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Treatment Of Metastatic Bladder cancer at the time Of biochemical reLApse following radical cystectomy - TOMBOLA
EU CTIS ID: 2024-510865-41-00
What this study is testing
Complete response (CR) after treatment with investigational agent initiated by ctDNA positive statusafter radical cystectomy (with or without concomitant visible metastases on CT). Data will becompared to available historical data on response to PD-1 / PD-L1 targeted agents14,15. CR in thecurrent study is defined as ctDNA negative status in the last plasma samples taken during IOtreatment combined with negative imaging (CT) at the same time point after treatment. Thus, anymetastasis visible on CT at the time of treatment initiation should undergo complete response. InStudy Subjects without visible metastasis on CT at the time of treatment, initiation should result inunchanged status on CT.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age at the time of signing the Informed Consent Form
- For male Study Subjects: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
- Signed Informed Consent Form
- ECOG PS 0 or 1
- Is, according to the Investigator’s judgement, able to comply with the trial protocol
- Ability to understand the Participant Information Sheet orally and in writing
You likely can't join if
- Other histology of BC than urothelial carcinoma – mixed tumours with urothelial features are allowed
- Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis
- Known contraindication to immunotherapy
- A history of autoimmune disease. Study Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- Study Subjects who meet any of the following criteria will be excluded from study entry: o History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan o Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- HIV positive
See the full eligibility criteria
- ≥18 years of age at the time of signing the Informed Consent Form
- For male Study Subjects: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
- Signed Informed Consent Form
- ECOG PS 0 or 1
- Is, according to the Investigator’s judgement, able to comply with the trial protocol
- Ability to understand the Participant Information Sheet orally and in writing
- Preoperative PET/CT of thorax, abdomen, and pelvis with no suspicion of organ metastases or lymph node metastasis* above the aortic bifurcation
- Study Subjects planned to undergo radical cystectomy due to histopathological or clinical documented muscle invasive urothelial carcinoma (including subtypes) stage cT2-4a in the urinary bladder following NAC** in cisplatin-fit Study Subjects
- Other histology of BC than urothelial carcinoma – mixed tumours with urothelial features are allowed
- Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis
- Known contraindication to immunotherapy
- A history of autoimmune disease. Study Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- Study Subjects who meet any of the following criteria will be excluded from study entry: o History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan o Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- HIV positive
- History of pneumonitis (History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Hepatitis B or hepatitis C infection
- Subjects who have received a live, attenuated vaccine within 28 days prior to enrolment
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.