Upper Tract Urothelial CarcinomaPhase 2NCT07225374
Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
A Phase 2 study testing Avelumab 10 mg/kg, Screening and Follow-up plan in people with Upper Tract Urothelial Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- Avelumab 10 mg/kg, Screening and Follow-up plan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2025to 2 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be aged 19 years or more
- Must have histologically or cytologically proven UTUC arising from renal pelvis and/or ureter.
- Must have histological evidence of high-risk muscle-invasive disease (i.e., pT2~ T4) and/or N+ disease.
- Must have an ECOG performance status of 0 to 1
- Received at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy, and proved to have no evidence of disease recurrence with imaging studies, urine cytology and cystoscopy
- At least 3 weeks since the last surgical procedures or chemotherapy prior to enrolment. Subjects must have recovered to <Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
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- Adequate marrow function without growth factor support or transfusion dependency A. Neutrophil 1,500 cells/μL or more B. Platelet count 100,000/μL or more C. Hemoglobin 9.0 g/dL or more
- Adequate renal function with serum creatinine 1.5 x ULN or a calculated creatinine clearance ≥ 50 mL/min using the CockcroftGault or MDRD formulas
- Adequate hepatic function A. Bilirubin 1.5 times upper limit of normal (x ULN) or less; does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines. B. AST (SGOT) and ALT (SGPT) 3 x ULN or less; if liver metastases are present, then 5 x ULN is allowed.
- Women of childbearing potential must use effective contraception continuously for at least 30 days after the final dose of avelumab. At least one method classified as "highly effective" (failure rate < 1%) must be employed (see Table 1).
- Written and voluntary informed consent understood, signed and dated.
- Negative serum or urine pregnancy test at screening for women of childbearing potential.
Who cannot join
- Ongoing treatment with an anticancer agent not contemplated in this protocol
- Radiologic finding consistent with metastatic disease
- Severe medical or psychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation
- Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
- Major surgery, other than diagnostic surgery or transurethral resection, within 4 weeks prior to Cycle 1 Day 1, without complete recovery
- Double primary cancer of other site(s) or a history of other malignancies, except for cured ones at the discretion of investigator
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- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Subjects who have exhibited allergic reactions to study treatment.
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- Subject with legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). 12) Active autoimmune disease requiring systemic immunosuppressive treatment. Patients with controlled autoimmune disease not requiring systemic immunosuppressive treatment including diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
- Persisting toxicity related to prior therapy (NCI CTCAE Grade >
- 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Lactating Women Must discontinue breastfeeding during study treatment and for at least 30 days after administration of the final dose of study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam, 06351
Se Hoon Professor Park, M.D, +82-2-2008-4390
Eun Kyung Park, Bachelor, RN, +82-2-2008-4390, ekek.park@samsung.com
About this study
Official title: A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
Read the detailed description
Upper tract urothelial carcinoma (UTUC), including those that arise in the renal pelvis or in ureter, are relatively uncommon but highlyinvasive. Although radical surgery followed by adjuvant chemotherapy is considered a standard in the management of UTUC, a significant percentage of patients experience recurrence, leading to a poor prognosis. Nivolumab has been investigated for adjuvant treatment in the other trial, but unfortunately, a better DFS was not observed in patients with UTUC. Given the promising efficacy of the maintenance avelumab following first-line chemotherapy, the maintenance strategy looks promising in the adjuvant setting of curatively-resected UTUC.
- Conditions
- Upper Tract Urothelial Carcinoma
- Being tested
- Avelumab 10 mg/kg, Screening, Best Supportive Care (BSC), Follow-up plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelumab 10 mg/kgDrug
Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive avelumab 10 mg/kg as a
1-h infusion every 2 weeks. Avelumab will repeat every 2 weeks on an outpatient basis and continued until disease recurrence, unacceptable toxicity, consent withdrawal, or for a maximum of 1 year.
ScreeningProcedure or surgery
Screening numbers are endowed to all patients who sign the informed consent forms.
These screening numbers are used as 'Subject Identification Code" along with patient initials. Patients withdrawn from the study retain their screening number. New patients must always be allotted with a new screening number.
Best Supportive Care (BSC)Procedure or surgery
All study subjects will be also eligible to receive best supportive care (BSC) defined as any standard supportive measures that are not considered a primary treatment of the disease under study, including the use of growth factors (i.e. G-CSF) for myelosuppression, analgesics and transfusion of blood products. BSC will be provided at the discretion of the investigators.
Follow-up planOther
All patients are to have a clinic visit every 2 weeks (+3 days) during during study treatment. Tumor assessments will be performed at screening and approximately every 12 weeks, or sooner if deemed necessary by the investigator. A tumor assessment will be performed upon treatment discontinuation (End of Treatment visit) if the reason for discontinuation is other than disease progression and no tumor assessment was performed in the prior 12 weeks, or a tumor assessment is required for the confirmation of DFS.
| Study group | Role | What they receive |
|---|---|---|
| Single arm (Avelumab) | Experimental | It is a single arm study and in this arm patients who meet all of the inclusion criteria and none of the exclusion criteria will receive avelumab 10 mg/kg as a
1-h infusion every 2 weeks. Avelumab will repeat every 2 weeks on an outpatient basis and continued until disease recurrence, unacceptable toxicity, consent withdrawal, or for a maximum of 1 year. Receives: Drug: Avelumab 10 mg/kg; Procedure: Screening; Procedure: Best Supportive Care (BSC); Other: Follow-up plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Disease-free survival (DFS)
Measured: In brief, CT scans (or MRIs) will be performed every 12 weeks during study treatment, through study completion, until progression of disease or 1 year starting from enrollment of study.
Secondary outcomes (1)
Progression free survival
Progression will be evaluated in this study using the RECIST 1.1 criteria.
Measured: All subjects will be evaluated PFS as the time from the date of first study treatment to the date of disease progression or death, whichever comes first through the study, or 1 year starting from enrollment of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start16 Sep 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion2 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park, Se-Hoon, Samsung Medical Center
- Investigators
- SE HOON PARK, MD,PhD, Principal investigator, SamsungMedicalCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225374
- Sponsor's protocol ID
- 2025-03-132
- Other IDs
- KCT0010668
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07225374
- Acronym / sponsor ID
- 2025-03-132
- Conditions
- Upper Tract Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 2 Jul 2029 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
Detailed description
Upper tract urothelial carcinoma (UTUC), including those that arise in the renal pelvis or in ureter, are relatively uncommon but highlyinvasive. Although radical surgery followed by adjuvant chemotherapy is considered a standard in the management of UTUC, a significant percentage of patients experience recurrence, leading to a poor prognosis. Nivolumab has been investigated for adjuvant treatment in the other trial, but unfortunately, a better DFS was not observed in patients with UTUC. Given the promising efficacy of the maintenance avelumab following first-line chemotherapy, the maintenance strategy looks promising in the adjuvant setting of curatively-resected UTUC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm (Avelumab) | Experimental | Drug: Avelumab 10 mg/kg, Procedure: Screening, Procedure: Best Supportive Care (BSC), Other: Follow-up planIt is a single arm study and in this arm patients who meet all of the inclusion criteria and none of the exclusion criteria will receive avelumab 10 mg/kg as a 1-h infusion every 2 weeks. Avelumab will repeat every 2 weeks on an outpatient basis and continued until disease recurrence, unacceptable toxicity, consent withdrawal, or for a maximum of 1 year. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must be aged 19 years or more
- Must have histologically or cytologically proven UTUC arising from renal pelvis and/or ureter.
- Must have histological evidence of high-risk muscle-invasive disease (i.e., pT2~ T4) and/or N+ disease.
- Must have an ECOG performance status of 0 to 1
- Received at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy, and proved to have no evidence of disease recurrence with imaging studies, urine cytology and cystoscopy
Key exclusion criteria (16 listed)
- Ongoing treatment with an anticancer agent not contemplated in this protocol
- Radiologic finding consistent with metastatic disease
- Severe medical or psychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation
- Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
- Major surgery, other than diagnostic surgery or transurethral resection, within 4 weeks prior to Cycle 1 Day 1, without complete recovery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avelumab 10 mg/kgPatients who meet all of the inclusion criteria and none of the exclusion criteria will receive avelumab 10 mg/kg as a 1-h infusion every 2 weeks. Avelumab will repeat every 2 weeks on an outpatient basis and continued until disease recurrence, unacceptable toxicity, consent withdrawal, or for a maximum of 1 year. | Drug | Single arm (Avelumab) |
| ScreeningScreening numbers are endowed to all patients who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with patient initials. Patients withdrawn from the study retain their screening number. New patients must always be allotted with a new screening number. | Procedure or surgery | Single arm (Avelumab) |
| Best Supportive Care (BSC)All study subjects will be also eligible to receive best supportive care (BSC) defined as any standard supportive measures that are not considered a primary treatment of the disease under study, including the use of growth factors (i.e. G-CSF) for myelosuppression, analgesics and transfusion of blood products. BSC will be provided at the discretion of the investigators. | Procedure or surgery | Single arm (Avelumab) |
| Follow-up planAll patients are to have a clinic visit every 2 weeks (+3 days) during during study treatment. Tumor assessments will be performed at screening and approximately every 12 weeks, or sooner if deemed necessary by the investigator. A tumor assessment will be performed upon treatment discontinuation (End of Treatment visit) if the reason for discontinuation is other than disease progression and no tumor assessment was performed in the prior 12 weeks, or a tumor assessment is required for the confirmation of DFS. | Other | Single arm (Avelumab) |
Primary outcome
Disease-free survival (DFS)
Time frame: In brief, CT scans (or MRIs) will be performed every 12 weeks during study treatment, through study completion, until progression of disease or 1 year starting from enrollment of study.
Disease-free survival (DFS)
1 secondary outcome
Progression free survival
Time frame: All subjects will be evaluated PFS as the time from the date of first study treatment to the date of disease progression or death, whichever comes first through the study, or 1 year starting from enrollment of study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SE HOON PARK, MD,PhD principal investigator
SamsungMedicalCenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab 10 mg/kg, Screening and Follow-up plan in people with Upper Tract Urothelial Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SE HOON Park, MD,PhD (82-2-3410-3767, hematoma@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: In brief, CT scans (or MRIs) will be performed every 12 weeks during study treatment, through study completion, until progression of disease or 1 year starting from enrollment of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.