AzTrials
AzTrials

Squamous Cell CarcinomaPhase 2AURORANCT05038657

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

A Phase 2 study testing Atezolizumab in people with Squamous Cell Carcinoma and Urinary Tract Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma, Urinary Tract Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
30 May 2022to Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Patients who are pregnant or breastfeeding
  • Patients of child-bearing potential who are not able to use a highly effective method of contraception (as detailed in section 3.6)
  • A recent or current other cancer. Current non-melanoma skin cancer, cervical carcinoma in situ, or localized prostate cancer not requiring current treatment are permissible, as is a history of a separate other malignancy having completed all active treatment ≥2 years previously

Trial locations and contacts

1 site in 1 country.

Simon Crabb contact

02381203483

S.J.Crabb@southampton.ac.uk

Sarah-Jane Bibby contact

02381205773

aurora@soton.ac.uk

United Kingdom1 site, 1 recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, So16 6YD

    Simon Crabb, Prof

    Recruiting

Other trials in United Kingdom

About this study

Official title: Atezolizumab in Patients With Urinary Tract Squamous Cell Carcinoma: a Single Arm, Open Label, Multicentre, Phase II Clinical Trial

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

Read the detailed description

AURORA is a phase II open-label trial of Atezolizumab in patients with urinary tract squamous cell carcinoma (UTSCC). UTSCC is the most common of the rare urinary tract cancer histologies, comprising 2.1-6.7% of urinary tract cancers overall. There are few data available to guide treatment decisions for UTSCC. The AURORA trial will test the hypothesis that PD-L1 inhibition with atezolizumab immunotherapy is clinically effective, tolerable and safe, in patients with urinary tract squamous cell carcinoma (UTSCC). Translational endpoints will aim to determine characteristics for responsiveness to this treatment. AURORA was developed on behalf of the International Rare Cancers Initiative (IRCI) and the National Cancer Research Institute Bladder and Renal Group.

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Squamous Cell, Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Treatment

    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.

Study groups in NCT05038657
Study groupRoleWhat they receive
AtezolizumabExperimentalTreatment 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.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 36 months

Secondary outcomes (1)

  1. Progression free survival

    1. To determine the progression-free survival (PFS) of patients treated with atezolizumab in this clinical setting

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start30 May 2022
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038657
Sponsor's protocol ID
RHM
Acronym
AURORA
Status last verified
Sep 2021
First submitted
7 Sep 2021
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37726695

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Squamous Cell Carcinoma and Urinary Tract Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Simon Crabb (02381203483, S.J.Crabb@southampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05038657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in