Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Clear Cell Renal Carcinoma (Ccrcc), Papillary Renal Cell Carcinoma (Prcc)

In brief

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.

Key facts

Study ID

NCT05665361

Run by

National Cancer Institute (NCI)

People needed

100

Starts

2024-04-24

Expected to finish

2027-06-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
• Prior history of grade >=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible
• An active autoimmune disease. Note: participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (<= the equivalent of prednisone 10 mg/day) or other mild autoimmune disorders not requiring immunosuppressive treatment are eligible.
• Participants receiving systemic corticosteroids at doses equivalent > 10 mg/daily of prednisone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, sirolimus, thalidomide, or anti-tumor necrosis factor [anti-TNF] agents. Note: participants on steroids through a route known to result in minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are eligible
• Prior allogeneic/autologous bone marrow or solid organ transplant
• Participants with current or past hepatitis B (HBV) infection
• Participants with a history of interstitial lung disease, non-infectious pneumonitis, or untreated active/latent pulmonary tuberculosis (TB)
• Participants taking medications that are strong inhibitors or inducers of CYP3A (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions-table-substrates-inhibitors-and-inducers#table3-2) within 21 days or 5 half-lives of the agent (whichever is shorter) prior to initiation of study therapy
• Participants taking any herbal supplements within 14 days prior to initiation of study therapy
• History of a non RCC malignancy within 2 years of treatment initiation except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer, or other malignancy which does not require treatment at the current time per Standard of Care
• Pregnant women (confirmed by beta-HCG serum pregnancy test performed at screening)
• Uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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