OncoMatch/Clinical Trials/NCT05665361
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
Is NCT05665361 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Sasanlimab and Palbocicilib for advanced clear cell renal carcinoma (ccrcc).
Treatment: Sasanlimab · Palbocicilib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: checkpoint inhibitor
Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy
Must have received: VEGF pathway antagonist
must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)
Cannot have received: chemotherapy
Prior treatment for RCC with chemotherapy...within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
Cannot have received: hormonal therapy
Prior treatment for RCC with...hormonal therapy...within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
Cannot have received: immunotherapy
Prior treatment for RCC with...immunotherapy...within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
Cannot have received: experimental agent
Prior treatment for RCC with...treatment with an experimental agent...within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
Cannot have received: radiation therapy
Prior treatment for RCC with...radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1,000/microliter; Hemoglobin (Hb) >= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation; Platelets >= 100,000/microliter
Kidney function
Serum creatinine <= 1.5 x ULN OR, if >1.5x ULN, creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2 (calculated CrCl (CKD-EPI or calculated eGFR provided by laboratory))
Liver function
Total bilirubin <= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin <= 3.0 x ULN; ALT and AST <= 2.5 x ULN, (unless liver metastases are present, then values must be <= 5 x ULN)
Adequate hematologic function at screening...Adequate renal and hepatic function at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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