A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Sfakianos
About this trial
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.
Eligibility criteria
Qualifiers
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 examinations including follow up. Able and willing to provide written informed consent.
Eastern Cooperative Oncology Group scores ≤ 1 within 28 days prior to registration.
Non-muscle-invasive bladder cancer
Disqualifiers
Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Prior CIS of the ureters or prostatic urethra within 24 months prior to registration.
Evidence of metastatic disease on imaging (CT or MRI) of the abdomen and pelvis within 90 days of registration.
Body weight ≤ 30 kg.
Trial design
Treatments tested in this trial
- Durvalumab
- Monalizumab
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
John Sfakianos
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
AstraZeneca
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Bladder Cancer Advocacy Network
Collaborator
Source ClinicalTrials.gov