Atezolizumab Immunotherapy, in Immunotherapy Naive Patients With Urinary Tract Squamous Cell Carcinoma (UTSCC).

NCT05038657 | Unknown Phase 2 DMC

• 1 other identifier: RHM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Atezolizumab in patients with urinary tract squamous cell carcinoma: a single-arm, open-label, multicentre, phase II clinical trial

Conditions

Squamous Cell Carcinoma; Urinary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Response to

  To determine the clinical activity of atezolizumab in patients with incurable histologically confirmed, immunotherapy naïve UTSCC To determine the clinical activity of atezolizumab in patients with incurable histologically confirmed, immunotherapy naïve UTSCC

  36 months

Secondary Outcomes (1)

• Progression free survival

  36 months

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Treatment will consist of atezolizumab, by IV infusion, at a fixed dose of 1680 mg, every 28 days (day 1 of each cycle, +/- 3 days), for up to one year. Each participant will receive up to 13 doses in total.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Treatment will consist of atezolizumab, by IV infusion, at a fixed dose of 1680 mg, every 28 days (day 1 of each cycle, +/- 3 days), for up to one year. Each participant will receive up to 13 doses in total.

Also known as: Treatment

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically confirmed cancer of the urinary tract with squamous cell carcinoma histology and without any TCC component. Mixed non-TCC histology is allowed if squamous cell carcinoma is the predominant histology 2. Newly diagnosed or progressive measurable disease as defined by RECIST version 1.1. To be considered measurable (and to be designated as a target lesion), a lesion must not have been treated with prior radiotherapy or focal ablation techniques 3. Suitable, in the judgment of the local investigator, for treatment with atezolizumab, with palliative intent 4. Adequate haematologic and end-organ function within 28 days prior to the first study treatment including:
• Absolute neutrophil count ≥ 1.5 x109/L
• Platelet count ≥ 100 x109/L
• Haemoglobin ≥ 90 g/L
• Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase ≤ 2.5 times the institutional upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 times ULN (or ≤ 3 ULN in patients with Gilbert's syndrome)
• Calculated creatinine clearance ≥ 20 mL/min (Cockcroft-Gault formula) 5. Up to one prior line of systemic chemotherapy for UTSCC 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 7. Life expectancy ≥ 12 weeks 8. Representative formalin-fixed paraffin-embedded (FFPE) tumour sample with an associated linked-anonymised pathology report that is available for central use in translational studies 9. Able to comply with all trial procedures and processes 10. Aged 18 years or over 11. Provision of written informed consent

You may not qualify if:

• Any component of TCC histology
• Planned for treatment with curative intent
• Prior systemic immunotherapy (prior intra-vesical treatments are allowed)
• Major surgery within 30 days prior to enrolment
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• Use of oral or IV steroids for 14 days prior to enrolment. Use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone) is allowed
• Administration of a live or attenuated vaccine within 4 weeks prior to enrolment (COVID-19 vaccination is allowed)
• Treatment with any other investigational agent within 4 weeks prior to enrolment
• Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable arrhythmias, unstable angina or congestive cardiac failure (New York Heart Association ≥ grade 2) within 6 months prior to enrolment
• Patients with known HIV infection or with active tuberculosis
• Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
• Autoimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. A history of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Prior allogeneic stem cell or solid organ transplant

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Cancer Research UK: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, So16 6YD, United Kingdom

RECRUITING

Related Publications (1)

• Crabb S, Wickens R, Jane-Bibby S, Dunkley D, Lawrence M, Knight A, Jones R, Birtle A, Huddart R, Linch M, Martin J, Coleman A, Boukas K, Markham H, Griffiths G. Evaluating atezolizumab in patients with urinary tract squamous cell carcinoma (AURORA): study protocol for a single arm, open-label, multicentre, phase II clinical trial. BMC Cancer. 2023 Sep 19;23(1):885. doi: 10.1186/s12885-023-11397-x.

  PMID: 37726695 DERIVED

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Urologic Neoplasms

Interventions

atezolizumab; Therapeutics

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Officials

• Simon Crabb

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Crabb

CONTACT

02381203483; S.J.Crabb@southampton.ac.uk

Sarah-Jane Bibby

CONTACT

02381205773; aurora@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a Simon's 2-Stage optimal design with best ORR (% with a confirmed partial or complete response by RECIST v1.1) at a minimum of 12 weeks from commencing treatment as the primary endpoint.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 9, 2021
• Study Start: May 30, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 3, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)