Actively Recruiting
A Phase 1b/2 Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-04
43
Participants Needed
8
Research Sites
N/A
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
Researchers are investigating whether combining the drugs 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) who have progressed after prior therapies. This phase 1b/2 clinical trial includes patients whose cancer has not responded to previous treatments, aiming to find the highest doses of these drugs that cause only mild or manageable side effects. The study is led by Memorial Sloan Kettering Cancer Center and focuses on patients with advanced kidney cancer who have received immune checkpoint inhibitors and other therapies. The trial consists of two parts: a dose escalation phase to determine the maximum tolerated doses of abemaciclib and cabozantinib, followed by a dose expansion phase to further evaluate these doses. Participants receive abemaciclib orally twice daily and cabozantinib orally once daily. The study is open-label, meaning both researchers and participants know what treatments are given. Eligible patients must have measurable metastatic lesions and have recovered from prior treatments before starting this combination therapy. During the study, participants undergo regular assessments including laboratory tests to check blood counts and organ function, imaging to measure tumor response, and monitoring for side effects. The primary outcome in the phase 1b part is the maximum tolerated dose over one year, while the phase 2 part focuses on the objective response rate within one year. The total participation includes careful follow-up to evaluate treatment effects and safety, and participants must be able to take oral medications throughout the trial period.
CONDITIONS
Brief 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 authorized 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 the study principal investigator
- At least one extra-skeletal, extracranial measurable lesion as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Received prior therapy with at least 2 and up to 3 systemic agents including prior PD-1 or PD-L1 targeted treatment and VEGFR targeted therapy
- Recovery to baseline or less than Grade 1 toxicity from prior treatments unless stable on supportive therapy
- Completed and recovered from acute effects of any prior radiotherapy with a washout of at least 14 days
- Ability to swallow oral medications
- Adequate hematologic and organ function based on laboratory criteria within 14 days before first treatment
- Women of childbearing potential must not be pregnant or lactating and must use two effective contraception methods during and for 4 months after treatment
- Sexually active participants must use medically accepted contraception methods during and for 4 months after treatment
You will not qualify if you...
- Prior treatment with abemaciclib or cabozantinib
- Receipt of anti-cancer antibody, cytotoxic therapy, or investigational agents within 2 weeks or 5 half-lives before treatment start; immune checkpoint inhibitors must be discontinued at least 28 days before enrollment
- Symptomatic brain metastasis or leptomeningeal disease requiring steroids, unless neurologically stable for 4 weeks and off steroids for 2 weeks
- Diagnosis of another malignancy within 2 years except certain skin or early stage cancers treated with curative intent
- Use of moderate or strong CYP3A4 inducers or inhibitors
- Uncontrolled HIV infection or active hepatitis B or C with detectable viral load
- Active systemic bacterial or fungal infection requiring antibiotics at treatment start
- Significant cardiovascular disease or recent major cardiovascular events
- Uncontrolled hypertension despite treatment
- Significant arterial disease within 6 months prior to treatment
- Prolonged QT interval greater than 470 ms on ECG
- Use of certain anticoagulants except specified allowed medications
- Clinically significant bleeding or bleeding disorders within 12 weeks prior to treatment
- Cavitating pulmonary lesions or endotracheal/endobronchial disease
- Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage
- Major surgery within 6 weeks before treatment without complete wound healing
- Evidence of tumor invading gastrointestinal tract or active gastrointestinal diseases
- Malabsorption syndrome or serious non-healing wounds
- Active COVID-19 infection unless recovered at least 30 days before treatment
- Allergy to study treatment components
- Recent radiation therapy for bone metastasis or systemic radionuclide treatment
- Serious uncontrolled medical conditions that would preclude study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive oral abemaciclib twice daily and oral cabozantinib once daily to treat metastatic clear cell renal cell carcinoma.
Regular visits for treatment monitoring and safety assessments
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
M
Martin Voss, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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