A | STARTED | Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 1 | |
| Lead-In Doublet A | STARTED | Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | STARTED | Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | STARTED | Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | STARTED | Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | STARTED | Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | STARTED | Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | STARTED | Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | |
| Lead-In Doublet A | COMPLETED | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 2 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events1,809
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 0 | 1 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 18 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 1 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | 1 | 1 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 0 | 2 | 0 |
1 to 10 of 1,809Source ClinicalTrials.gov
See all 1,809 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 0 | 2 |
| Total, all-cause mortality | Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 0 | 1 |
| Total, all-cause mortality | Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg | 0 | 2 |
| Total, all-cause mortality | Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 2 |
| Total, all-cause mortality | Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 1 | 18 |
| Total, all-cause mortality | Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 2 |
| Total, all-cause mortality | Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 1 |
| Total, all-cause mortality | Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 2 |
| Total, all-cause mortality | Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg | 0 | 1 |
| Total, other adverse events | Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg | 2 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03388632
GET https://conductscience.org/api/trials/v1/NCT03388632/results?page=2