Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized trial investigates if active surveillance is feasible vs continued systemic PD-1/PD-L1 inhibitor therapy in patients with extensive, transurethral unresectable, very-high-risk non-muscle-invasive bladder cancer who have achieved tumor-free status after initial treatment. Participants receive PD-1/PD-L1–based therapy followed by rigorous disease evaluation using cystoscopy with biopsy or TURBT, urine cytology, urinary tumor DNA, and imaging, to determine eligibility and response. After achieving tumor-free status, they are randomized to stop treatment with active monitoring or continue immunotherapy to maintain disease control. The study addresses balance between potential long-term toxicity, burden, and cost of ongoing therapy and the possibility of durable remission without continued treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.
* Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and/or extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.
* Has undergone cystoscopy and TURBT evaluation before study enrollment.
* Has received systemic PD-1/PD-L1 inhibitor-based bladder-sparing therapy before randomization.
* Has achieved tumor-free status before randomization, defined as:

  1. No visible bladder tumor on cystoscopy;
  2. Negative bladder biopsy and/or TURBT pathology;
  3. Negative urine cytology;
  4. Negative urinary tumor DNA (utDNA);
  5. No radiographic evidence of progression or metastasis.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Has adequate organ function.
* Has provided written informed consent.

Cohort A Only

* Achieved tumor-free status at the initial response evaluation after induction systemic therapy.
* Maintained tumor-free status after additional systemic therapy before randomization.

Cohort B Only

* Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.
* Subsequently underwent complete TURBT/resection of residual disease followed by additional systemic therapy.
* Achieved tumor-free status at the second response evaluation before randomization.

Exclusion Criteria

* Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.
* Has concurrent upper tract urothelial carcinoma.
* Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.
* Has received prior systemic immunotherapy for metastatic urothelial carcinoma.
* Has active autoimmune disease requiring systemic treatment.
* Is receiving systemic immunosuppressive therapy.
* Has uncontrolled infection requiring systemic therapy.
* Has another active malignancy requiring systemic treatment.
* Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.
* Has pregnancy or breastfeeding.
* Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.

Where it's running

• The Second Hospital of Tianjin Medical University
  Tianjin, China Recruiting
• General Hospital of Tianjin Medical University
  Tianjin, China Recruiting
• Tianjin Hospital
  Tianjin, China Recruiting
• Xingtai People's Hospital
  Xingtai, China Recruiting

Study contacts

• Principal investigator: Hailong Hu, MD — Department of Urology, The Second Hospital of Tianjin Medical University
• Study coordinator: Hailong Hu, MD
• Email: huhailong@tmu.edu.cn
• Phone: +8619801518556

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.