ISRCTN22771691
Active, not recruiting
Phase 2
Phase II study of neoadjuvant immune checkpoint inhibitors in urothelial cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Queen Mary University of London
- Enrollment
- 58
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cohort\-specific inclusion criteria:
- •1\. Bladder cohort:
- •Histopathologically confirmed carcinoma of the urothelium (T1 high grade \-T4a) in the bladder with mixed or rare histological subtypes such as squamous cell or adenocarcinoma. Patients with mixed histologies are required to have a dominant non\-transitional cell pattern.
- •2\. UTUC cohort:
- •Histopathologically confirmed high grade or high risk upper urinary tract urothelial carcinoma (renal pelvis and ureter). This cohort includes all patients with upper tract malignancy who in the opinion of the investigators qualify for radical surgery (nephroureterectomy or distal ureter resection). Urothelial carcinoma of the upper urinary tract qualifies as high\-risk disease if any of the below factors are present:
- •2\.1\. Hydronephrosis
- •2\.2\. Tumour size \>2 cm on cross\-sectional imaging
- •2\.3\. High\-grade cytology
- •2\.4\. High\-grade biopsy
- •2\.5\. Multifocal disease
Exclusion Criteria
- •1\. Pregnant and lactating female patients
- •2\. Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- •3\. Previously intravenous chemotherapy for urothelial cancer
- •4\. Patients with prior allogeneic stem cell or solid organ transplantation
- •5\. Prior treatment with CD137 agonists, anti\-CTLA\-4, anti\-programmed death\-1 (PD\-1\), or anti\-PD\-L1 therapeutic antibody or pathway\-targeting agents
- •6\. Patients must not have had oral or IV steroids for 14 days prior to study entry. The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone) is allowed
- •7\. Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrolment (patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible)
- •8\. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study
- •9\. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL]\-2\) within 4 weeks or five half\-lives of the drug, whichever is shorter, prior to enrolment
- •10\. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment
Outcomes
Primary Outcomes
Not specified
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