Palbociclib and Sasanlimab for Advanced Kidney Cancer
This study is testing two drugs, palbociclib and sasanlimab, for people with advanced clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC), which are types of kidney cancer. Researchers want to find the best dose of palbociclib when given with sasanlimab, and see how many people respond to this combination. Palbociclib works by blocking certain proteins (CDK4 and CDK6) that help cancer cells grow, while sasanlimab is a type of immunotherapy (checkpoint inhibitor) that helps your immune system fight cancer. You may be eligible if you are 18 or older and have one of these kidney cancer types with at least one measurable tumor.
- Study design
- This is an interventional study planning to enroll 100 participants. The phase of the study is not specified, and the status is currently unclear.
- What's involved
- You will be treated in 28-day cycles for up to 2 years. Palbociclib is a pill taken by mouth, and sasanlimab is given as an injection under the skin.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured for up to 6 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05665361
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~100 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:SasanlimabPalbocicilib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: To determine RP2D of palbociclib in combination with sasanlimab
Measured over 28 days
+1 more outcome measured
Conditions
NCT05665361
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ramaprasad Srinivasan, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Age \>= 18 years
ECOG performance status \<= 1
Adequate hematologic function at screening, as follows:
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
Adequate renal and hepatic function at screening, as follows:
Serum creatinine \<= 1.5 x upper limit of normal (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))
Total bilirubin \<= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \<= 3.0 x ULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN, (unless liver metastases are present, then values must be \<= 5 x ULN)
Participants serologically positive for hepatitis C virus (HCV) are eligible if HCV viral load is undetectable
Participants serologically positive for human immunodeficiency virus (HIV) are eligible if they are on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \>= 200 cells per cubic millimeter
Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms
Women of child-bearing potential (WOCBP) must agree to use one (1) highly effective method of contraception (e.g.,hormonal, intrauterine device (IUD), surgical sterilization) prior to study entry, for the duration of study therapy, and for up to 6 months following the last dose of any study agent(s). Women must refrain from donating eggs during this same period. NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.
Men with female partners of reproductive potential and pregnant partners are required to use a condom (even after vasectomy), during treatment and for at least 6 months after the final dose and must refrain from donating sperm during this same period.
Breastfeeding participants must be willing to discontinue breastfeeding from study enrollment through 6 months after study treatment discontinuation
Participants must be able to understand and be willing to sign a written informed consent document
Exclusion
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.
What this trial measures
- Phase I: To determine RP2D of palbociclib in combination with sasanlimab28 days
Number of DLTs within DLT period
- Phase II: Objective response rate (ORR)6 years
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