RecruitingPhase 1Phase 2NCT06835972

A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)

A Phase 1b/2 Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

43 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Renal Cell Carcinoma Translocation Renal Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of abemaciclib (a drug that blocks cancer cell division) and cabozantinib (a drug that cuts off tumor blood supply) for people with advanced kidney cancer — specifically clear cell renal cell carcinoma — that has not been cured by surgery. **You may be eligible if...** - You are 18 or older - You have been confirmed to have metastatic (Stage IV) clear cell renal cell carcinoma or a related translocation-associated renal cell carcinoma - Tumor tissue is available from a prior surgery or biopsy - You are able to take oral medications - You have adequate organ function **You may NOT be eligible if...** - You have a different subtype of kidney cancer - You have uncontrolled brain metastases - You have significant cardiovascular, liver, or kidney problems - You are pregnant or breastfeeding - You have had recent serious bleeding events Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

twice a day, orally

DRUGCabozantinib

once daily, orally

Locations(8)

Johns Hopkins University (Data Collection Only)

Baltimore, Maryland, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06835972

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