Background:
Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments. Better treatments are needed.
Objective:
To test a pair of drugs (sasanlimab and palbociclib) in people with kidney cancers.
Eligibility:
People aged 18 years and older with kidney cancer; specifically, clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC).
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan and a test of their heart function. They may have a biopsy; that is, a sample of tissue will be cut from the tumor.
Participants will be treated in 28-day cycles for up to 2 years.
Palbociclib is a pill taken by mouth. Participants will take this drug once a day for 21 days during each 28-day treatment cycle. They will write down the dates and times they take these pills in a diary.
Sasanlimab is an injection under the skin. Participants will receive this injection on the first day of each treatment cycle.
Imaging scans and blood tests will be repeated throughout the treatment. Tumor biopsies may be repeated up to 3 times; these biopsies are optional.
Participants will have follow-up visits every month for 3 months after treatment ends. They will continue to have imaging scans every 3 months; these scans may be done close to home. The results can be sent to researchers.
Participants will remain in the study up to 6 years.
Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)
Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1.
Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)
Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC
Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
More than four prior lines of systemic therapy in the metastatic setting
Participants who have wound dehiscence from prior surgeries
Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of palbociclib
Sequential
Sasanlimab
DrugSasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2).
Palbocicilib
DrugPalbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1.
Phase I: To determine RP2D of palbociclib in combination with sasanlimab
Number of DLTs within DLT period
Phase II: Objective response rate (ORR)
Responses (PR+CR) in participants based on imaging \[CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)\] performed every 8 (+/-1) weeks for 32 weeks and every 12 (+/-1) weeks after that until the first of either disease progression or 6 years after enrollment
Disease Control Rate (DCR) defined as PR + CR+ SD in participants re-treated with the study drug combination by RECIST 1.1
DCR as assessed by imaging \[CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)\] performed every 8 (+/-1) weeks for 32 weeks and every 12 (+/-1) weeks after that until the first of either disease progression or 6 years after enrollment
progression-free survival (PFS)
Progression free survival determined by imaging \[CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)\] performed every 8 (+/-1) weeks for 32 weeks and every 12 (+/-1) weeks after that until the first of either disease progression or 6 years after enrollment
safety of the combination of palbociclib and sasanlimab
Any toxicities identified between Day 1 of Cycle 1 through 90 days after the study agent (s) was/were last administered will be collected and reported by type and grade. Beyond 90 days after the last intervention, only adverse events which are serious and related to the study intervention will be recorded and reported. Note: during re-treatment AEs will be documented from the re-start of the study intervention through 90 days after the study agent (s) was/were last administered. Beyond 90 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded
overall survival (OS)
Participants assessed at Day 1 of every cycle, safety follow up visits at days 30, 60, 90, every 12 weeks until progression and/or every 6 months after progression for 6 years after enrollment.
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