UnknownPhase 2

Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma

Taiwan29 participantsStarted 2020-12-25

Plain-language summary

The aim of this study is to explore efficacy and safety of neoadjuvant nivolumab for non-metastatic upper tract urothelial carcinoma (UTUC), and explore the potential predictive biomarkers of immunotherapy.

Who can participate

Age range20 Years – 85 Years

SexALL

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Inclusion criteria

✓. Have a histologically or clinically confirmed diagnosis of locally advanced (cT2-T4 and N0M0) urothelial carcinoma of the renal pelvis and/or ureter (UTUC). Pure urothelial carcinoma or urothelial carcinoma mixed with other histological variant are allowed, but urothelial carcinoma must be the predominant histology.
✓. Have at least a measurable lesion based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
✓. Voluntarily agree to participate by providing written informed consent/assent for the trial.
✓. Age (at the time of informed consent): 20 years and older
✓. Have received no prior systemic chemotherapy for advanced urothelial carcinoma, with the following exceptions:
✓. Platinum-based chemotherapy for previous a history of ipsilateral UTUC or bladder cancer in purpose of neoadjuvant or adjuvant treatment with recurrence \> 6 months from completion of therapy is permitted.
✓. Low-dose chemotherapy (e.g., low-dose cisplatin, cisplatin plus 5-FU, mitomycin plus 5-FU, or cisplatin plus paclitaxel) given concurrently with radiation to urothelial carcinoma of bladder is not considered systemic therapy.
✓. Have willing to provide tissue for exploratory biomarker analysis from a newly obtained core or excisional biopsy of a tumor lesion from the renal pelvis or ureter tumor.

Exclusion criteria

✕. Short-term (\<7 days) use of systemic corticosteroids is allowed when use is considered SOC.
✕. Subjects with vitiligo, type I diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy would be an exception to this rule.
✕. Subjects who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the trial.
✕. Exceptions include basal cell carcinoma of the skin; squamous cell carcinoma of the skin that has undergone potentially curative surgery; in situ cervical cancer; early stage of prostate cancer (stage 1) with low Gleason score ≤6; and prostate-specific antigen (PSA) undetectable.
✕. A history of urothelial carcinoma, including upper tract urothelial carcinoma or bladder cancer who received curative-intent surgery (nephroureterectomy, segmentectomy, TURBT, partial cystectomy, radical cystoprostectomy) \> 12 months before first-dose trial treatment will be the exception.
✕. Myocardial infarction within 180 days before first-dose of trial treatment
✕. New York Heart Association (NYHA) class III or IV congestive heart failure
✕. Myocarditis, no matter what etiology should be excluded

What they're measuring

pathologic complete response rate (pCR)

Timeframe: 1 month post neoadjuvant nivolumab and surgery

Trial details

NCT IDNCT05160285

SponsorYULISU

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

Contact for this trial

Yu-Li Su, MD

+886-975056834 yolisu@cgmh.org.tw

View on ClinicalTrials.gov More Upper Urinary Tract Urothelial Carcinoma trials