A Phase I/II Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
National Cancer Institute (NCI)
Summary
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.
Description
Background: * Kidney cancer is the 8th most common malignancy and 12th leading cause of cancer-related death in the United States. It is estimated that there will be 79,000 new cases of kidney cancer diagnosed in 2022, resulting in 13,920 deaths. Despite a steady increase in the incidence of renal cell cancer (RCC) over the past 3 decades, there has been an improvement in observed 5-year survival rates. * Most patients with advanced clear cell RCC are treated with immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD-1) and/or the CTLA4 axis and agents targeting the v…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: * 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 tr…
Interventions
- DrugSasanlimab
Sasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2).
- DrugPalbocicilib
Palbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland