This phase I trial studies the side effects and best dose of aldesleukin when given together
with pembrolizumab in treating patients with kidney cancer that has spread to other parts of
the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to avoid
recognition by immune cells. Giving aldesleukin and pembrolizumab may work better in treating
patients with kidney cancer.
I. To evaluate the safety and tolerability of aldesleukin (IL-2) combined with pembrolizumab
(MK-3475) in patients with metastatic clear cell renal cell carcinoma (RCC).
I. To assess preliminary antitumor activity of pembrolizumab in combination with IL-2.
I. To investigate the association of PD-L1 protein expression by pretreatment tumor with
response to treatment.
II. To investigate the association of regulatory T cell (Treg) frequency and Treg to effector
T cell (Teff) ratios in peripheral blood and tumor tissue with response to therapy.
III. To investigate the association of de novo serological and cellular responses against the
ubiquitous RCC tumor antigen 5T4 with response to therapy.
IV. To investigate the association of tumor infiltrating lymphocyte (TIL) repertoire
clonality with response to therapy and to assess the detection of dominant TIL clones within
peripheral blood over time in responding patients.
V. To investigate the association of whole genome copy number alterations measured on
pretreatment archived, formalin fixed, paraffin embedded (FFPE) tumor with response to
OUTLINE: This is a dose-escalation study of aldesleukin.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Patients also
receive aldesleukin subcutaneously (SC) 5 days per week for 6 weeks; or aldesleukin IV on
days 2-6 of pembrolizumab cycles 1 and 2. Pembrolizumab treatment repeats every 3 weeks for 4
cycles per treatment course in the absence of clinical disease progression or unacceptable
After completion of study treatment, patients are followed up via surveillance scans for
every 3 months for up to 1 year or until disease progression.
Malignant neoplasm of kidney,
Renal Cell Carcinoma,
Stage IV Renal Cell Cancer,
Stage III Renal Cell Cancer,
Renal Cell Cancer,
clear cell renal cell carcinoma,
stage iv kidney cancer
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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