Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma
Status:
Completed
Trial end date:
2021-09-16
Target enrollment:
Participant gender:
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
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
- CT and 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 be 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.