Oncology / Haematology

A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer

Trial Name: KEYNOTE-866  PI: Dr Babak Tamjid

Who can take part:

  • Patients with histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4a) with predominant (≥50%) urothelial histology.
  • Patients with clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT chest and CT or MRI of the abdomen/pelvis).
  • Patients who intend to undergo RC and PLND as definitive surgical treatment (curative intent) for MIBC.
  • Patients who have a newly obtained transurethral resection (TUR) of a bladder tumor (obtained within 60 days prior to study enrolment) which is evaluable for PD-L1 expression.

Exclusion criteria:

  • Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3years of study randomization
  • Has received any prior systemic anti-neoplastic treatment for MIBC.

For further information please contact Judy Reilly – 03 9784 8520

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4