Palbociclib + Sasanlimab for Kidney Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: National Cancer Institute (NCI)
Must not be taking: CYP3A inhibitors, CYP3A inducers, Corticosteroids, Herbal supplements
Disqualifiers: Autoimmune disease, Hepatitis B, Lung disease, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial requires participants to stop taking medications that are strong inhibitors or inducers of CYP3A (a liver enzyme) at least 21 days before starting the study. Herbal supplements must also be stopped 14 days before the trial begins. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug combination Palbociclib and Sasanlimab for kidney cancer?
While there is no direct data on Palbociclib and Sasanlimab for kidney cancer, similar drug combinations involving immune checkpoint inhibitors and tyrosine kinase inhibitors have shown improved outcomes in kidney cancer, with better survival rates and disease control.
12345How is the drug combination of Palbociclib and Sasanlimab unique for kidney cancer?
The combination of Palbociclib and Sasanlimab is unique for kidney cancer as it involves a novel approach by combining a cell cycle inhibitor (Palbociclib) with an immunotherapy agent (Sasanlimab), potentially offering a new mechanism of action compared to existing treatments that primarily focus on targeting specific pathways like tyrosine kinase or mTOR.
23467Eligibility Criteria
Adults with advanced kidney cancer, either clear cell renal cell carcinoma (ccRCC) after checkpoint inhibitor therapy and possibly VEGF antagonist treatment, or papillary renal cell carcinoma (pRCC), which may be untreated. Participants need at least one measurable tumor lesion, good physical condition, adequate blood counts and organ function. They must agree to use effective contraception and not breastfeed during the trial.Inclusion Criteria
I am 18 years old or older.
Your kidneys and liver are working well, and you do not have certain viral infections. If you have brain metastasis, you must have completed treatment at least 4 weeks ago with no signs of progression.
My kidney cancer is confirmed as clear cell (ccRCC) or papillary (pRCC).
+7 more
Exclusion Criteria
I have had cancer other than kidney cancer in the last 2 years.
I have had a bone marrow or organ transplant in the past.
I have or had hepatitis B.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive palbociclib orally for 21 days and sasanlimab injection on the first day of each 28-day cycle, repeated for up to 2 years
Up to 2 years
Monthly visits for drug administration and monitoring
Follow-up
Participants have follow-up visits every month for 3 months after treatment ends, with imaging scans every 3 months
3 months
3 visits (in-person), imaging scans every 3 months
Long-term follow-up
Participants continue to have imaging scans every 3 months and are monitored for up to 6 years
Up to 6 years
Imaging scans every 3 months
Participant Groups
The trial is testing a combination of two drugs: Sasanlimab (an injection) given once each cycle, and Palbociclib (a pill) taken daily for 21 days in each 28-day cycle. The study aims to evaluate their effectiveness in treating kidney cancers over cycles lasting up to two years with follow-ups extending up to six years.
2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment2 Interventions
Sasanlimab and palbociclib at the dose determined in Phase I (RP2D)
Group II: 1/ Phase IExperimental Treatment2 Interventions
Sasanlimab and deescalating doses of palbociclib
Palbociclib is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Ibrance for:
- HR-positive, HER2-negative advanced or metastatic breast cancer
🇪🇺 Approved in European Union as Ibrance for:
- HR-positive, HER2-negative locally advanced or metastatic breast cancer
🇨🇦 Approved in Canada as Ibrance for:
- HR-positive, HER2-negative advanced or metastatic breast cancer
🇯🇵 Approved in Japan as Ibrance for:
- HR-positive, HER2-negative advanced or recurrent breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor
References
Pembrolizumab plus axitinib combination and the paradigm change in the treatment of advanced renal cell carcinoma. [2021]Sequential administration of single targeted agents has been challenged as the dominant treatment paradigm in patients with metastatic renal cell carcinoma by improved outcomes obtained with combination regimens based on immune checkpoint inhibitors. Most patients treated with sequential monotherapy eventually develop drug resistance and succumb to progressive disease, leading to the search for therapies that would overcome drug resistance and result in a more durable treatment response. Improved outcomes have been demonstrated in Phase III trials in comparison with sunitinib for the combinations of axitinib plus pembrolizumab, axitinib plus avelumab, bevacizumab plus atezolizumab and ipilimumab plus nivolumab. A statistically significant improvement of both progression-free and overall survival has been demonstrated for the axitinib plus pembrolizumab combination.
