John Sfakianos
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.
Inclusion Criteria: 1. Age ≥18 years at the time of consent. 2. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Able and willing to provide written informed consent. 3. Eastern Cooperative Oncology Group scores ≤ 1 within 28 days prior to registration. 4. Non-muscle-invasive bladder cancer * Cohort A: CIS +/- high grade papillary urothelial cancer (Ta or T1) after 3-mo evaluation after induction BCG. * Cohort B: High grade papillary urothelial cancer (Ta or T1…
Durvalumab 1500mg IV
Monalizumab 1500mg IV