Trial · NCT02773849
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
NCT02773849, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2022-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Trials, record NCT02773849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02773849
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
- NCT number
- NCT02773849
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 157 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Superficial Bladder Cancer
- Interventions
- ADSTILADRIN
- First posted
- 2016-05-16
- Last updated
- 2024-07-29
- Results first posted
- 2022-07-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With a Complete Response Rate Based on Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease. | 12 Months | A patient in the CIS cohort was judged to have achieved CR where urine cytology was reported as normal, atypical, degenerative, reactive, inflammatory, or nonspecific AND cystoscopy was reported as normal or with findings that did not include evidence of low-grade or high-grade recurrence. Bladder biopsy, if performed (not mandatory), demonstrated an absence of low-grade or high-grade recurrence. |
| Secondary | Durability of Complete Response in Patients With CIS (With or Without Concomitant Ta or T1 Papillary Disease) Who Achieve a Complete Response. | Up to 57 months | Durability of complete response (CR) was defined as the time from first observed CR to the documented treatment failure. Patients without treatment failure were censored at the last disease assessment not showing treatment failure, where treatment failure was defined as high-grade disease recurrence, disease progression, or death, whichever occurred earlier. |
| Secondary | Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | up to 57 months | Complete response rate will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder. Incidence of HGRF survival at Months 3, 6, 9, and 12, and every 3 months up to Month 24, and then at Months 36, 48, and 57. |
| Secondary | Durability of High-grade-recurrence-free Survival in Patients With High-grade Ta or T1 Papillary Disease (With or Without Concomitant CIS) | Up to 57 months | HGRF survival was defined as the time from the first dose to the first recurrence of high-grade disease (including muscle-invasive disease progression and death due to any cause). Patients without high-grade disease recurrence were censored at the last disease assessment not showing high-grade disease recurrence. |
| Secondary | Incidence of Cystectomy at 12 Months, 2 Years and 5 Years | 60 Months | The incidence of cystectomy is described as the proportion of patients undergoing radical cystectomy for any reason after the first dose, within 12 months, 2 years and 5 years. |
| Secondary | Overall Survival Rate in All Patients | 60 Months | Overall survival rate was defined as the time from the first dose to death due to any cause. Patients who were still alive were censored at the last date the patient was known to be alive. Overall survival rate is a Kaplan-Meier estimate of the survivor function at each specific time point. The 95% CI is calculated using the Greenwood's formula with a log-log transformation. Percentage is calculated using the number of patients in the column heading as the denominator. |
| Secondary | Anti-adenoviral Antibody Levels for Correlation to Response Rate | 12 Months | Measurement of anti-adenoviral antibody levels at each dosing period, withdrawal, and at 12 months were done. A patient was considered to have a positive immunogenic response in anti-adenoviral antibodies if a post-baseline titration demonstrated a greater than a 2-fold dilution increase from baseline. The table represent data at any time during the 12 months period, which means that the patients were included in the Yes group if they at any measurement during the trial had a 2-fold dilution increase from baseline. |
| Secondary | Safety of ADSTILADRIN | 60 Months | The type, incidence, relatedness and severity of treatment emergent adverse events of ADSTILADRIN as assessed by NCI-CTCAE V4.03 were monitored. |
| Secondary | Durability of Response During the Long-term Follow-up Period. | Up to 60 Months | Durability will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder if clinically indicated. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With a Complete Response Rate Based on Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease. | 12 Months | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | Durability of Complete Response in Patients With CIS (With or Without Concomitant Ta or T1 Papillary Disease) Who Achieve a Complete Response. | Up to 57 months | Patients who achieved CR | Months | MEDIAN |
| SECONDARY | Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | up to 57 months | A patient was judged to have achieved HGRF survival at a time point (eg, Months 3, 6, 9, and 12) if the patient was alive and without documented recurrence of high-grade disease or muscle-invasive disease progression as assessed by the Investigator at that time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Durability of High-grade-recurrence-free Survival in Patients With High-grade Ta or T1 Papillary Disease (With or Without Concomitant CIS) | Up to 57 months | Patients with no recurrence of high-grade disease | Months | MEDIAN |
| SECONDARY | Incidence of Cystectomy at 12 Months, 2 Years and 5 Years | 60 Months | Proportion of patients undergoing cystectomy within 5 years, 2 years and 12 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival Rate in All Patients | 60 Months | percentage of patients | NUMBER | |
| SECONDARY | Anti-adenoviral Antibody Levels for Correlation to Response Rate | 12 Months | Patients with Positive Immunogenic Response in Anti-Adenoviral Antibodies at Post-Baseline based on patients who had achieved High-Grade Recurrence Free Survival at 12 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety of ADSTILADRIN | 60 Months | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Durability of Response During the Long-term Follow-up Period. | Up to 60 Months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With a Complete Response Rate Based on Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease. | Carcinoma in Situ | 55 | 95% Confidence Interval 43.3 to 63.3 | participants | |
| Durability of Complete Response in Patients With CIS (With or Without Concomitant Ta or T1 Papillary Disease) Who Achieve a Complete Response. | Carcinoma in Situ | 9.72 | 95% Confidence Interval 9.17 to 23.95 | Months | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 3 | 35 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 6 | 30 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 9 | 28 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 12 | 21 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 24 | 16 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 36 | 11 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 48 | 7 | Participants | |
| Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS) | Papillary Disease | Month 57 | 7 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ADSTILADRIN | 157 | |
| Overall Study | COMPLETED | ADSTILADRIN | 95 | |
| Overall Study | NOT COMPLETED | ADSTILADRIN | 62 |
Source ClinicalTrials.gov
Adverse events186
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 | Carcinoma in Situ (CIS) | 2 | 107 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Papillary Disease (Without Concomitant CIS) | 5 | 50 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Total TEAE | 7 | 157 | 7 |
| other | Constipation | Gastrointestinal disorders | Carcinoma in Situ (CIS) | 0 | 107 | 0 |
| other | Constipation | Gastrointestinal disorders | Papillary Disease (Without Concomitant CIS) | 3 | 50 | 3 |
| other | Constipation | Gastrointestinal disorders | Total TEAE | 3 | 157 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Carcinoma in Situ (CIS) | 10 | 107 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Papillary Disease (Without Concomitant CIS) | 7 | 50 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Total TEAE | 17 | 157 | 17 |
| other | Nausea | Gastrointestinal disorders | Carcinoma in Situ (CIS) | 8 | 107 | 8 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carcinoma in Situ (CIS) | 21 | 107 |
| Total, all-cause mortality | Papillary Disease (Without Concomitant CIS) | 5 | 50 |
| Total, all-cause mortality | Total TEAE | 26 | 157 |
| Total, other adverse events | Carcinoma in Situ (CIS) | 101 | 107 |
| Total, other adverse events | Papillary Disease (Without Concomitant CIS) | 45 | 50 |
| Total, other adverse events | Total TEAE | 146 | 157 |
| Total, serious adverse events | Carcinoma in Situ (CIS) | 10 | 107 |
| Total, serious adverse events | Papillary Disease (Without Concomitant CIS) | 9 | 50 |
| Total, serious adverse events | Total TEAE | 19 | 157 |
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 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/NCT02773849
GET https://conductscience.org/api/trials/v1/NCT02773849/results?page=2