A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-… (NCT04660344) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
United States, Argentina, Belgium761 participantsStarted 2021-05-03
Plain-language summary
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion Criteria for the Surveillance Phase:
* Histologically confirmed MIUC (also termed transitional cell carcinoma \[TCC\]) of the bladder
* Tumor, nodes, and metastases (TNM) classification (based on American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For participants treated with prior neoadjuvant chemotherapy (NAC): tumor stage of ypT2-4a or ypN+ and M0. For participants who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
* Surgical resection of MIUC of the bladder
* Participants who have not received prior platinum-based NAC must be ineligible for cisplatin-based adjuvant chemotherapy, have refused it, or will not receive it based on physician's decision
* ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood
* Tumor programmed death ligand (PD-L1) expression per immunohistochemistry (IHC) that is evaluable by central testing of a representative tumor tissue specimen
* Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to enrollment
* Full recovery from cystectomy and enrollment within 24 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery
Additional Inclusion Criteria for the Treatment Phas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is only enrolling people who test positive for ctDNA — circulating tumor DNA — after bladder removal surgery. Can you test my ctDNA levels, and does my result affect whether this trial or a different treatment path might make more sense for me?
2Since this is a Phase 3 trial comparing atezolizumab directly against a placebo, what do we know so far about the safety profile of atezolizumab in bladder cancer, and what side effects should I realistically prepare for if I were assigned to the treatment arm?
3The trial is no longer actively recruiting — so if I can't enroll, are there other immunotherapy options or adjuvant treatments you'd recommend for high-risk muscle-invasive bladder cancer after cystectomy?
4The main thing this trial is measuring is disease-free survival — meaning how long before the cancer comes back or spreads. Based on my specific pathology and ctDNA status, what does my risk of recurrence look like, and how does that shape which treatment approach you'd recommend?
5If I were on this trial and assigned to the placebo group, would I still have access to other standard-of-care treatments, or would being on the placebo arm mean forgoing options that might otherwise be available to me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.