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Bladder Urothelial CarcinomaPhase 2NCT07414992

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

A Phase 2 study testing Stereotactic body radiotherapy, Cemiplimab and Cemiplimab and Fianlimab in people with Bladder Urothelial Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Urothelial Carcinoma
What is being tested?
Stereotactic body radiotherapy, Cemiplimab and Cemiplimab and Fianlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
7 sitesUnited States
Study dates
Sep 2026to Mar 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)
  • Grade 2 or above peripheral neuropathy (per CTCAE v5.0)
  • Availability of tumor specimen block or 20 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 20 slides available may be enrolled after discussion with the Principal Investigator.
  • Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist
  • Life expectancy ≥ 12 weeks at randomization
  • Required initial laboratory values:
  • Absolute neutrophil count ≥ 1.0 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Bilirubin ≤1.5 times the upper limit of normal (x ULN)
  • AST and ALT ≤ 3 x ULN
  • Partial thromboplastin time (PTT)/prothrombin time (PT) ≤1.5 x ULN or international normalized ratio (INR) < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.
  • For women of childbearing potential: agreement to remain abstinent (i.e., refrain from heterosexual intercourse) or use contraception, as defined below:
  • Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of < 1% per year during the treatment period plus 6 months after the last dose of cemiplimab with or without fianlimab.
  • Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices
  • A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
  • Male subjects must be willing to use contraception during the study and until 6 months after the last dose of study treatment.

Who cannot join

  • 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.
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  • 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.
  • Live vaccines are also prohibited during neoadjuvant therapy and for 90 days after completing neoadjuvant therapy.
  • Has had an allogenic tissue/solid organ transplant
  • Unstable angina.
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  • History of myocardial infarction within 6 months.
  • History of stroke within 6 months.
  • Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.
  • Major surgical procedure within 28 days prior to the study other than transurethral resection of bladder tumor.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Other prior malignancy active within the previous 2 years except for local or organ-confined early-stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.
  • Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
  • Notes:
  • Patients with known HIV who have controlled infection (undetectable viral and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
  • Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
  • Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
  • Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.
  • Participants with a history of myocarditis.
  • Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
  • TnT or Tnl levels between > 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN.
  • If TnT or Tnl levels are > 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the judgement in the patient's best interest.
  • Known hypersensitivity to the active substances or to any of the excipients.
  • WOCBP* must have a negative serum (beta-hCG) at screening.
  • WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance.
  • Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
  • Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.
  • Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment
  • All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose
  • Pregnant or breastfeeding women.
  • Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
  • stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
  • intrauterine device; intrauterine hormone-releasing system;
  • bilateral tubal occlusion/ligation;
  • vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
  • sexual abstinence
  • Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • Active infection requiring therapy.
  • Subjects who are compulsorily detained for treatment of a psychiatric illness.
  • History or current evidence of significant (CTCAE grade ≥ 2) local or systemic infection (e.g, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Stereotactic body radiotherapy, Cemiplimab, Cemiplimab and Fianlimab, Radical cystectomy
Keywords
Cemiplimab, Fianlimab, Bladder cancer, Muscle-invasive bladder cancer, Cystectomy, Radiotherapy, 25-328
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic body radiotherapyRadiation

    Stereotactic body radiotherapy (SBRT) Tumor-directed SBRT will be delivered in three once-daily 8 Gy fraction

  • CemiplimabDrug

    Cemiplimab will be delivered on day 1 of each cycle for a total of 4 cycles,

  • Cemiplimab and FianlimabDrug

    Within 96 hours (i.e., 4 days) of completing the 3rd SBRT treatment, patients will receive their first cycle of cemiplimab and fianlimab in the morning or early afternoon. Patients will receive a total of 4 cycles of cemiplimab and fianlimab with each cycle lasting 3 weeks and treatment occurring during weeks 0, 3, 6, and 9. Cemiplimab and fianlimab infusions in the morning or early afternoon will be encouraged.

  • Radical cystectomyProcedure or surgery

    Within 60 days of completing the 4 cycles of cemiplimab and fianlimab, patients will undergo radical cystectomy which is standard of care.

Study groups in NCT07414992
Study groupRoleWhat they receive
Radiation Therapy and CemiplimabExperimentalStereotactic body radiotherapy (SBRT) and cemiplimab
Receives: Radiation: Stereotactic body radiotherapy; Drug: Cemiplimab; Procedure: Radical cystectomy
Radiation Therapy and Cemiplimab With FianlimabExperimentalStereotactic body radiotherapy (SBRT) and cemiplimab with Fianlimab
Receives: Radiation: Stereotactic body radiotherapy; Drug: Cemiplimab and Fianlimab; Procedure: Radical cystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of pathologic downstaging

    Pathologic downstaging will be defined as lack of muscle invasive carcinoma (<ypT2) and the absence of lymph node metastasis (ypN0) in the final cystectomy specimen after radical cystectomy.

    Measured: 2 years

Secondary outcomes (1)

  1. Pathologic complete response

    Is defined as the absence of carcinoma (ypT0) and the absence of lymph node metastasis (ypN0) in the final cystectomy and regional lymph node specimens.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Why it stopped: The sponsor is no longer supporting the trial because they are no longer interested in studying the drug in the target patient population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Single-center, phase II study. Memorial Sloan Kettering Cancer Center 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.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07414992
Sponsor's protocol ID
25-328
Status last verified
Sep 2026
First submitted
11 Feb 2026
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic body radiotherapy, Cemiplimab and Cemiplimab and Fianlimab in people with Bladder Urothelial Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of pathologic downstaging (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07414992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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