43 Participants Needed

Abemaciclib + Cabozantinib for Kidney Cancer

Recruiting at 7 trial locations
MV
RM
Overseen ByRobert Motzer, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot take certain medications like moderate or strong CYP3A4 inducers or inhibitors, and some anticoagulants. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug combination Abemaciclib and Cabozantinib for kidney cancer?

Cabozantinib has been shown to be effective in treating advanced kidney cancer, improving survival and response rates in patients, as seen in the METEOR trial. It is approved for use in advanced kidney cancer, which suggests it could be beneficial when combined with other treatments like Abemaciclib.12345

What safety information is available for cabozantinib in combination treatments?

Cabozantinib, when used in combination with other drugs like nivolumab, has a safety profile that is generally manageable with proper care. Common side effects include diarrhea, fatigue, and skin reactions, and they can often be managed with dose adjustments and supportive care.46789

What makes the drug combination of Abemaciclib and Cabozantinib unique for kidney cancer?

The combination of Abemaciclib and Cabozantinib is unique for kidney cancer because it combines two different mechanisms: Abemaciclib, a CDK4/6 inhibitor that blocks cancer cell division, and Cabozantinib, a tyrosine kinase inhibitor that targets multiple pathways involved in cancer growth and resistance. This dual approach may offer a novel way to tackle kidney cancer compared to existing treatments that typically focus on single pathways.1481011

What is the purpose of this trial?

The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.

Research Team

MV

Martin Voss, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with metastatic clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. Participants should not have had previous treatments that failed and must be in good physical condition to handle the study drugs.

Inclusion Criteria

Signed and dated IRB-approved Informed Consent Form
Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the patient cannot
I have been diagnosed with stage IV clear cell kidney cancer.
See 12 more

Exclusion Criteria

I have been treated with abemaciclib or cabozantinib before.
My blood pressure is not controlled by medication.
Previously identified allergy or hypersensitivity to components of the study treatment formulations
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of abemaciclib and cabozantinib to determine the maximally tolerated dose

Up to 1 year

Dose Expansion

Participants receive the determined dose of abemaciclib and cabozantinib to evaluate safety and effectiveness

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Abemaciclib and Cabozantinib
Trial Overview The study is testing the combination of two drugs, Abemaciclib and Cabozantinib, to see if they're safe and effective for treating ccRCC. Researchers will try different doses to find the most effective one with the least side effects.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Abemaciclib and CabozantinibExperimental Treatment2 Interventions
This is a two-site single-arm open-label phase 1b/2 clinical trial evaluating abemaciclib plus cabozantinib in patients with metastatic ccRCC that have progressed on therapy. The study comprises a dose escalation portion followed by a dose expansion phase 2 trial.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Findings from Research

Cabozantinib was designated as a breakthrough drug by the FDA and approved in 2016 for treating advanced clear cell renal cell carcinoma (ccRCC), which is the most common kidney cancer type, accounting for about 90% of cases.
The METEOR trial demonstrated significant efficacy for cabozantinib in advanced RCC, and ongoing studies like the CABOSUN trial will further clarify its effectiveness compared to other treatments like sunitinib.
Clinical use of cabozantinib in the treatment of advanced kidney cancer: efficacy, safety, and patient selection.Yu, SS., Quinn, DI., Dorff, TB.[2022]
Cabozantinib shows promising anti-tumor activity in patients with metastatic clear cell renal cell carcinoma (RCC), with a partial response observed in 28% of the 25 heavily pretreated participants.
The treatment demonstrated a median progression-free survival of 12.9 months and a median overall survival of 15.0 months, with a safety profile consistent with other similar therapies, indicating its potential as a viable option for advanced RCC patients.
A phase I study of cabozantinib (XL184) in patients with renal cell cancer.Choueiri, TK., Pal, SK., McDermott, DF., et al.[2021]
In a phase II trial involving 47 patients with advanced non-clear-cell renal cell carcinoma, the combination of cabozantinib and nivolumab showed a promising objective response rate of 47.5% in patients with papillary, unclassified, or translocation-associated RCC, along with a median progression-free survival of 12.5 months.
The treatment was less effective in chromophobe RCC, with no objective responses observed, highlighting the need for further research into genomic predictors of response, particularly mutations like NF2 and FH that were associated with better outcomes.
Phase II Trial of Cabozantinib Plus Nivolumab in Patients With Non-Clear-Cell Renal Cell Carcinoma and Genomic Correlates.Lee, CH., Voss, MH., Carlo, MI., et al.[2023]

References

Clinical use of cabozantinib in the treatment of advanced kidney cancer: efficacy, safety, and patient selection. [2022]
A phase I study of cabozantinib (XL184) in patients with renal cell cancer. [2021]
Phase II Trial of Cabozantinib Plus Nivolumab in Patients With Non-Clear-Cell Renal Cell Carcinoma and Genomic Correlates. [2023]
Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma. [2023]
Outcomes based on prior therapy in the phase 3 METEOR trial of cabozantinib versus everolimus in advanced renal cell carcinoma. [2021]
Management of adverse events associated with cabozantinib plus nivolumab in renal cell carcinoma: A review. [2023]
Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. [2022]
Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. [2022]
Adverse Events of Cabozantinib Plus Nivolumab Versus Ipilimumab Plus Nivolumab. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Cabozantinib as a novel therapy for renal cell carcinoma. [2022]
[Pharmacological properties and clinical outcomes of the anti-cancer drug, cabozantinib (CABOMETYX®)]. [2022]
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