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Bladder CancerPhase 2TOMBOLANCT04138628

Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy

A Phase 2 study testing Atezolizumab in people with Bladder Cancer and Bladder Cancer, Metastatic, run by Jørgen Bjerggaard Jensen at 5 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer. However, response rates are low and no biomarkers have yet shown strong predictive value for patient selection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Bladder Cancer, Metastatic
What is being tested?
Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
5 sitesDenmark
Study dates
24 Mar 2020to 1 Nov 2030
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

  • ≥18 years of age at the time of signing the Informed Consent Form
  • For male study subjects: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
  • Signed Informed Consent Form
  • ECOG PS 0, 1 or 2
  • Is, according to the Investigator's judgement, able to comply with the trial protocol
  • Ability to understand the Participant Information Sheet orally and in writing
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  • Preoperative PET/CT of thorax, abdomen, and pelvis with no suspicion of organ metastases or lymph node metastasis* above the aortic bifuraction
  • Study Subjects undergoing radical cystectomy due to histologically documented muscle invasive urothelial carcinoma (including subtypes) stage cT2-4a in the urinary bladder following NAC** in cisplatin-fit Study Subjects.
  • Study Subjects who have undergone down-staging chemotherapy because of lymph node metastasis with no organ metastases can be included if complete response regarding lymph nodes are identified on preoperative imaging.
  • NAC includes Study Subjects who have stopped after one course of chemotherapy because of side effects or local non-metastatic progression

Who cannot join

  • Subjects undergoing non-radical cystectomy for palliative reasons
  • Non-radical surgery estimated intraoperative
  • Other histology of BC than urothelial carcinoma - mixed tumours with urothelial features are allowed
  • Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis
  • Known contraindication to immunotherapy
  • A history of autoimmune disease. Study Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
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  • Study Subjects who meet any of the following criteria will be excluded from study entry:
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
  • HIV positive
  • History of pneumonitis (History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Hepatitis B or hepatitis C infection
  • Subjects who have received a live, attenuated vaccine within 28 days prior to enrolment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Aalborg Universitetshospital

    Aalborg, 9100

  • Aarhus University Hospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

About this study

Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer. However, response rates are low and no biomarkers have yet shown strong predictive value for patient selection. Moreover, the term 'metastatic' is based on metastases visible on conventional CT scans and, thus, require a certain size of tumour load. Clinical trials are currently being conducted that investigate the use of adjuvant immunotherapy for this group of patients (treatment to all), which will result in massive over-treatment and huge costs to the healthcare system.

This project has the primary objective to identify new indications for initiating immunotherapy in patients with metastatic bladder cancer. Sensitive molecular techniques for detection of tumor DNA in the blood will be used to identify patients with early signs of metastatic disease. In addition, comprehensive biomarker analysis will be performed to identify predictors of treatment response.

Read the detailed description

The study aim at investigate the response rate and oncological outcome of systemic immunotherapy (PDL-1 inhibitor; atezolizumab) administered early at the time of biochemical relapse (circulating tumor DNA (ctDNA) positive) in patients who have undergone radical cystectomy because of muscle invasive bladder cancer.

Biomarkers that predict response to systemic immunotherapy will be identified by comprehensive multi-omics analysis of primary tumors and metastatic lesions. Furthermore, we will determine if ctDNA levels during therapy can be used as a biomarker for early indication of therapy response.

The hypotheses is that 1) early initiation of immunotherapy in high-risk (ctDNA positive) patients will result in better response rates and improved survival compared to later treatment following conventional imaging diagnosis of metastasis, and 2) biomarkers for predicting response can be identified and used for tailoring treatment regimens in the future to patients at high risk and at high likelihood of response.

Being tested
Atezolizumab
Keywords
Muscle Invasive Bladder Cancer (MIBC), biomarkers, ctDNA, immunotherapy, circulating tumor DNA, liquid biopsies
Medical subject headings
Urinary Bladder Neoplasms, Neoplasm Metastasis

What participants receive

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

  • AtezolizumabDrug

    The study drug will be given according to current recommendations as systemic treatment every third week for 12 months or until progression. Treatment will be initiated within 28 days of detection of ctDNA.

Study groups in NCT04138628
Study groupRoleWhat they receive
ctDNA screening armExperimentalFlat dose 1200 mg Atezolizumab every three weeks for up to 13 months
Receives: Drug: Atezolizumab

What is being measured

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

  1. Complete response (CR) after treatment with investigational agent initiated by ctDNA positive status after radical cystectomy (with or without concomitant visible metastases on CT).

    CR in the current study is defined as ctDNA negative status combined with regular imaging (CT) after treatment. Thus, any metastasis visible on CT at the time of treatment initiation should undergo complete response. In Study Subjects without visible metastasis on CT at the time of treatment, initiation should result in unchanged status on CT.

    Data will be compared to available historical data on response to PD-1 / PD-L1 targeted agents.

    Measured: Time from treatment initiation with investigational agent until 12 months after initiation

Secondary outcomes (7)

  1. Duration of freedom from clinical relapse in Study Subjects showing decrease or stabilization of ctDNA level after treatment with investigational agent

    Time from initiation of therapy until response

    Measured: 12 months

  2. Overall survival after cystectomy in Study Subjects having biochemical relapse

    Percentage

    Measured: 5 years

  3. Cancer specific survival after cystectomy in Study Subjects having biochemical relapse

    Percentage

    Measured: 5 years

  4. Recurrence free survival after cystectomy in Study Subjects having biochemical relapse

    Percentage

    Measured: 5 years

  5. Cancer specific survival after cystectomy in Study Subjects having biochemical relapse stratified for potential predictive biomarkers for response to treatment

    Percentage

    Measured: 5 years

  6. Response rate to investigated agent stratified for PD-L1 expression and other predictive biomarkers like TMB, immune cell infiltration, tumor subtypes etc.

    Percentage

    Measured: 12 months

  7. Time to recurrence seen on imaging (symptomatic or asymptomatic)

    Percentage

    Measured: 5 years

Timeline

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

  1. First posted24 Oct 2019
  2. Study start24 Mar 2020
  3. Primary completion1 Aug 2024
  4. Study completion1 Nov 2030 (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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Single country Investigator Initiated, Open-label, Single-arm, Non-randomized, Phase II study
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04138628
Sponsor's protocol ID
DaBlaCa-14
Other IDs
2019-001679-36, 2019
Acronym
TOMBOLA
Status last verified
Feb 2026
First submitted
23 Oct 2019
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Bladder Cancer and Bladder Cancer, Metastatic, run by Jørgen Bjerggaard Jensen at 5 sites in Denmark.

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 10 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) after treatment with investigational agent initiated by ctDNA positive status after radical cystectomy (with or without concomitant visible metastases on CT). (time frame: Time from treatment initiation with investigational agent until 12 months after initiation). 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 NCT04138628.

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 7 Apr 2026.

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