A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

Trial Details

NCT ID
NCT06503614
Phase
PHASE2
Sponsor
John Sfakianos
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Durvalumab
  • Monalizumab
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • New Brunswick, New Jersey, United States|40.48622,-74.45182
  • New York, New York, United States|40.71427,-74.00597
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Age ≥18 years at the time of consent.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and exami…
  • Eastern Cooperative Oncology Group scores ≤ 1 within 28 days prior to registration.
  • Non-muscle-invasive bladder cancer

For full eligibility, visit ClinicalTrials.gov.

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