Actively Recruiting
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-04
43
Participants Needed
8
Research Sites
102 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.
CONDITIONS
Official Title
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Ability to provide informed consent or have a legal representative provide consent
- Signed and dated IRB-approved informed consent form
- Histologically confirmed metastatic stage IV clear cell renal cell carcinoma or translocation-associated renal cell carcinoma
- Availability of archival tissue for diagnosis confirmation or documented confirmation from study PI
- At least one measurable lesion outside bones and brain as per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Received 2 to 3 prior systemic therapies including PD-1 or PD-L1 targeted treatment and VEGFR directed TKI therapy
- Recovered to baseline or less than Grade 1 toxicity from prior treatments unless stable on supportive therapy
- Completed and recovered from radiotherapy effects with at least 14 days washout before registration
- Ability to swallow oral medications
- Adequate blood counts and organ function per specified lab values within 14 days before first treatment
- Women of childbearing potential must not be pregnant or lactating and must agree to use two effective contraception methods during and 4 months after treatment
- Sexually active participants must use medically accepted contraception methods during and 4 months after treatment
- Male patients must agree not to donate sperm and female patients must agree not to donate eggs during study and 4 months after last dose
You will not qualify if you...
- Prior treatment with abemaciclib or cabozantinib
- Receipt of anti-cancer therapies or investigational agents within specified washout periods before treatment
- Symptomatic brain metastasis or leptomeningeal disease requiring steroids; neurologically unstable within 4 weeks
- Diagnosis of another malignancy within 2 years except certain early stage or skin cancers
- Use of moderate or strong CYP3A4 inducers or inhibitors
- Uncontrolled HIV infection or active hepatitis B or C infection
- Active systemic bacterial or fungal infections requiring antibiotics
- Significant cardiovascular events or unstable heart conditions within 6 months
- Uncontrolled high blood pressure despite treatment
- Significant arterial disease within 6 months
- Prolonged corrected QT interval on ECG
- Use of certain anticoagulants except specified allowed medications
- Recent significant bleeding or bleeding disorders
- Cavitating pulmonary lesions or endobronchial disease
- Uncontrolled pleural, pericardial effusions, or ascites needing frequent drainage
- Major surgery within 6 weeks before treatment with incomplete healing
- Evidence of tumor invading gastrointestinal tract or active gastrointestinal diseases
- History of abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Tumor invading or encasing major blood vessels except renal vessels ipsilateral to tumor
- Malabsorption syndrome
- Serious non-healing wounds, ulcers, or bone fractures
- Active COVID-19 infection unless recovered for at least 30 days
- Allergy or hypersensitivity to study drugs
- Recent radiation therapy for bone metastasis or systemic radionuclide treatments with ongoing complications
- Serious uncontrolled medical conditions as judged by investigator including interstitial lung disease or severe diarrhea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Johns Hopkins University (Data Collection Only)
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Sahil Doshi, MD
CONTACT
M
Martin Voss, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here