EUCTR2019-004628-39-ES
Active, not recruiting
Phase 1
A phase II study of neoadjuvant immune checkpoint inhibitors in urothelial cancer - ABACUS-2
DrugsTecentriq
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Queen Mary University of London
- Enrollment
- 58
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willing and able to provide written informed consent
- •2\. Ability to comply with the protocol
- •3\. Age \= 18 years
- •4\. Residual disease after TURBT or ureteroscopy (surgical opinion, cystoscopy/ ureteroscopy or radiological evidence).
- •5\. Fit and planned for cystectomy or radical surgery of the upper tract (according to local guidelines).
- •6\. N0 or M0 disease CT or MRI (within 4 weeks of registration)
- •7\. Representative formalin\-fixed paraffin embedded (FFPE) tumour samples with an associated pathology report that are determined to be available and sufficient for central testing.
- •8\. Patients who refuse neoadjuvant cisplatin\-based chemotherapy or in whom neoadjuvant cisplatin\-based therapy is not appropriate.
- •9\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •10\. Negative pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.
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 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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