NCT04627064

ABEMA Alone or in COMBO With MK-6482

A Phase I/IB Trial of Abemaciclib Alone or in Combination With MK-6482 in Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study will assess whether abemaciclib alone or in combination with MK-6482 are safe and effective in slowing down the growth of clear cell renal cell carcinoma (ccRCC). The names of the study drugs in this investigational combination are: * Abemaciclib * MK-6482

Detailed description

This a two-arm, non-randomized phase 1/1B trial aiming at assessing the safety and activity of abemaciclib alone (arm 1), and abemaciclib plus MK-6482 (arm 2) in patients with advanced refractory clear-cell renal cell carcinoma (croc). A Phase I clinical trial tests the safety of an investigational drug or drug combination and also tries to define the appropriate dose of the investigational drug or drug combination to use for further studies. "Investigational" means that the drug is being studied.The U.S. Food and Drug Administration (FDA) has not approved either abemaciclib or MK-6482 for renal (kidney) cancer but abemaciclib has been approved to treat other forms of cancer. Abemaciclib is in a class of drugs known as CDK4 \& 6 inhibitors. These proteins control how fast cells grow and divide and are found on both normal and cancer cells. They become overactive in cancer cells causing cells to grow and divide uncontrollably. Abemaciclib blocks these proteins just as the cells start to grow and divide and in other cancers has been shown to slow down cancer cell growth and division, causing cancer cells to become inactive or even die. MK-6482 is an oral, first-in-class selective small-molecule inhibitor that targets hypoxia-inducible factor (HIF)-2a, which promotes the growth of new vessels that fuel kidney cancer. This study is looking at two different treatments: * Arm 1 - abemaciclib alone: * To determine the response rate of abemaciclib alone in patients with advanced ccRCC * Arm 2 - combination therapy of abemaciclib and MK-6482 * To determine the maximum dose of abemaciclib and MK-6482 in combination. * To determine the response rate of abemaciclib and MK-6482 in patients with advanced ccRCC. The research study procedures include screening for eligibility, study treatment, participant evaluations and safety follow-up visits, in addition to general health status follow-up after study treatment. It is estimated that participants will receive 12 to 18 months of study treatment and 3 months of safety follow-up, totaling about 15 to 21 months from the start of study treatment. After the safety follow-up visits, the study doctor may request that participants return to clinic for additional tumor assessments or his/her staff will contact participants about every 6 months to follow their health status and find out about any anticancer treatments participants may have begun after study treatment. It is expected that about 40 people will take part in this research study. The pharmaceutical company Eli Lilly is supporting this research study by providing funding for the research study, tests required for research purposes only, and the study drugs. The pharmaceutical company Merck is supporting this research study by providing study drug.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Tablet taken orally
DRUG	MK-6482	Tablet taken orally

Timeline

• Start date: 2020-12-31
• Primary completion: 2024-02-09
• Completion: 2024-08-04
• First posted: 2020-11-13
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study