Trial · NCT06545955
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
NCT06545955, Phase 3, Recruiting, Ferring Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer. Trials, record NCT06545955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06545955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
- NCT number
- NCT06545955
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 250 participants, estimated
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
- Interventions
- Nadofaragene Firadenovec, Gemcitabine, Docetaxel, Pembrolizumab
- First posted
- 2024-08-09
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete response | up to 6 months | Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence). |
| Secondary | Complete response at month 3 | 3 months | Complete response 3 months from first treatment |
| Secondary | Complete response at month 6 | 6 months | Complete response 6 months from first treatment |
| Secondary | Durability of complete response | Up to 24 months | Durability of complete response (defined as time from achieved CR to HG recurrence, progression or death due to any cause). |
| Secondary | Muscle-invasive progression of disease | up to 36 months | Muscle-invasive progression of disease (defined as time from first treatment to first evidence of muscle-invasive disease or death) |
| Secondary | Cystectomy-free survival | up to 36 months | Cystectomy-free survival (defined as time from first treatment to either cystectomy or death due to any cause) |
| Secondary | Pathological staging | up to 36 months | Pathological staging (tumor, node, metastasis staging system) in participants at time of cystectomy |
| Secondary | Overall survival | up to 36 months | Overall survival (defined as time from first treatment to death due to any cause) |
| Secondary | Evidence of malignant lesions of the upper tract and/or prostatic urethra | up to 24 months | Evidence of malignant lesions of the upper tract and/or prostatic urethra (defined as time from first treatment to first evidence of malignant lesions). |
| Secondary | Adverse events | up to 36 months | Adverse events collected for nadofaragene firadenovec in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06545955
GET https://conductscience.org/api/trials/v1/NCT06545955/registered