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Monoclonal Antibodies

Combination Therapy for Bladder Cancer (NeoSTOP-IT Trial)

Phase 2

Waitlist Available

Led By Alexander Z Wei, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years of age on day of signing informed consent

Histologically confirmed muscle-invasive urothelial carcinoma of the bladder defined as T2-T3, N0, M0 stage. Mixed histology is permitted if there is a urothelial component. Upper tract disease is not permitted

Must not have

Received bladder-directed radiation therapy previously for bladder cancer

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a combination of gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and c

Who is the study for?

Adults with localized muscle-invasive bladder cancer who can undergo tumor removal and chemotherapy. Participants must be able to receive cisplatin, have no prior treatments for their condition, and not have any autoimmune diseases or conditions that could interfere with the study.

What is being tested?

The trial is testing if adding cemiplimab (an immune therapy) to standard chemo (gemcitabine/cisplatin) improves treatment outcomes in bladder cancer, with some patients also receiving fianlimab. It's a randomized study where participants are chosen by chance for different treatment combinations.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as skin rash or thyroid issues, typical chemo-related effects like nausea and hair loss, fatigue, potential organ inflammation, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My bladder cancer is invasive but hasn't spread beyond my bladder.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I had bladder cancer treatment but finished it over 6 weeks ago.

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My cancer has not spread to other parts of my body according to scans.

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I haven't had chemotherapy or immunotherapy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy for bladder cancer before.

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I am currently being treated for an infection.

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I have previously received treatments like immunotherapy or cellular therapy.

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I have had chemotherapy for bladder cancer that has grown into the muscle.

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I haven't had a serious infection needing antibiotics in the last 2 weeks.

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I have had an organ or bone marrow transplant.

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I have had myocarditis in the past.

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I have another active cancer besides non-melanoma skin cancer.

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I have a history of lung disease not caused by infections.

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I do not have an uncontrolled HIV, HBV, or HCV infection or a related immunodeficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Complete Response

Secondary study objectives

Bladder-intact survival

Number of Adverse Events

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2: Gemcitabine/Cisplatin/Cemiplimab/FianlimabExperimental Treatment4 Interventions

* Gemcitabine 1000 mg/m2 IV (days 1 and 8 of 21 day cycle for 4 cycles) * Cisplatin 70 mg/m2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose cisplatin 35 m/m2 IV (day 1 and 8 of 21 day cycle for 4 cycles ) * Cemiplimab (REGN 2810) 350mg IV every 3 weeks (4 cycles) * Fianlimab (REGN3767) 1600mg IV every 3 weeks (4 cycles)

Group II: Group 1: Gemcitabine/Cisplatin/CemiplimabExperimental Treatment3 Interventions

* Gemcitabine 1000 mg/m\^2 IV (days 1 and 8 of 21 day for 4 cycles) * Cisplatin 70 mg/m\^2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose -cisplatin 35 m/m\^2 IV (day 1 and 8 of 21 day cycle for 4 cycles) * Cemiplimab (REGN 2810) 350 mg IV every 3 weeks (17 cycles)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Cisplatin

2013

Completed Phase 3

~3120