Abemaciclib + MK-6482 for Renal Cell Carcinoma

Recruiting at 1 trial location

Overseen By Toni K Choueiri, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: CDK4/6 inhibitors, HIF-2α inhibitors

Disqualifiers: Investigational agents, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 8

Duration: 12-18 months

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Toni Choueiri, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with advanced or metastatic renal cell carcinoma that has a clear cell component. Participants must have previously tried and not responded well to at least one anti-VEGFR therapy and an immune checkpoint inhibitor. They should be in relatively good health, able to take oral medication, and willing to use contraception.

Inclusion Criteria

You need to have at least 100,000 platelets per microliter of blood.

You have a disease that can be measured using a specific medical guideline.

My organ and bone marrow functions are normal.

Exclusion Criteria

I have previously been treated with a HIF-2α inhibitor.

Participants who have taken herbal medications and certain fruits within 7 days prior to starting study drug

I am willing and able to follow the study rules.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib alone or in combination with MK-6482 for 12 to 18 months

12-18 months

Imaging assessments every 8 weeks during the first six months, then every 12 weeks

Safety Follow-up

Participants undergo safety follow-up visits after completing treatment

3 months

Long-term Follow-up

Participants are monitored for overall survival and health status every 6 months

Long-term

Treatment Details

Interventions

• Abemaciclib
• MK-6482

Trial Overview The study is testing the safety and effectiveness of two drugs, Abemaciclib alone or combined with MK-6482, in slowing down the growth of clear cell renal cell carcinoma (ccRCC). It will involve patients who meet specific health criteria.

Participant Groups

Group I: Abemaciclib-Arm 1 Experimental Treatment 1 Intervention

Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks, in both Arm 1 and Arm 2.

Group II: Abemaciclib and MK-6482-Arm 2 Experimental Treatment 2 Interventions

Arm 2 * Arm 2 will start enrolling only after there is experience with Arm 1 to see what abemaciclib effects are when given alone, * Dose escalation will occur following a 3+3 design. * Abemaciclib will be taken 2X daily uring 28 day study cycle * MK-6482 will be taken 1x daily during 28 day study cycle * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks, in both arms.

Abemaciclib is already approved in United States, European Union for the following indications:

Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University