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 range18 Years

SexALL

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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).
✓. 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

What they're measuring

Safety of MRx0518 and Avelumab combination treatment

Timeframe: Through study completion, an average of 1 year

Landmark PFS at 6 months from the date of first dose of study treatment for all patients

Timeframe: All patients after 6 months

Trial details

NCT IDNCT05107427

Sponsor4D pharma plc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04

View on ClinicalTrials.gov More Urothelial Carcinoma trials