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Urothelial CarcinomaPhase 2CHASITNCT05600127

Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer

A Phase 2 study testing Avelumab in people with Urothelial Carcinoma, run by Erasmus Medical Center at 4 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
4 sitesNetherlands
Study dates
1 Dec 2022to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years.
  • Have histologically confirmed urothelial carcinoma of the bladder, upper urinary tract or urethra; a maximum of 50% of aberrant histology is allowed.
  • Have clinical stage cT4NxM0 or cTxN1-N3M0 as assessed by bimanual examination under anaesthesia, CT scan, MRI scan or PET-CT scan.
  • Have at least stable disease after a minimum of 3 or a maximum of 4 cycles of induction chemotherapy with cisplatin / carboplatin + gemcitabine according to RECIST v1.1.
  • Are fit and willing to undergo radical surgery with removal of lymph node template including all affected lymph nodes and the primary tumor.
  • World Health Organisation performance status of 0-2.
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  • Provide written informed consent.
  • Negative pregnancy test in women with childbearing potential.
  • Adequate bone marrow function, including:
  • Absolute neutrophil count (ANC) ≥1,500/mm3 or 1.5 x 109/L;
  • Platelets ≥100 x 109/L;
  • Hemoglobin ≥5.6 mmol/L (may have been transfused).
  • Adequate renal function, defined as estimated creatinine clearance ≥30 mL/min as calculated by the CKD-EPI eGFR.
  • Adequate liver function, including:
  • Total serum bilirubin <1.5 x upper limit of normal (ULN);
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x ULN.

Who cannot join

  • Predominant (>50%) non-urothelial carcinoma histology in the diagnostic endoresection specimen of the bladder, urethra or upper urinary tract.
  • Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection.
  • Have an estimated creatinin clearance as assessed by the CKD-EPI eGFR of <30 ml/min.
  • Prior exposure to immune-mediated therapy with exclusion of Bacillus-Calmette Guérin intravesical instillations, including but not limited to other anti-CTLA-4, anti PD-1, anti PD-L1, or anti-PD-L2 antibodies.
  • Persisting toxicity related to prior chemotherapy (Grade >2 NCI CTCAE v5.0).
  • A diagnosis of any other malignancy within 2 years prior to inclusion, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease.
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  • ≤2 cycles of induction platinum-based chemotherapy received.
  • Progression of disease during or following induction platinum-based chemotherapy, as assessed by RECIST v1.1.
  • Distant metastatic disease.
  • Previous pelvic radiation therapy.
  • Breastfeeding women.
  • Bilateral upper urinary tract urothelial carcinoma.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
  • Active infection requiring systemic therapy.
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade 3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of asthma symptom control per the Global Initiative for Asthma 2015).
  • Known prior or suspected hypersensitivity to avelumab.
  • Current use of immunosuppressive medication, EXCEPT the following:
  • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
  • Systemic corticosteroids at (equivalent) doses of maximum 10 mg prednisone;
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  • Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy, or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (for example, inactivated influenza vaccines) or mRNA vaccines (for example, COVID-19 vaccines).
  • Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, and pneumonitis; psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

J L Boormans, MD PhD contact

0031 10 7032612

j.boormans@erasmusmc.nl

V C Rutten, MD contact

v.rutten@erasmusmc.nl

Netherlands4 sites, 4 recruiting

  • Jeroen Bosch ziekenhuis

    's-Hertogenbosch, North Brabant, 5223 GZ

    Smilde

    Smilde

    Recruiting

  • Amphia ziekenhuis

    Breda, North Brabant, 4818 CK

    Westgeest

    Leijte

    Recruiting

  • Radboud UMC

    Nijmegen, Gelderland, 6525 GD

    Mehra

    vd Heijden

    Recruiting

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD

    Boormans, chasit@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer: the CHASIT Study

Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.

Read the detailed description

Patients with locally advanced or clinically node positive urothelial carcinoma of the bladder, ureter or urethra (cT4NxM0 or cTxN1-N3M0) with at least stable disease after treatment with 3-4 cycles of platinum-based chemotherapy, will be treated with 3 cycles of avelumab (anti-PD-L1). If there are no signs of disease progression after avelumab treatment, radical surgery of the primary tumor and a pelvic lymph node dissection will follow.

Being tested
Avelumab
Keywords
Chemotherapy, Immunotherapy, Safety, Pathological response
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • AvelumabDrug

    Also called Bavencio

    3 cycles of avelumab (800mg, every 2 weeks)

Study groups in NCT05600127
Study groupRoleWhat they receive
AvelumabExperimental3 cycles of avelumab (Bavencio), 800mg intravenous instillation in 60 min, every 2 weeks.
Receives: Drug: Avelumab

What is being measured

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

  1. Pathological complete response rate

    the proportion of patients without residual UC in the surgical resection specimen, ypT0N0 (carcinoma situ is allowed), in the intention-to-treat analysis.

    Measured: About 1 month after radical surgery

Secondary outcomes (5)

  1. Survival

    Progression-free, cancer-specific and overall survival at 24 months, calculated from the time of 1st administration of avelumab

    Measured: 24 months after radical surgery

  2. Adverse events

    Adverse events of assessed by the CTCAE v5.0

    Measured: 90 days after administration of the last cycle of avelumab

  3. Surgical complications

    Assesed by Clavien-Dindo classification within 30 and 90 days from date of surgery

    Measured: 90 days after radical surgery

  4. Non-invasive urothelial cancer

    The rate of non-invasive urothelial cancer in the surgical resection specimen, stage ypT0N0/ypTisN0/ypTaN0/ypT1N0

    Measured: About 1 month after radical surgery

  5. Delay in surgery

    The proportion of patients in whom radical surgery is delayed >8 weeks after last administration of avelumab due to toxicity.

    Measured: About 1 month after radical surgery

Timeline

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

  1. First posted31 Oct 2022
  2. Study start1 Dec 2022
  3. Primary completionApr 2025 (estimated)
  4. Study completionDec 2026 (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
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05600127
Sponsor's protocol ID
NL80678.078.22
Acronym
CHASIT
Status last verified
Sep 2023
First submitted
26 Oct 2022
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rutten VC, Salhi Y, Robbrecht GJ, de Wit R, van Leenders GJLH, Zuiverloon TCM, Boormans JL. The CHASIT study: sequential chemo-immunotherapy in patients with locally advanced urothelial cancer - a non-randomized phase II clinical trial. BMC Cancer. 2023 Jun 13;23(1):539. doi: 10.1186/s12885-023-10963-7.

    PubMed 37312054

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab in people with Urothelial Carcinoma, run by Erasmus Medical Center at 4 sites in Netherlands.

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 16 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact J L Boormans, MD PhD (0031 10 7032612, j.boormans@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: About 1 month after radical surgery). 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 NCT05600127, 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 8 Sep 2023.

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