Clinical trial · Interventional
A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| NMIBC | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| Non-Muscle Invasive Bladder Urothelial Carcinoma | Non-Muscle Invasive Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma Bladder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG (TICE strain) | Drug | — | UNRESOLVED |
| Gemcitabine + BCG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intravesical Gemcitabine + BCG
- description
- Patients will be recruited to treatment with gemcitabine at week 0 following which BCG (50 mg, TICE strain) will be administered once every week for a total of 5 instillations.
- interventionNames
- Drug: Gemcitabine + BCG
- type
- ACTIVE_COMPARATOR
- label
- Intravesical Bacillus Calmette-Guérin (BCG)
- description
- 6 intravesical instillations of BCG (50 mg, TICE strain) at weekly intervals.
- interventionNames
- Drug: BCG (TICE strain)
Primary outcomes (1)
- measure
- BCG ImmunoScore
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive). * Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS. * Participants older than 65 years of age. Exclusion Criteria: * Patients with prior exposure to BCG immunotherapy. * Immunosuppressed patients on steroids, transplants etc.
References
Publications (0)
Data not yet available