18 and older, any sex, with Clear-Cell Renal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (Complete Response + Partial Response)Primary· Following start of study medication while on treatment, approximately 2 months.
Response was assessed using the Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST)v1.1. Immune related complete response (irCR) is at least two radiographic determinations of complete response (CR - e.g., disappearance of all target lesions) at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease ((PD - e.g., appearance of one or more new lesions) at least 4 weeks apart). at least 4 weeks apart). Immune related partial response (irPR) is at least two radiographic dete
Immune related complete response (irCR)
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
0
Immune related partial response (irPR)
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
0
Duration of ResponseSecondary· Following start of study medication while on treatment, up to 1-2 months.
Duration of response is defined as the time from the initial response (irCR, irPR or irSD) to progression or death, whichever comes first. Response was assessed using the Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST)v1.1. Immune related complete response (irCR) is at least two radiographic determinations of complete response (CR) at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease (PD) at least 4 weeks apart). Immune related partial response (irPR) is at leas
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
13
0 – 26
Progression-free SurvivalSecondary· Monitoring frequency is every two cycles through completion of study then annually until progressive disease is noted, an average of 73 days.
Progression free survival is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever comes first. Progression was assessed using the Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST)v1.1. Immune related progressive disease (irPD) is defined as at least two consecutive radiographic determinations of progressive disease (PD - e.g., appearance of one or more new lesions) at least 4 weeks apart).
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
73
62 – 84
Overall SurvivalSecondary· time from the date of study enrollment until time of death from any cause, an average of 167 days
Overall survival is defined as the time from the date of study enrollment until time of death from any cause.
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
167
147 – 187
Number of Grade 3 Adverse Events Possibly, Probably or Definitely Related to Treatment of rhIL-15 + AvelumabSecondary· 4 cycles (each cycle is 28 days), up to 112 days
Adverse events were assessed using the Common Terminology Criteria for Adverse Events (CTCAE)v5.0. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.
Grade 3
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
0
Grade 4
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
0
Grade 5
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
0
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).Secondary· Date treatment consent signed to date off study, approximately 13 months and 24 days.
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
Group
Value
95% CI
Arm 1- Safety Run-in Dose Level 1
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 13 months and 24 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
-Clear-cell renal cell carcinoma (ccRCC) is a kind of kidney cancer. The drug avelumab may help direct the immune response to the tumors and can prolong the immune response. The drug Interleukin-15 (IL-15) stimulates certain kinds of white blood cells that have the potential to attack the cancer.
Objective:
-To test whether IL-15 and avelumab administered together are safe and effective at treating ccRCC.
Eligibility:
-People ages 18 and older with relapsed, metastatic biopsy proven clear cell renal cell carcinoma (ccRCC) that has not responded to standard treatments
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Blood, urine, heart, and lung tests
* Computed tomography (CT) and positron emission tomography (PET) scans and possible MRI: Participants will lie in a machine that takes pictures of the body. For the CT scan, they may receive an oral contrast agent by mouth and normally receive IV contrast through a vein to improve the x-ray images.
* Tumor sample to confirm expression of avelumab target: If one is not available, participants will require a new biopsy that is generally obtained by a needle that is inserted into the tumor.
Participants will get the study drugs by vein for up to four 28-day cycles. The IL-15 will be given through a vein continuously for the first 5 days (120 hours) of each cycle. They avelumab will be given through a vein over about 1 hour on days 8 and 22 of each cycle. Participants will be hospitalized for their 1st week of IL-15 cycle and may be able to receive their subsequent IL-15 treatment as an outpatient depending on their side effects. Participants who receive the infusion as an outpatient will return to the hospital each day for a new bag of IL-15. Participants who cannot or do not want to be treated as an outpatient will be treated in the hospital during their 5-day IL-15 infusions.
* Participants will need a midline venous catheter which is longer than a standard venous catheter but is still inserted into a peripheral vein in their arm.
* Participants will have repeats of blood tests to monitor the blood counts and chemistry throughout the study.
* Participants will have follow-up visits 30 days after their last treatment, every 60 days for the first 6 months, every 90 days for 2 years, then every 6 months.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06995872 — Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refra
· Phase 1
· recruiting
NCT03759184 — Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
· Phase 1
· terminated
NCT03905135 — Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
· Phase 1
· completed
NCT03388632 — Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 17 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04150562.