Oncology / Haematology

A Phase 3, Randomized, Double‐blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK‐3475) in Combination with Lenvatinib (E7080) Versus Pembrolizumab and Matching Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin‐ineligible Participants Whose Tumors Express PD‐L1 and in Any Platinum‐ineligible Participants

Trial Name: LEAP-011  PI: Dr Babak Tamjid

Who can take part:

  • Patients with histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
  • Have at least 1 measurable target lesion per RECIST 1.1
  • Have received no prior systemic chemotherapy for advanced or metastatic UC with the following exceptions:
    • Neoadjuvant platinum-based chemotherapy for treatment of muscle-invasive bladder cancer with recurrence >12 months from completion of the therapy is permitted.
    • Adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence >12 months from completion of the therapy, is permitted.


Exclusion criteria:

  • Patients with disease that is suitable for local therapy administered with curative intent (eg, chemotherapy and radiation for Stage 3 disease).
  • Patients with a tumour with any neuroendocrine or small cell component

For further information please contact Judy Reilly – 03 9784 8520

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4