Trial · NCT02015104
Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG
NCT02015104, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG. Trials, record NCT02015104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02015104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG
- NCT number
- NCT02015104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Bladder Cancer
- Interventions
- BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)), PANVAC
- First posted
- 2013-12-19
- Last updated
- 2025-07-01
- Results first posted
- 2020-01-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months | Assessed from start of therapy to 6 and 12 months following therapy | RFS is defined as the time from the start of intravesical Bacillus Calmette-Guerin (TICE BCG) therapy (week 3) until disease recurrence or death due to any cause in each arm. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence. |
| Secondary | Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months | Assessed from start of therapy to 6 and 12 months following therapy | PFS is the duration of time from start of TICE BCG therapy (week 3) to time of progression or death due to any cause in each study arm, whichever occurs first. Progression is defined as upstaging from a lower stage to a higher stage (e.g., Ta to T1 or T1 to T2-4; or any N+ or M+ in these high grade tumors.).TNM Classification in non-muscle invasive bladder cancer: Ta = Non-invasive papillary carcinoma; T1 = Tumor invades the subepithelial connective tissue; T2-4 = size of primary tumor; N+ or M+ = lymph node involvement and metastasis. |
| Secondary | Time to Recurrence | Week 3 until recurrence or 12 months (whichever occurred first) | TTR is the duration of time measured from the start of TICE BCG therapy (week 3) until recurrence is noted. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a TURBT. Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence. |
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events | Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC Arm/Group, and 43 months and 12 days for BCG Alone Arm/Group. | Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Overall Survival (OS) | up to 50 months | OS is defined as the time from treatment start date until date of death or date last known alive. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months | Assessed from start of therapy to 6 and 12 months following therapy | One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months | Assessed from start of therapy to 6 and 12 months following therapy | One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group. | percentage of participants | NUMBER |
| SECONDARY | Time to Recurrence | Week 3 until recurrence or 12 months (whichever occurred first) | One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group. | Months | MEDIAN |
| SECONDARY | Number of Participants With Serious and Non-Serious Adverse Events | Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC Arm/Group, and 43 months and 12 days for BCG Alone Arm/Group. | One patient withdrew consent prior to treatment in the BCG Alone group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | up to 50 months | One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) + PANVAC | 6 months | 66 | 95% Confidence Interval 46.6 to 95.3 | percentage of participants |
| Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) Alone | 6 months | 60 | 95% Confidence Interval 39.5 to 90.7 | percentage of participants |
| Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) + PANVAC | 12 months | 44.4 | 95% Confidence Interval 24.8 to 79.7 | percentage of participants |
| Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) Alone | 12 months | 42.9 | 95% Confidence Interval 22.9 to 80.0 | percentage of participants |
| Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) + PANVAC | 6 months | 79 | 95% Confidence Interval 59.8 to 100 | percentage of participants |
| Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) Alone | 6 months | 93 | 95% Confidence Interval 80.3 to 100 | percentage of participants |
| Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) + PANVAC | 12 months | 78.5 | 95% Confidence Interval 59.8 to 100 | percentage of participants |
| Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months | Bacillus Calmette-Guerin (BCG) Alone | 12 months | 79.6 | 95% Confidence Interval 56.9 to 100 | percentage of participants |
| Time to Recurrence | Bacillus Calmette-Guerin (BCG) + PANVAC | 9.9 | 95% Confidence Interval 3.7 to NA | Months | |
| Time to Recurrence | Bacillus Calmette-Guerin (BCG) Alone | 11.7 | 95% Confidence Interval 4 to NA | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bacillus Calmette-Guerin (BCG) + PANVAC | 16 | |
| Overall Study | STARTED | Bacillus Calmette-Guerin (BCG) Alone | 16 | |
| Overall Study | COMPLETED | Bacillus Calmette-Guerin (BCG) + PANVAC | 15 | |
| Overall Study | COMPLETED | Bacillus Calmette-Guerin (BCG) Alone | 15 | |
| Overall Study | NOT COMPLETED | Bacillus Calmette-Guerin (BCG) + PANVAC | 1 | |
| Overall Study | NOT COMPLETED | Bacillus Calmette-Guerin (BCG) Alone | 1 |
Source ClinicalTrials.gov
Adverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | BCG + PANVAC | 1 | 15 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | BCG Alone | 0 | 15 | 0 |
| other | Anemia | Blood and lymphatic system disorders | BCG + PANVAC | 2 | 15 | 3 |
| other | Anemia | Blood and lymphatic system disorders | BCG Alone | 0 | 15 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | BCG + PANVAC | 1 | 15 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | BCG Alone | 0 | 15 | 0 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | BCG + PANVAC | 1 | 15 | 1 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | BCG Alone | 1 | 15 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | BCG + PANVAC | 1 | 15 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | BCG Alone | 0 | 15 | 0 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BCG + PANVAC | 3 | 15 |
| Total, all-cause mortality | BCG Alone | 2 | 15 |
| Total, other adverse events | BCG + PANVAC | 15 | 15 |
| Total, other adverse events | BCG Alone | 13 | 15 |
| Total, serious adverse events | BCG + PANVAC | 3 | 15 |
| Total, serious adverse events | BCG Alone | 3 | 15 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bacillus Calmette-Guerin (BCG) + PANVAC vs Bacillus Calmette-Guerin (BCG) Alone: Number of Participants With Serious and Non-Serious Adverse Events | Trial comparisons |
| BCG + PANVAC vs BCG Alone: deaths from any cause | Trial comparisons |
| BCG + PANVAC vs BCG Alone: serious adverse events | Trial comparisons |
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/NCT02015104
GET https://conductscience.org/api/trials/v1/NCT02015104/events?page=2