Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma (NCT05107427) | Clinical Trial Compass
WithdrawnPhase 2
Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma
Stopped: Sponsor unable to proceed
United States0Started 2022-03-01
Plain-language summary
This is an open-label, switch maintenance study of MRx0518 and Avelumab in patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress after 4 to 6 cycles of first-line platinum-containing chemotherapy and who have residual measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Up to 30 patients will be enrolled.
Patients enrolled in this study will be treated with IV Avelumab every 2 weeks and MRx0518 daily during the treatment period. Patients will receive the study treatment until disease progression (PD), patient withdrawal, or unacceptable toxicity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide informed consent.
. Age ≥18 years at the time of consent.
. Histologically confirmed unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium.
. Documented Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis (TNM) system, 7th edition) (AJCC 2012) at the start of first-line chemotherapy.
. Prior first-line chemotherapy consisting of at least 4 but not more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin and/or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) with last dose received no less than 4, and no more than 10 weeks prior to date of first study treatment dose.
. No evidence of PD during or following first-line chemotherapy (ie, ongoing PR or SD per RECIST v1.1).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of MRx0518 and Avelumab combination treatment
Timeframe: Through study completion, an average of 1 year
2
Landmark PFS at 6 months from the date of first dose of study treatment for all patients
. At least 1 measurable lesion per RECIST v1.1 after completion of first-line chemotherapy.
. Willing to undergo mandatory de novo tumor biopsies at baseline and Cycle 3 in the absence of existing biopsy material without intervening therapy.
Exclusion criteria
. Persisting toxicity related to prior therapy NCI-CTCAE Grade \>1) at the time of enrollment; however, alopecia, sensory neuropathy Grade ≤2 is acceptable; or other grade ≤2 AEs not constituting a safety risk based on the investigator's judgment are acceptable.
. Prior immunotherapy with IL-2, interferon (IFN)-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
. Prior adjuvant or neoadjuvant systemic therapy within 12 months of enrollment.
. Known symptomatic central nervous system (CNS) metastases requiring steroids. Patients with previously diagnosed CNS metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable.
. CR to the preceding platinum-based chemotherapy for locally advanced or metastatic disease received systemic antibiotics within 2 weeks prior to first dose.
. Received systemic antibiotics within 2 weeks prior to first dose.
. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this study.
. Female patients who are pregnant or breastfeeding.