Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
43
Countries
1
Sites
1
metastatic urothelial cancer
The primary endpoint is: non progressive rate at 6 months
Key facts
- Sponsor
- I.F.O. Istituti Fisioterapici Ospitalieri
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 8 Oct 2025
- Decision date (initial)
- 2025-02-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514979-17-04
- EudraCT number
- 2021-006501-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary endpoint is: non progressive rate at 6 months
Secondary objectives 1
- The secondary end points are: duration of response (DOR); disease control rate (DCR); time to progression (TTP); OS; safety. Exploratory Endpoints: To identify biomarkers in blood and tissue samples to evaluate the mechanism of immune-resistance Immunogenicity of pembrolizumab given in combination with metronomic cyclophoshamide
Conditions and MedDRA coding
metastatic urothelial cancer
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Progressive identification code according to methods defined by the studio
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514979-17-00 | PembrolizuMab beyond RECIST progression and oral metroNOmic cyclophosphamide in meTAstatic UROthelial cancer: a single-arm, multicentre, phase 2 trial: minotaURO study | I.F.O. Istituti Fisioterapici Ospitalieri |
| 2024-514979-17-03 | PembrolizuMab beyond RECIST progression and oral metroNOmic cyclophosphamide in meTAstatic UROthelial cancer: a single-arm, monocentre, phase 2 trial: minotaURO study | I.F.O. Istituti Fisioterapici Ospitalieri |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Age = 18 years; • Histological diagnosis of urothelial carcinoma, Advanced or metastatic disease; • PD-L1 expression: PD-L1 determined by immunohistochemistry (IHC; Dako 22C3 pharmDx assay; Agilent Technologies) at a local laboratory, with expressions scored using the combined positive score (CPS); • Eastern Cooperative Oncology Group performance status (ECOG PS) =2; • Adequate hematologic, renal, and hepatic function; RECIST 1.1 measurable disease; • Ongoing Pembrolizumab, as clinically indicated (progression after platinum-based chemotherapy); • Progression disease according to RECIST criteria; Criteria for receiving ICIs beyond RECIST v1.1 progression are: clinical benefit assessed by investigator, stable performance status, tolerance of treatment and no need to deliver immediate intervention to prevent serious complication of progression; iUPD(immune unconfirmed progressive disease according to iRECIST criteria); which require radiological confirmation; Oligometastatic disease: minimal metastatic state in which patients have a low burden of metastatic disease with only a small number of metastatic sites at initial presentation of their illness; Written informed consent
Exclusion criteria 1
- • Condition requiring treatment with glucocorticoids (equivalent to >10 mg of prednisone daily); • Hyperprogression condiction definited as two-fold or greater increase in the tumor growth rate in terms of volume during immunotherapy or a time to treatment failure of less than 2 months or a greater than 50% increase in tumor burden in two diameters according to irRC compared with pre-immunotherapy imaging that was obtained within 2 months of the initiation of the immuno-oncology agent, or a greater than two fold increase in progression pace with one diameter or a two fold or greater increase in the tumor growth rate in one diameter on immunotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Non progressive rate at 6 months
Secondary endpoints 1
- • The secondary end points are: duration of response (DOR); disease control rate (DCR); time to progression (TTP); OS; safety. Exploratory Endpoints: To identify biomarkers in blood and tissue samples to evaluate the mechanism of immune-resistance (Immunogenicity of pembrolizumab given in combination with metronomic cyclophoshamide
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD351418 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50.00 mg milligram(s)
- Max total dose
- 50.00 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- 6035903.00.01
- MA holder
- BAXTER ONCOLOGY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
I.F.O. Istituti Fisioterapici Ospitalieri
- Sponsor organisation
- I.F.O. Istituti Fisioterapici Ospitalieri
- Address
- Via Elio Chianesi N 53
- City
- Rome
- Postcode
- 00144
- Country
- Italy
Scientific contact point
- Organisation
- I.F.O. Istituti Fisioterapici Ospitalieri
- Contact name
- Massimo Zeuli
Public contact point
- Organisation
- I.F.O. Istituti Fisioterapici Ospitalieri
- Contact name
- Massimo Zeuli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 43 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024_514979_17_03 _V 1_3 _08012025 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements 15012025 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult v 1_2 08012025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC cyclophosphamide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ITA MS 2024_514979_17_03 _V 1_3 _08012025 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Italy | Acceptable with conditions 2025-01-30
|
2025-02-24 |