Targeted therapy of kidney cancer: keeping the art around the algorithms. [2017]Therapy for metastatic kidney cancer is actively evolving, particularly in the results of registration drug trials that have led to the approval of vascular endothelial growth factor pathway drugs such as sorafenib, sunitinib, pazopanib, bevacizumab, and axitinib, with focus on patients with good- or intermediate-risk criteria and clear cell histology. Mammalian target of rapamycin (mTOR) drugs such as everolimus and temsirolimus pivotal trials emphasize experiences in the setting of prior treatment or high-risk features. Interferon and interleukin 2 also are part of the treatment algorithms.
Persistence and compliance with pazopanib in patients with advanced renal cell carcinoma within a U.S. administrative claims database. [2023]Pazopanib is an oral tyrosine kinase inhibitor with demonstrated efficacy and tolerability in patients with advanced renal cell carcinoma (RCC).
Targeted therapies in metastatic renal cell carcinoma: overview of the past year. [2021]During the past half-decade, clinical trials have permitted major progress in treatment of metastatic renal cell carcinoma with the first generation of targeted therapies (bevacizumab, sunitinib, sorafenib, everolimus, and temsirolimus). New targeted agents such as axitinib, tivozanib, and dovitinib, all of which are tyrosine kinase inhibitors, have been developed in treatment of metastatic renal cell carcinoma. In the same time, more information regarding mechanism of disease and drug resistance shed light on new targets and new potent agents. We report an overview of the more relevant data published over the past year, which may modify the therapeutic landscape of kidney cancer in the near future.
The Therapeutic Landscape of Renal Cell Carcinoma: From the Dark Age to the Golden Age. [2022]Oncologic treatments for renal cell carcinoma (RCC) have undergone a major revolution in the past 2 decades, moving away from the pre-2004 Dark Age during which interleukin 2 and interferon-α were the only therapeutic options and induced treatment responses in only 5% to 10% of patients with metastatic disease. The development of anti-angiogenic tyrosine kinase inhibitors against vascular endothelial growth factor receptor 2 and inhibitors of mammalian target of rapamycin complex 1 in 2005 introduced the Modern Age with better overall and progression-free survival and a greater number of patients (30%-40%) responding to and (∼80%) benefiting from these targeted therapeutic agents. The coming of age of the immuno-oncology era with the use of immune checkpoint inhibitors (ICIs) have ushered us into the Golden Age of metastatic RCC care, in which combined administrations of two ICIs (anti-programmed cell death protein 1/programmed death-ligand 1 and anti-cytotoxic T-lymphocyte-associated protein 4 or one tyrosine kinase inhibitor plus one ICI (anti-programmed cell death protein 1/programmed death-ligand 1) have recast the treatment landscape of clear cell RCC, the most common RCC subtype, with an approximately 60% response rate and an approximately 90% disease control rate that further improves metastatic RCC survival. Exciting clinical trials are in the pipeline investigating complementary/synergistic molecular mechanisms, based on studies investigating the biology, pathology, and genomics of renal carcinoma and the respective treatment outcome. This will enable us to enter the Diamond Age of precision medicine in which a specific treatment can be tailored to the specific biological and pathologic circumstance of an individual kidney tumor to offer more effective yet less toxic therapy.
[Nivolumab (Anti-PD-1 antibody; ONO-4538/BMS-936558) in renal cancer]. [2018]The effect of the anti-PD-1 antibody, nivolumab (ONO-4538/BMS-936558) on advanced renal cancer is promising. The present manuscript summarizes the use of this new drug in immunotherapy for renal cancer.
Bromodomain-Containing Protein 4 (BRD4) Inhibition Sensitizes Palomid 529-Induced Anti-Renal Cell Carcinoma Cell Activity in Vitro and in Vivo. [2019]Mammalian target of rapamycin (mTOR) is a valuable treatment target of renal cell carcinoma (RCC). Palomid 529 is a novel mTORC1/2 dual inhibitor.