Substudy 03C: Clinical Trial of Combination Therapies in RCC

• Research type

  Research Study

• Full title

  A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy

• IRAS ID

  1011101

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07049926

• Research summary

  Researchers are looking for new ways to treat people with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC). ccRCC is the most common type of kidney cancer. Locally advanced means cancer has spread into tissue near where it started. Metastatic means cancer has spread to other body parts.

  The main goals are to learn:
  • About the safety of certain combinations of study treatments and if people tolerate them
  • If the cancer responds (gets smaller or goes away) to the treatments

  About 100 people, aged 18 years and older, will be in this study and:
  • Had the cancer come back or get worse during or after they received certain treatments
  • Can give a tumour sample
  • Do not have certain health conditions

  People may take belzutifan and zanzalintinib, which are targeted therapies, by mouth daily. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.

  This study has 2 parts:
  • Part 1: First, researchers will test the safety of the study treatments in small groups of people. The groups will receive different dose levels (amounts) of certain study treatments. Researchers will check to see if there are any safety concerns.
  • Part 2: Everyone in the study will take the study treatments at the dose level found in Part 1 until the cancer grows or spreads or they do not tolerate it.
  During the study, people may have urine, blood, and imaging tests and have physical examinations such as tests to check their heart or to look for tumours. People may be in this study for up to 5 years.

  People may benefit because the study treatments may treat ccRCC or stop it from getting worse. There may be risks because the study treatments may not work or may cause health problems.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0147

• Date of REC Opinion

  2 Jul 2025

• REC opinion

  Further Information Favourable Opinion