Merck U03B: Targeted combination therapies for second line ccRCC patients (Renal Cell Cancer)

What is the Purpose of this Study?

If you choose to join the study, you will:
- Have physical exams
- Have blood draws
- Have imaging tests (CT/MRI, EKG, echocardiogram, bone scans)
- Receive a random assignment (fair chance) to 1 of 6 study groups

Each study group will take a different combination of the study drug(s). The 6 possible study drug combinations are:
- MK-1308A alone
- MK-4280A alone
- Pembrolizumab + MK-4830
- Pemborlizumab + MK-6482
- Lenvatinib + MK-6482
- Pembrolizumab + lenvatinib

This study is not blinded. That means both you and your doctor will know the group to which you are assigned and what study drug(s) you will take.
What is the Condition Being Studied?
Clear Cell Renal Cell Carcinoma (ccRCC)

Who Can Participate in this Study?

Adults ages 18+ who are diagnosed with ccRCC and:

- Have been treated with a VEGF-TK-inhibitor drug

- Have been treated with an anti-PD-(L)1 monoclonal antibody

- Did not adequately respond to these treatments

For more information about who can join this study, please contact the study team at 919-681-7460.

Age Group
Adults
Participating Institutions
Duke Cancer Center Cary
Duke University Health System
Duke Raleigh Hospital

What is Involved?

We are doing this study to find out what combinations of experimental and approved drugs may be safe and effective treatments for your cancer. The approved drugs used in this study are pembrolizumab and lenvatinib. The four experimental drugs used in this study are called MK-1308A, MK-4280A, MK-4830, and MK-6482. No combination of any of these drugs is approved for the treatment of ccRCC.

Study Details

Full Title
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in
Participants with RCC (KEYMAKER Substudy U03B)
Principal Investigator

Protocol Number
IRB:
PRO00107303

NCT:
NCT04626518
ClinicalTrials.gov
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