A Phase 1b/2 Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma
Memorial Sloan Kettering Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years at the time of informed consent * 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 * Signed and dated IRB-approved Informed Consent Form * Patient must have a histologically confirmed diagnosis of metastatic stage IV clear cell renal cell carcinoma or metastatic stage IV translocation-associated renal cell carcinoma. * Patient should have availability of archival tissue that enables definitive diagnosis of ccRCC or tRCC, per review at partici…
Interventions
- DrugAbemaciclib
twice a day, orally
- DrugCabozantinib
once daily, orally
Locations (8)
- Johns Hopkins University (Data Collection Only)Baltimore, Maryland
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering West Harrison (Limited Protocol Activities)Harrison, New York