Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
A Phase I/II Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 27, 2022
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 9, 2026
March 5, 2026
3.1 years
December 23, 2022
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I: To determine RP2D of palbociclib in combination with sasanlimab
Number of DLTs within DLT period
28 days
Phase II: Objective response rate (ORR)
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
6 years
Secondary Outcomes (4)
Disease Control Rate (DCR) defined as PR + CR+ SD in participants re-treated with the study drug combination by RECIST 1.1
6 years
progression-free survival (PFS)
6 years
safety of the combination of palbociclib and sasanlimab
6 years
overall survival (OS)
6 years
Study Arms (2)
1/ Phase I
EXPERIMENTALSasanlimab and deescalating doses of palbociclib
2/Phase II
EXPERIMENTALSasanlimab and palbociclib at the dose determined in Phase I (RP2D)
Interventions
Sasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2).
Palbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1.
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramaprasad Srinivasan, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2022
First Posted
December 27, 2022
Study Start
April 24, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data from this study may be requested by other researchers at the time of publication or shortly thereafter. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active
- Access Criteria
- Data from this study may be requested by contacting the PI. Genomic data are made available via dbGaP through requests to the data custodians.
All large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with other investigators after publication in accordance with the executed CRADA.