Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer?
Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab.
Participants will:
* Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles) * After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging * Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months * Participants without a complete clinical response will undergo cystectomy (bladder surgery).
Eligibility criteria
Qualifiers
Willing and able to provide written informed consent for the trial.
Age ≥18 years of age on day of signing informed consent.
Life expectancy > 12 months.
Performance status of 0-1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Disqualifiers
Concurrent upper urinary tract (i.e., ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible).
Received prior immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-LAG-3 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways ), as well as cellular vaccines, cellular therapies, or systemic oncolytic virus therapy.
Received bladder-directed radiation therapy previously for bladder cancer.
Received prior systemic chemotherapy for muscle-invasive bladder cancer.
Trial design
Treatments tested in this trial
- Gemcitabine
- Cisplatin
- Cemiplimab
- Fianlimab
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov