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New treatment option for Upper Tract Urothelial Carcinoma
Official title Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
ClinicalTrials.gov ID: NCT07225374
What this study is testing
What is Avelumab 10 mg/kg?
Avelumab 10 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for upper tract urothelial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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. people must have recovered to \<Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
- 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 people with Gilbert's syndrome diagnosed as per institutional guidelines. B. AST (SGOT) and ALT (SGPT) 3 x ULN or...
- 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...
- Written and voluntary informed consent understood, signed and dated.
- Negative serum or urine pregnancy test at screening for women of childbearing potential.
- 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...
- 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
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Gangnam, South Korea
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, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Gangnam, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.