Recruiting
Phase 1
Phase 2

Sasanlimab & Palbociclib

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05665361

Conditions

Advanced Clear Cell Renal Carcinoma (Ccrcc)

Papillary Renal Cell Carcinoma (Prcc)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sasanlimab

Palbocicilib

Study Details

Brief 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.

Conditions

Advanced Clear Cell Renal Carcinoma (Ccrcc)

Papillary Renal Cell Carcinoma (Prcc)

Study ID

NCT05665361

Start date

Apr 24, 2024

Status verified date

Jul 27, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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 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 CRITERIA:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1/ Phase I

Sasanlimab and deescalating doses of palbociclib

experimental: 2/Phase II

Sasanlimab and palbociclib at the dose determined in Phase I (RP2D)

Interventions

Sasanlimab

Sasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2).

Palbocicilib

Palbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1.

Primary outcome measure

  • Phase I: To determine RP2D of palbociclib in combination with sasanlimab [ Time Frame: 28 days ]
  • Phase II: Objective response rate (ORR) [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

Wanda A Bell-Farrell

(240) 858-7768wanda.bell-farrell@nih.gov

Ramaprasad Srinivasan, M.D.

(240) 760-6251ramasrin@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Jul 29, 2026

Last verified

Jul 27, 2026

Keywords

  • Papillary Renal Cell Carcinoma
  • Kidney Neoplasms
  • Kidney Cancer
  • Clear Cell Renal Cell Carcinoma
  • Translocation Renal Cell Carcinoma
  • TFE3-rearranged renal cell cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-07-29.