Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy
New immunotherapy approach for bladder cancer after surgery
Plain English Summary
Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy is a Phase 2 clinical trial sponsored by Jørgen Bjerggaard Jensen studying Bladder Cancer, Bladder Cancer, Metastatic. This trial tests if a new immunotherapy drug can help patients with bladder cancer that has returned after surgery. It is for patients who have had their bladder removed and show signs of cancer returning, even if not visible on scans. Participants will receive an immunotherapy drug, Atezolizumab, for up to 12 months, starting soon after cancer DNA is detected in their blood. Standard treatments for returning bladder cancer include chemotherapy or other targeted therapies, depending on the situation. The trial aims to enroll 154 participants.
Official 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. 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a specific type of bladder cancer (urothelial carcinoma) that has returned after bladder removal surgery. Patients must have no signs of cancer spread to distant organs (organ metastases) before starting the trial. Individuals with certain autoimmune conditions or recent use of immunosuppressive medications may not be eligible. Patients must be able to provide informed consent and comply with trial procedures. This trial is studying Bladder Cancer, Bladder Cancer, Metastatic, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if the immunotherapy drug can eliminate or control the returning cancer, measured by the complete disappearance of cancer. The specific primary outcome measures are: 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 from treatment initiation with investigational agent until 12 months after initiation). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses the need for more effective treatments for bladder cancer that returns after surgery, especially when detected early through blood tests, potentially preventing overtreatment and Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Bladder Cancer, Bladder Cancer, Metastatic, where improved treatment options are needed.
Investor Insight
This trial explores early detection and treatment of recurrent bladder cancer using immunotherapy, a growing area in cancer treatment, with potential to improve patient survival and reduce healthcare Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific type of bladder cancer you have and what the signs of recurrence mean. Understand how the immunotherapy drug is given and what side effects might occur. Be prepared for regular blood tests to monitor for cancer DNA and potential follow-up scans. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 154 participants
Interventions
- DRUG: Atezolizumab — 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.
Primary Outcomes
- 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 from treatment initiation with investigational agent until 12 months after initiation)
Secondary Outcomes
- Duration of freedom from clinical relapse in Study Subjects showing decrease or stabilization of ctDNA level after treatment with investigational agent (12 months)
- Overall survival after cystectomy in Study Subjects having biochemical relapse (5 years)
- Cancer specific survival after cystectomy in Study Subjects having biochemical relapse (5 years)
- Recurrence free survival after cystectomy in Study Subjects having biochemical relapse (5 years)
- Cancer specific survival after cystectomy in Study Subjects having biochemical relapse stratified for potential predictive biomarkers for response to treatment (5 years)
Full Eligibility Criteria
Inclusion Criteria:
* ≥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
* 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
Exclusion Criteria:
* 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.
* 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 enrolmentTrial Locations
- Aalborg Universitetshospital, Aalborg, Denmark
- Aarhus University Hospital, Aarhus, Denmark
- Rigshospitalet, Copenhagen, Denmark
- Herlev Hospital, Herlev, Denmark
- Odense Universitetshospital, Odense, Denmark
Frequently Asked Questions
What is clinical trial NCT04138628?
NCT04138628 is a Phase 2 INTERVENTIONAL study titled "Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy." It is currently active, not recruiting and is sponsored by Jørgen Bjerggaard Jensen. The trial targets enrollment of 154 participants.
What conditions does NCT04138628 study?
This trial investigates treatments for Bladder Cancer, Bladder Cancer, Metastatic. The primary condition under study is Bladder Cancer.
What treatments are being tested in NCT04138628?
The interventions being studied include: Atezolizumab (DRUG). 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.
What does Phase 2 mean for NCT04138628?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT04138628?
This trial is currently "Active, Not Recruiting." It started on 2020-03-24. The estimated completion date is 2030-11-01.
Who is sponsoring NCT04138628?
NCT04138628 is sponsored by Jørgen Bjerggaard Jensen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04138628?
The trial aims to enroll 154 participants. The trial status is active, not recruiting.
How is NCT04138628 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04138628?
The primary outcome measures are: 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 from treatment initiation with investigational agent until 12 months after initiation). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04138628 being conducted?
This trial is being conducted at 5 sites, including Aalborg; Aarhus; Copenhagen; Herlev and 1 more sites (Denmark).
Where can I find official information about NCT04138628?
The official record for NCT04138628 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04138628. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04138628 testing in simple terms?
This trial tests if a new immunotherapy drug can help patients with bladder cancer that has returned after surgery. It is for patients who have had their bladder removed and show signs of cancer returning, even if not visible on scans.
Why is this trial significant?
This trial addresses the need for more effective treatments for bladder cancer that returns after surgery, especially when detected early through blood tests, potentially preventing overtreatment and
What are the potential risks of participating in NCT04138628?
Common side effects of immunotherapy can include fatigue, rash, and flu-like symptoms. More serious side effects can affect organs like the lungs, liver, or thyroid, requiring prompt medical attention. There is a risk that the treatment may not be effective for everyone. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04138628?
Ask your doctor about the specific type of bladder cancer you have and what the signs of recurrence mean. Understand how the immunotherapy drug is given and what side effects might occur. Be prepared for regular blood tests to monitor for cancer DNA and potential follow-up scans. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04138628 signal from an investment perspective?
This trial explores early detection and treatment of recurrent bladder cancer using immunotherapy, a growing area in cancer treatment, with potential to improve patient survival and reduce healthcare This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive an immunotherapy drug, Atezolizumab, for up to 12 months, starting soon after cancer DNA is detected in their blood. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.