Clinical trial for Muscle Invasive Bladder Carcinoma
Official title Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial
ClinicalTrials.gov ID: NCT07579195
What this study is testing
What is Radiosensitizing Agent?
Radiosensitizing Agent is an investigational medicine, given as an once-daily, being studied as a potential treatment for muscle invasive bladder carcinoma.
Also referred to as Radiation Sensitizers, Radiation-Sensitizing Agents.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This pilot feasibility clinical trial is evaluating a novel treatment strategy for patients with advanced bladder cancer that is unresectable, has spread to nearby lymph nodes or a limited number of distant sites (oligometastatic disease), and has responded to initial treatment with enfortumab vedotin and pembrolizumab. Although this combination has significantly improved outcomes compared to traditional chemotherapy, many patients are left with residual cancer in the bladder or other sites, and there is currently no established standard approach for managing this remaining disease or determining the optimal duration of systemic therapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- If M1 after completion of EV + pembro, patients need to have =\< 5 sites of metastasis and all sites of metastasis should be extracranial
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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 =\ = 60 mL/min (within 180 days of trial registration)
- 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...
- 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...
- HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial
- 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]...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.