Trial · NCT04165317
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
NCT04165317, Phase 3, Active not recruiting, Pfizer; results first posted 2026-01-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer. Trials, record NCT04165317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04165317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
- NCT number
- NCT04165317
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,068 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- PF-06801591, Bacillus Calmette-Guerin
- First posted
- 2019-11-15
- Last updated
- 2026-10-15
- Results first posted
- 2026-01-22
- Limitations and caveats
Enrollment in Cohort B was closed based on sponsors decision; hence, the study objectives for Cohorts B1 and B2 were no longer required as pre-specified in the protocol; outcome measures for Cohorts B based on the data collected will be summarized and reported at the time of final analysis.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C | From randomization (Day 1) to first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks) | EFS: time from randomization till recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after complete response (CR) for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease, high-grade stage of bladder cancer (non-invasive papillary carcinoma \[Ta\] or invasion into the lamina propria without invasion into the muscularis propria \[T1\]) in participants with CIS only at baseline before achieving CR. Persistence of CIS: persistent CIS after induction, re-induction. EFS estimated using Kaplan-Meier analysis. |
| Secondary | Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C | From randomization (Day 1) to the first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks) | EFS: time from randomization till recurrence of high-grade disease, progression of disease, CIS, death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after CR for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease, high-grade stage of bladder cancer (non-invasive papillary carcinoma \[Ta\] or invasion into the lamina propria without invasion into the muscularis propria \[T1\]) in participants with CIS only at baseline before achieving CR. Persistence of CIS: persistent CIS after induction, re-induction. EFS estimated using Kaplan-Meier analysis. |
| Secondary | Cohort A: Overall Survival (OS) for Participants: Arm A Versus Arm C | From randomization (Day 1) until date of death due to any cause or censoring date | Overall survival was defined as the time in months from the date of randomization to the date of death due to any cause. Participants last known to be alive will be censored at the date of last contact |
| Secondary | Cohort A: OS of Participants: Arm B Versus Arm C | From randomization (Day 1) until date of death due to any cause or censoring date | Overall survival was defined as the time in months from the date of randomization to the date of death due to any cause. Participants last known to be alive will be censored at the date of last contact. |
| Secondary | Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set | From randomization (Day 1) to the first documented CR (maximum follow up duration was up to 257.1 weeks) | CR was defined as histologic disappearance of malignancy on bladder biopsy with negative cytology and cystoscopy or negative cytology and positive cystoscopy with biopsy-proven low-grade stage of bladder cancer defined as a non-invasive papillary carcinoma (Ta) lesion or non-malignant tissue for participants with CIS at randomization. 95% CI was based on Clopper-Pearson method. |
| Secondary | Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set | From date of first documentation of CR to date of an EFS event (maximum follow up duration was up to 257.1 weeks) | Duration of CR was defined as the time from the first documentation of CR to the date of an EFS event for participants with CR. EFS was defined as the time in months from randomization until recurrence of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first. CR was defined as histologic disappearance of malignancy on bladder biopsy with negative cytology and cystoscopy or negative cytology and positive cystoscopy with biopsy-proven low-grade stage of bladder cancer defined as a non-invasive papillary carcinoma (Ta) lesion or non-malignant tissue for participants with CIS at randomization. Kaplan-Meier method was used. 95% CI was estimated based on Brookmeyer and Crowley method. |
| Secondary | Cohort A: Time to Recurrence of Low-Grade Disease Assessed by the Investigator | From randomization (Day 1) to the date of positive biopsy, cystoscopy or cytology results (maximum follow up duration was up to 257.1 weeks) | Time to recurrence of low-grade disease was defined as the time from randomization to the date of first documentation of recurrence of low-grade disease. Recurrence of low-grade disease was defined as re-appearance of low-grade disease (low-grade Ta) after randomization based on positive biopsy, cystoscopy or cytology result. Kaplan-Meier method was used. 95% CI was estimated based on Brookmeyer and Crowley method. |
| Secondary | Cohort A: Time to Cystectomy | From randomization (Day 1) to date of cystectomy or censoring date | Time to cystectomy was defined as time from randomization to cystectomy. Participants without a cystectomy will be censored at death date or last date known to be alive. |
| Secondary | Cohort A: Disease Specific Survival (DSS) as Assessed by the Investigator | From randomization (Day 1) to the first documentation of death from bladder cancer | DSS was defined as the time from randomization to death resulting from bladder cancer, as assessed by the investigator. Participants last known to be alive will be censored at the date of last contact. |
| Secondary | Cohort A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C | From randomization (Day 1) to first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks) | Full analysis set (FAS) included all participants who were randomized in Cohort A. | Months | MEDIAN |
