Trial · NCT02138734
A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
NCT02138734, Phase 1, Phase 2, Active not recruiting, ImmunityBio, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer. Trials, record NCT02138734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02138734
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
- NCT number
- NCT02138734
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 369 participants, actual
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- BCG (50mg/instillation) + N-803 (400 μg/instillation), BCG (50mg/instillation)
- First posted
- 2014-05-15
- Last updated
- 2026-03-31
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate | 6 Months | Patients in Cohort A: compare complete response rate between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology. |
| Primary | Disease Free Survival (DFS) | 13 Years and 3 Months | Patients in Cohort B: compare disease-free survival between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology. |
| Secondary | Progression-free survival (PFS) | 13 Years and 3 Months | For phase IIb, Cohorts A \& B: Time from randomization to disease progression or death. |
| Secondary | Overall survival | 13 Years and 3 months | Time from randomization to death resulting from any cause to determine survival. |
| Secondary | Disease specific survival | 13 Years and 3 months | For phase IIb, Cohorts A \& B: Time from randomization to death resulting from bladder cancer. |
| Secondary | Time to disease worsening | 13 Years and 3 Months | For phase IIb, Cohorts A \& B: Cystectomy or change in therapy indicative of more advanced disease, including systemic chemotherapy or radiation therapy. |
| Secondary | Cystectomy Free Rate | 13 years and 3 months | Cystectomy-free rate will be calculated for each treatment group as the ratio of the number of subjects who don't have documented cystectomy in the database divided by the number of subjects in the ITT (Intent to treat) population. |
| Secondary | Safety Profile: Number and severity of treatment emergent AEs [Time Frame: 39 Months] | 39 Months | For phase Ib and phase IIb: Number of participants with TEAEs as assessed by CTCAE v4.03. |
| Secondary | Duration of Complete Response | 13 Years and 3 months | To assess the duration of CR of patients treated with N-803 plus BCG compared to patients treated with BCG alone. |
| Secondary | Complete Response Rate( All Recurrent Bladder Cancer Including Low Grade Ta Disease) | 13 Years and 3 months | To assess the CR rate (all recurrent bladder cancer including low grade Ta disease) of patients treated with N-803 plus BCG compared to patients treated with BCG alone. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38953850 | DERIVED |
Source PubMed
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/NCT02138734
GET https://conductscience.org/api/trials/v1/NCT02138734/registered