Advanced Clear Cell Renal Carcinoma (Ccrcc)Phase 1/2NCT05665361
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
A Phase 1/2 study testing Sasanlimab and Palbocicilib in people with Advanced Clear Cell Renal Carcinoma (Ccrcc) and Papillary Renal Cell Carcinoma (Prcc), run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Clear Cell Renal Carcinoma (Ccrcc), Papillary Renal Cell Carcinoma (Prcc)
- What is being tested?
- Sasanlimab and Palbocicilib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 1 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: 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)
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.
Read more
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.
Read the detailed description
Background:
- Kidney cancer is the 8th most common malignancy and 12th leading cause of cancer-related death in the United States. It is estimated that there will be 79,000 new cases of kidney cancer diagnosed in 2022, resulting in 13,920 deaths. Despite a steady increase in the incidence of renal cell cancer (RCC) over the past 3 decades, there has been an improvement in observed 5-year survival rates.
- Most patients with advanced clear cell RCC are treated with immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD-1) and/or the CTLA4 axis and agents targeting the vascular endothelial growth factor (VEGF) pathway. There is a paucity of options for patients who have progressed on these therapies. There is currently no widely accepted standard for patients with papillary RCC, although some patients may benefit from agents such as cabozantinib or the combination of bevacizumab and erlotinib.
- Preclinical data suggest that inhibitors of CDK 4/6 might be active in kidney cancer and that these agents might act synergistically with PD-1 checkpoint inhibitors in a variety of preclinical models.
- Palbociclib is a highly selective, reversible oral inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Inhibition of CDK 4/6 blocks DNA synthesis by prohibiting the progression of the cell cycle from G1 to the S phase. Data from nonclinical studies indicate that palbociclib may have cytostatic effects on tumor cells.
- Sasanlimab is an investigational humanized immunoglobulin G4 monoclonal antibody that binds PD-1 and blocks its interaction with its ligands, programmed death-ligand 1 and 2 (PD-L1) \& (PD-L2). It presents the distinct characteristic that it can be administered subcutaneously on a monthly basis whereas approved and other available anti-PD-1/PDL1 therapies currently are administered intravenously. In animal models, it demonstrated high-affinity interaction with PD 1 and was associated with a significant delay in the growth of murine MC-38 colorectal tumors implanted in hu-PD-1 knock-in mice.
Objectives:
- Phase I: To determine recommended phase II dose (RP2D) of palbociclib in combination with sasanlimab
- Phase II: To determine the overall response rate (ORR) defined as partial response (PR) + complete response (CR) of the RP2D of the combination of palbociclib and sasanlimab in participants with advanced ccRCC (Cohorts 1a and 2a) and advanced pRCC (Cohorts 1b and 2b) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Eligibility:
- Age 18 years or older
- Participants with histologically or cytologically confirmed advanced ccRCC or pRCC
- Participants must have measurable disease per RECIST 1.1
- ECOG performance status <= 1
- Adequate organ function as defined by the liver, kidney, and hematologic laboratory testing
- Participants with ccRCC 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 can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC.
- No more than four prior lines of therapy in the metastatic setting.
Design:
- The proposed study is an open label, phase I/II study of palbociclib in combination with sasanlimab
- Participants will be enrolled simultaneously into Cohort 1a (ccRCC) and Cohort 1b (pRCC) and start treatment in cycles consisting of 28 (+/- 5) days
- Initially, 6-18 participants from Cohort 1a and/or Cohort 1b will be enrolled into Phase I to estimate RP2D. If RP2D is estimated, we will continue enrollment as planned into Phase II, if not, we will submit amendment with updated dosing
- Following the Phase I, the first 9 participants from each pair of Cohorts (1a+2a) and (1b+2b) enrolled at the RP2D of palbociclib and sasanlimab in Phase I and Phase II will be evaluated separately for response. If among these 9 participants from pair of Cohorts (1a+2a) and (1b+2b), no more than 1 objective response defined as CR+PR is seen, then no further participants will be enrolled in Cohort 2a or 2b
- Being tested
- Sasanlimab, Palbocicilib
- Keywords
- Papillary Renal Cell Carcinoma, Kidney Neoplasms, Kidney Cancer, Clear Cell Renal Cell Carcinoma, Translocation Renal Cell Carcinoma, TFE3-rearranged renal cell cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SasanlimabDrug
Sasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2).
PalbocicilibDrug
Palbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1.
| Study group | Role | What they receive |
|---|---|---|
| 1/ Phase I | Experimental | Sasanlimab and deescalating doses of palbociclib Receives: Drug: Sasanlimab; Drug: Palbocicilib |
| 2/Phase II | Experimental | Sasanlimab and palbociclib at the dose determined in Phase I (RP2D) Receives: Drug: Sasanlimab; Drug: Palbocicilib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: To determine RP2D of palbociclib in combination with sasanlimab
Number of DLTs within DLT period
Measured: 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
Measured: 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
DCR as assessed by 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
Measured: 6 years
progression-free survival (PFS)
Progression free survival determined by 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
Measured: 6 years
safety of the combination of palbociclib and sasanlimab
Any toxicities identified between Day 1 of Cycle 1 through 90 days after the study agent (s) was/were last administered will be collected and reported by type and grade. Beyond 90 days after the last intervention, only adverse events which are serious and related to the study intervention will be recorded and reported. Note: during re-treatment AEs will be documented from the re-start of the study intervention through 90 days after the study agent (s) was/were last administered. Beyond 90 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded
Measured: 6 years
overall survival (OS)
Participants assessed at Day 1 of every cycle, safety follow up visits at days 30, 60, 90, every 12 weeks until progression and/or every 6 months after progression for 6 years after enrollment.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Apr 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Clear Cell Renal Carcinoma (Ccrcc)Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ramaprasad Srinivasan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665361
- Sponsor's protocol ID
- 10000666
- Other IDs
- 000666-C
- Status last verified
- 13 Oct 2026
- First submitted
- 23 Dec 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05665361
- Acronym / sponsor ID
- 10000666
- Keywords
- Papillary Renal Cell Carcinoma, Kidney Neoplasms, Kidney Cancer, Clear Cell Renal Cell Carcinoma, Translocation Renal Cell Carcinoma, TFE3-rearranged renal cell cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Kidney cancer is the 8th most common malignancy and 12th leading cause of cancer-related death in the United States. It is estimated that there will be 79,000 new cases of kidney cancer diagnosed in 2022, resulting in 13,920 deaths. Despite a steady increase in the incidence of renal cell cancer (RCC) over the past 3 decades, there has been an improvement in observed 5-year survival rates.