| SECONDARY | Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C | From randomization (Day 1) to the first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks) | FAS included all participants who were randomized in Cohort A. | Months | MEDIAN |
| SECONDARY | Cohort A: Overall Survival (OS) for Participants: Arm A Versus Arm C | From randomization (Day 1) until date of death due to any cause or censoring date | |||
| SECONDARY | Cohort A: OS of Participants: Arm B Versus Arm C | From randomization (Day 1) until date of death due to any cause or censoring date | |||
| SECONDARY | Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set | From randomization (Day 1) to the first documented CR (maximum follow up duration was up to 257.1 weeks) | FAS included all participants who were randomized in Cohort A. Here, Overall Number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set | From date of first documentation of CR to date of an EFS event (maximum follow up duration was up to 257.1 weeks) | FAS included all participants who were randomized in Cohort A. Here, Overall Number of Participants Analyzed included the participants with CIS at Baseline from FAS who achieved CR. | Months | MEDIAN |
| SECONDARY | Cohort A: Time to Recurrence of Low-Grade Disease Assessed by the Investigator | From randomization (Day 1) to the date of positive biopsy, cystoscopy or cytology results (maximum follow up duration was up to 257.1 weeks) | FAS included all participants who were randomized in Cohort A. | Months | MEDIAN |
| SECONDARY | Cohort A: Time to Cystectomy | From randomization (Day 1) to date of cystectomy or censoring date | Intent-to-treat (ITT) Population: all randomized participants | ||
| SECONDARY | Cohort A: Disease Specific Survival (DSS) as Assessed by the Investigator | From randomization (Day 1) to the first documentation of death from bladder cancer | Intent-to-treat (ITT) Population: all randomized participants | ||
| SECONDARY | Cohort A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | NA | 95% Confidence Interval NA to NA | Months | |
| Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C | Cohort A, Arm C: BCG (IND+MNT) | NA | 95% Confidence Interval NA to NA | Months | |
| Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C | Cohort A, Arm B: PF-06801591+BCG (IND) | 50.1 | 95% Confidence Interval 47.1 to NA | Months | |
| Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C | Cohort A, Arm C: BCG (IND+MNT) | NA | 95% Confidence Interval NA to NA | Months | |
| Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 89.8 | 95% Confidence Interval 81.5 to 95.2 | Percentage of participants | |
| Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set | Cohort A, Arm B: PF-06801591+BCG (IND) | 88.2 | 95% Confidence Interval 79.8 to 93.9 | Percentage of participants | |
| Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set | Cohort A, Arm C: BCG (IND+MNT) | 85.2 | 95% Confidence Interval 76.1 to 91.9 | Percentage of participants | |
| Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | NA | 95% Confidence Interval NA to NA | Months | |
| Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set | Cohort A, Arm B: PF-06801591+BCG (IND) | 44.6 | 95% Confidence Interval 44.6 to NA | Months | |
| Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set | Cohort A, Arm C: BCG (IND+MNT) | NA | 95% Confidence Interval 39.3 to NA | Months |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 352 | |
| Treatment Phase | STARTED | Cohort A, Arm B: PF-06801591+BCG (IND) | 352 | |
| Treatment Phase | STARTED | Cohort A, Arm C: BCG (IND+MNT) | 351 | |
| Treatment Phase | STARTED | Cohort B1: PF-06801591 300 mg | 5 | |
| Treatment Phase | STARTED | Cohort B2: PF-06801591 600 mg | 8 | |
| Treatment Phase | Treated | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 350 | |
| Treatment Phase | Treated | Cohort A, Arm B: PF-06801591+BCG (IND) | 348 | |
| Treatment Phase | Treated | Cohort A, Arm C: BCG (IND+MNT) | 349 | |
| Treatment Phase | Treated | Cohort B1: PF-06801591 300 mg | 5 | |
| Treatment Phase | Treated | Cohort B2: PF-06801591 600 mg | 8 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,535
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 | Anaemia | Blood and lymphatic system disorders | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 27 | 350 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A, Arm B: PF-06801591+BCG (IND) | 27 | 348 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A, Arm C: BCG (IND+MNT) | 13 | 349 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B1: PF-06801591 300 mg | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B2: PF-06801591 600 mg | 0 | 8 | |
| other | Hyperthyroidism | Endocrine disorders | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 30 | 350 | |
| other | Hyperthyroidism | Endocrine disorders | Cohort A, Arm B: PF-06801591+BCG (IND) | 29 | 348 | |
| other | Hyperthyroidism | Endocrine disorders | Cohort A, Arm C: BCG (IND+MNT) | 1 | 349 | |
| other | Hyperthyroidism | Endocrine disorders | Cohort B1: PF-06801591 300 mg | 0 | 5 | |
| other | Hyperthyroidism | Endocrine disorders | Cohort B2: PF-06801591 600 mg | 0 | 8 |
1 to 10 of 1,535Source ClinicalTrials.gov
See all 1,535 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 32 | 352 |
| Total, all-cause mortality | Cohort A, Arm B: PF-06801591+BCG (IND) | 30 | 352 |
| Total, all-cause mortality | Cohort A, Arm C: BCG (IND+MNT) | 29 | 351 |
| Total, all-cause mortality | Cohort B1: PF-06801591 300 mg | 0 | 5 |
| Total, all-cause mortality | Cohort B2: PF-06801591 600 mg | 0 | 8 |
| Total, other adverse events | Cohort A, Arm A: PF-06801591+BCG (IND+MNT) | 321 | 350 |
| Total, other adverse events | Cohort A, Arm B: PF-06801591+BCG (IND) | 299 | 348 |
| Total, other adverse events | Cohort A, Arm C: BCG (IND+MNT) | 287 | 349 |
| Total, other adverse events | Cohort B1: PF-06801591 300 mg | 5 | 5 |
| Total, other adverse events | Cohort B2: PF-06801591 600 mg | 7 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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/NCT04165317
GET https://conductscience.org/api/trials/v1/NCT04165317/results?page=2