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NCT04150562 · ClinicalTrials.gov registry record · Phase 2
Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT04150562: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04150562 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150562, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
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 cat
Interventions
- BIOLOGICAL Avelumab
- DRUG rhIL-15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04150562
The ClinicalTrials.gov registry entry for NCT04150562 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 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 2 interventions - of which Avelumab is the first listed.
NCT04150562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04150562 about?
NCT04150562 is a clinical study titled "Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma". 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 t...
What is the current status of trial NCT04150562?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2020-05-26. Estimated completion is 2021-09-16.
What interventions are being tested in trial NCT04150562?
The interventions under investigation include: Avelumab (BIOLOGICAL), rhIL-15 (DRUG).
Who is sponsoring clinical trial NCT04150562?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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