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A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer | Clinical Trials | Clareo Health

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A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer

Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)

NCT07414992•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The researchers are doing this study to find out whether stereotactic body radiation therapy (SBRT) in combination with immunotherapy (cemiplimab with or without fianlimab) before cystectomy is an effective and safe treatment for people with muscle-invasive bladder cancer (MIBC).

Detailed Description

Patients will be assigned to neoadjuvant SBRT and cemiplimab (Cohort 1) until Cohort 1 completes accrual and then enrollment for Cohort 2 will begin with those patients receiving neoadjuvant SBRT plus cemiplimab and fianlimab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at the time of informed consent
•ECOG 0-1
•Histologically confirmed diagnosis of urothelial carcinoma.
•° Variant histology is acceptable if there is a predominant urothelial component. Any neuroendocrine / small cell components are excluded (Investigators are encouraged to discuss with study team and PI)
•Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease per American Joint Committee on Cancer Staging Manual, 8th edition.
•* Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.
•* Clinically node-negative pelvis (cN0) on CT or MRI within 56 days: no pelvic lymph node ≥15 mm short-axis. Pelvic nodes 10-14 mm are permitted if not suspicious by GU radiology morphology; if deemed suspicious, biopsy or repeat imaging in 4-6 weeks must confirm cN0 prior to enrollment. PET may inform adjudication but is not required.
•Patients declines cisplatin-based therapy or is ineligible for cisplatin-based therapy based on any of the following criteria:
•* Estimated or calculated creatinine clearance ≥ 30ml/min but \< 60 ml/min
•* Grade 2 or above audiometric hearing loss (per CTCAE v5.0)
+16 more criteria

Exclusion Criteria

•Evidence of metastatic disease on standard staging CT and/or MR imaging
•Evidence of nodal metastasis (cN+), defined as any pelvic node ≥15 mm short-axis on CT/MRI or biopsy-proven nodal disease of any size.
•Prior systemic chemotherapy or non-BCG immunotherapy (e.g., T cell co-stimulation or targeting of immune checkpoint pathways with anti-PD-1, anti-PD-L1, anti-LAG-3, anti-PD-L2, anti-CTLA-4, anti-CD137, IL-15 superagonist, or other medicines specifically targeting T cells other than prior IL-2 therapy) for the treatment of bladder cancer
•Prior therapy with intravesical BCG within 6 weeks of treatment.
•Prior pelvic RT
•Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
•Patients using immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study. It is recommended that patients do not receive systemic corticosteroids such as hydrocortisone, prednisone, prednisolone (Solu-Medrol®) or dexamethasone (Decadron®) at any time throughout the study except in the case of a life-threatening emergency and/or to treat an immune-mediated adverse event.
•°Immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement must be discontinued within 14 days of initiating neoadjuvant SBRT.
•Received a live vaccine within 30 days of planned start of study medication.
•* Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.
+42 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Bladder Urothelial Carcinoma

Interventions

Stereotactic body radiotherapy

RADIATION

Cemiplimab

DRUG

Cemiplimab and Fianlimab

DRUG

Radical cystectomy

PROCEDURE

Contacts

Daniel Gorovets, MD

CONTACT

212-639-3983 gorovetd@mskcc.org

Matthew Mcmillan, MD

CONTACT

631-212-6399

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

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Muscle Invasive Bladder Urothelial CarcinomaMuscle Invasive Renal Pelvis Urothelial Carcinoma+5 more

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Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study

Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy