A phase II study of neoadjuvant immune checkpoint inhibitors in urothelial cancer - ABACUS-2

Queen Mary University of London0 sites58 target enrollmentOctober 7, 2020

ConditionsTumours of the urothelial tract requiring surgery (T1 high grade-T4a of the bladder, rare histological subtypes) and upper urinary tract (high grade or high risk)MedDRA version: 20.0Level: LLTClassification code 10046384Term: Ureteral cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10026426Term: Malignant neoplasm of renal pelvisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTecentriq

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tumours of the urothelial tract requiring surgery (T1 high grade-T4a of the bladder, rare histological subtypes) and upper urinary tract (high grade or high risk)
Sponsor: Queen Mary University of London
Enrollment: 58
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 7, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Queen Mary University of London

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 URS (surgical opinion, endoscopy or radiological presence).
•5\.Fit and planned for radical surgery with curative intent in the opinion of the investigator (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\-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.