Actively Recruiting
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
Led by National Cancer Institute (NCI) · Updated on 2026-04-07
100
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed clear cell renal cell carcinoma with a clear cell component or papillary renal cell carcinoma with a papillary component
- Advanced renal cell carcinoma with at least one measurable lesion per RECIST 1.1
- For clear cell RCC: prior checkpoint inhibitor therapy and prior or ineligible for VEGF pathway antagonist treatment
- For papillary RCC: treatment-naive or previously treated systemically
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate blood counts: ANC ≥ 1,000/microliter; Hemoglobin ≥ 9 g/dL without recent transfusion; Platelets ≥ 100,000/microliter
- Adequate kidney and liver function per specified laboratory criteria
- Stable hepatitis C virus infection if positive, with undetectable viral load
- Stable HIV infection if positive, on antiretroviral therapy for at least 4 weeks, no recent opportunistic infections, undetectable viral load, and CD4 count ≥ 200 cells/mm3
- Brain metastases allowed if stable for at least 4 weeks after treatment with no progression or symptoms
- Women of child-bearing potential agree to use effective contraception during and 6 months after treatment
- Men with partners of reproductive potential agree to use condoms during and 6 months after treatment
- Willingness to discontinue breastfeeding during and 6 months after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatments with chemotherapy, hormonal therapy, immunotherapy, experimental agents, or radiation within 4 weeks or 5 half-lives before starting treatment
- More than four prior lines of systemic therapy in metastatic setting
- Wound healing problems from previous surgeries
- Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, or other conditions affecting drug absorption
- Allergic reactions to similar compounds as study drugs
- History of severe (grade 3 or higher) immune-related adverse events from checkpoint inhibitors, except endocrine toxicities
- Active autoimmune diseases requiring immunosuppressive treatment (some mild autoimmune conditions allowed)
- Use of systemic corticosteroids or immunosuppressive drugs above specified doses
- Prior bone marrow or solid organ transplant
- Current or past hepatitis B infection
- History of interstitial lung disease, pneumonitis, or untreated active/latent tuberculosis
- Use of strong CYP3A inhibitors or inducers within 21 days before treatment
- Use of herbal supplements within 14 days before treatment
- History of non-renal cancer within 2 years except certain treated localized cancers
- Pregnancy confirmed by test
- Uncontrolled illnesses that would limit study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
W
Wanda A Bell-Farrell
CONTACT
R
Ramaprasad Srinivasan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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