Oncology / Haematology

An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After 1 Prior Anti-PD-1/L1 Combination Regimen

Trial Name: MK6482-011  PI: Dr Babak Tamjid

 

Who can take part:

  • Must have a histologically confirmed diagnosis of unresectable, locally advanced/metastatic RCC with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per AJCC (8th Edition). Previous nephrectomy or metastasectomy is allowed.
  • Has experienced disease progression on or after having received first-line systemic treatment for locally advanced or metastatic RCC with prior anti-PD-1/L1 + anti-CTLA4 combination or anti-PD-1/L1 + VEGF-targeted TKI combination.
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Has received no more than 1 prior systemic regimens for locally advanced or metastatic RCC.

Exclusion criteria:

  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has known CNS metastases and/or carcinomatous meningitis

For further information please contact Judi – 9784 8301

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4