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Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

ConditionsBladder CancerMuscle-Invasive Bladder Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    Gemcitabine 1000 mg/m\^2 IV

  • Cisplatin

    Drug

    Cisplatin 70 mg/m\^2 IV or renally-dosed split-dose cisplatin 35 m/m\^2 IV

  • Cemiplimab

    Drug

    Cemiplimab 350mg IV

  • Fianlimab

    Drug

    Fianlimab 1600mg IV

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Group 1: Gemcitabine/Cisplatin/CemiplimabExperimental treatment 3 interventions
Group B: Group 2: Gemcitabine/Cisplatin/Cemiplimab/FianlimabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Clinical Complete Response

Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as: * No high-grade malignancy on repeat TURBT * No malignant cells on urine cytology * No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast) Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy.

Time frame
16 weeks

Secondary outcomes

1

Number of Adverse Events

Defined as the occurrence of any adverse event (AE) related to the investigational drugs at any point on treatment until 30 days after the last dose of treatment. AEs as evaluated per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
30 days after last dose of treatment, up to 56 weeks
2

Bladder-intact survival

Bladder-intact survival is defined as the time from start of treatment until cystectomy or death.

Time frame
Up to 5 years
3

Recurrence-free survival

Recurrence-free survival is defined as the time from start of treatment until disease recurrence or death. Recurrence-survival will only be measured in patients who achieve a clinical complete response.

Time frame
Up to 5 years
4

Overall survival

Overall survival is defined as the time from start of treatment until death.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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