- Most patients with advanced clear cell RCC are treated with immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD-1) and/or the CTLA4 axis and agents targeting the vascular endothelial growth factor (VEGF) pathway. There is a paucity of options for patients who have progressed on these therapies. There is currently no widely accepted standard for patients with papillary RCC, although some patients may benefit from agents such as cabozantinib or the combination of bevacizumab and erlotinib.
- Preclinical data suggest that inhibitors of CDK 4/6 might be active in kidney cancer and that these agents might act synergistically with PD-1 checkpoint inhibitors in a variety of preclinical models.
- Palbociclib is a highly selective, reversible oral inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Inhibition of CDK 4/6 blocks DNA synthesis by prohibiting the progression of the cell cycle from G1 to the S phase. Data from nonclinical studies indicate that palbociclib may have cytostatic effects on tumor cells.
- Sasanlimab is an investigational humanized immunoglobulin G4 monoclonal antibody that binds PD-1 and blocks its interaction with its ligands, programmed death-ligand 1 and 2 (PD-L1) \& (PD-L2). It presents the distinct characteristic that it can be administered subcutaneously on a monthly basis whereas approved and other available anti-PD-1/PDL1 therapies currently are administered intravenously. In animal models, it demonstrated high-affinity interaction with PD 1 and was associated with a significant delay in the growth of murine MC-38 colorectal tumors implanted in hu-PD-1 knock-in mice.
Objectives:
- Phase I: To determine recommended phase II dose (RP2D) of palbociclib in combination with sasanlimab
- Phase II: To determine the overall response rate (ORR) defined as partial response (PR) + complete response (CR) of the RP2D of the combination of palbociclib and sasanlimab in participants with advanced ccRCC (Cohorts 1a and 2a) and advanced pRCC (Cohorts 1b and 2b) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Eligibility:
- Age 18 years or older
- Participants with histologically or cytologically confirmed advanced ccRCC or pRCC
- Participants must have measurable disease per RECIST 1.1
- ECOG performance status <= 1
- Adequate organ function as defined by the liver, kidney, and hematologic laboratory testing
- Participants with ccRCC 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 can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC.
- No more than four prior lines of therapy in the metastatic setting.
Design:
- The proposed study is an open label, phase I/II study of palbociclib in combination with sasanlimab
- Participants will be enrolled simultaneously into Cohort 1a (ccRCC) and Cohort 1b (pRCC) and start treatment in cycles consisting of 28 (+/- 5) days
- Initially, 6-18 participants from Cohort 1a and/or Cohort 1b will be enrolled into Phase I to estimate RP2D. If RP2D is estimated, we will continue enrollment as planned into Phase II, if not, we will submit amendment with updated dosing
- Following the Phase I, the first 9 participants from each pair of Cohorts (1a+2a) and (1b+2b) enrolled at the RP2D of palbociclib and sasanlimab in Phase I and Phase II will be evaluated separately for response. If among these 9 participants from pair of Cohorts (1a+2a) and (1b+2b), no more than 1 objective response defined as CR+PR is seen, then no further participants will be enrolled in Cohort 2a or 2b
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/ Phase I | Experimental | Drug: Sasanlimab, Drug: PalbocicilibSasanlimab and deescalating doses of palbociclib |
| 2/Phase II | Experimental | Drug: Sasanlimab, Drug: PalbocicilibSasanlimab and palbociclib at the dose determined in Phase I (RP2D) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SasanlimabSasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2). | Drug | 1/ Phase I, 2/Phase II |
| PalbocicilibPalbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1. | Drug | 1/ Phase I, 2/Phase II |
Primary outcome
Phase I: To determine RP2D of palbociclib in combination with sasanlimab
Time frame: 28 days
Number of DLTs within DLT period
Phase II: Objective response rate (ORR)
Time frame: 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
4 secondary outcomes
Disease Control Rate (DCR) defined as PR + CR+ SD in participants re-treated with the study drug combination by RECIST 1.1
Time frame: 6 years
progression-free survival (PFS)
Time frame: 6 years
safety of the combination of palbociclib and sasanlimab
Time frame: 6 years
overall survival (OS)
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramaprasad Srinivasan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sasanlimab and Palbocicilib in people with Advanced Clear Cell Renal Carcinoma (Ccrcc) and Papillary Renal Cell Carcinoma (Prcc), run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanda A Bell-Farrell ((240) 858-7768, wanda.bell-farrell@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: To determine RP2D of palbociclib in combination with sasanlimab (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.