Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer

This study, called REINFORCE, is looking at a new treatment approach for advanced bladder cancer that has responded well to initial treatment with enfortumab vedotin and pembrolizumab. This initial combination has improved outcomes, but many patients still have some cancer left. The study aims to see if additional treatments, like radiation therapy (IMRT or VMAT) with radiosensitizing chemotherapy, or surgery (radical cystectomy and pelvic lymphadenectomy), can help manage this remaining cancer. This is a pilot study to see if this treatment strategy is practical and safe. You might be able to join if you are 18 or older, have muscle-invasive bladder cancer (Stage III or IV), and your cancer has responded to initial treatment. The main goal is to see how many patients complete the planned treatment within 12 months.

Study design: This is a single-arm study, meaning all participants receive the same treatment plan. It is a pilot feasibility study with a planned enrollment of 12 participants.
What's involved: You would receive radiation therapy to the bladder and/or pelvis, possibly with radiosensitizing chemotherapy, or undergo surgery. The radiation therapy involves daily sessions for 20 fractions over 4 weeks.
Compensation: Not stated in the trial record.
Follow-up: The study measures the completion rate of treatment at 12 months after you are determined eligible.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial

Recruiting

PHASE1Ages 18+InterventionalTreatment

University of Washington

~12 participants

Updated 2026-08-25 on ClinicalTrials.gov

What's tested:Intensity-Modulated Radiation TherapyVolume Modulated Arc TherapyRadiosensitizing AgentRadical CystectomyPelvic LymphadenectomyStereotactic Body Radiation Therapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Completion rate of protocol-defined treatment (feasibility)

Measured over 12 months since eligibility determination

Conditions

Muscle Invasive Bladder Carcinoma

Stage III Bladder Cancer AJCC v8

Stage IV Bladder Cancer AJCC v8

NCT07579195

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washingtonstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

T. Martin Ma, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

T. Martin Ma, MD, PhD

[email protected]

206-606-7318

Email the study team

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Eligibility criteria

Inclusion

Age \>= 18 at the time of screening

Ability to understand and willingness to sign a written informed consent document

Histopathologically confirmed cTxN1-3M0, cTxNxM1 or cT4bNxM0 muscle invasive bladder cancer at initial diagnosis

Achieved a radiographic complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria and at the determination of treating physicians) after 3-9 cycles of induction EV + pembro

If M1 after completion of EV + pembro, patients need to have =\< 5 sites of metastasis and all sites of metastasis should be extracranial

Note: when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastatic lesions, etc). Five or fewer sites of metastasis applies after the completion of EV + pembro, not at initial diagnosis

Be a candidate for consolidative radiation therapy (RT) to the pelvis (if indicated) or cystectomy (if indicated), and all sites of metastasis are amenable to RT

Life expectancy \> 6 months

Eastern Cooperative Oncology Group (ECOG) performance 0-2

Absolute neutrophil count (ANC) \>= 1500 /mcL (within 180 days of trial registration)

Platelets \>= 100,000/mcL (within 180 days of trial registration)

Hemoglobin \> 9 g/dL (within 180 days of trial registration)

Creatinine =\< 1.5 x upper limit of normal (ULN) OR \>= 60 mL/min (within 180 days of trial registration)

Total bilirubin =\< 1.5 ULN OR direct bilirubin =\< ULN if total bilirubin \> 1.5 x ULN (within 180 days of trial registration)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN OR \< 5 x ULN if patient has live metastasis (within 180 days of trial registration)

Albumin \>= 2.5 g/dL (within 180 days of trial registration)

International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range (within 180 days of trial registration)

PTT =\< 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range (within 180 days of trial registration)

Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception during, and for at least 90 days after the end of radiation therapy. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of treatment initiation

HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial

Exclusion

Prior radiation therapy with field overlapping with current proposed radiation field, precluding delivery of meaningful dose of radiation

Intracranial metastasis

Any small cell component, or predominant (\> 50%) sarcomatoid or plasmacytoid histology

Other active malignancy or clinically relevant malignancy within past 2 years, per discussion with the principal investigator

Genetic conditions that increase sensitivity to radiation, such as Fanconi syndrome, ataxia telangiectasia, and Nijmegen breakage syndrome

Active human immunodeficiency virus (HIV) not adequately controlled, active hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected), as determined by standard of care testing

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Any other medical condition that may interfere with trial therapy delivery

Adults with impaired decision-making capacity, as determined by the treating physician

What this trial measures

Completion rate of protocol-defined treatment (feasibility)12 months since eligibility determination
Feasibility will be assessed through the completion rate of protocol-defined treatment. Primary endpoint is met if the completion rate of protocol-defined treatment is \> 70%. Descriptive statistics will be provided.

Trialytics