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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04165317
Registration number
NCT04165317
Ethics application status
Date submitted
13/11/2019
Date registered
15/11/2019
Date last updated
5/04/2024
Titles & IDs
Public title
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
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Scientific title
A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC
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Secondary ID [1]
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2019-003375-19
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Secondary ID [2]
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B8011006
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Universal Trial Number (UTN)
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Trial acronym
CREST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-muscle Invasive Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-06801591
Treatment: Drugs - Bacillus Calmette-Guerin
Experimental: PF-06801591 + BCG induction and maintenance - PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
Experimental: PF-06801591 + BCG induction only - PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
Active Comparator: BCG induction and maintenance - Bacillus Calmette Guerin (induction and maintenance).
Experimental: BCG Unresponsive CIS - PF-06801591
Experimental: BCG Unresponsive NMIBC - PF-06801591
Treatment: Drugs: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Treatment: Drugs: Bacillus Calmette-Guerin
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event free survival (Cohort A: Arm A compared to Arm C)
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Assessment method [1]
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Event free survival is defined as the time from randomization to date of EFS event.
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Timepoint [1]
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55 months after first participant randomized
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Primary outcome [2]
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Event free survival (Cohort A: Arm B compared to Arm C)
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Assessment method [2]
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Event free survival is defined as the time from randomization to date of EFS event.
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Timepoint [2]
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55 months after first participant randomized
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Primary outcome [3]
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Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [3]
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Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
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Timepoint [3]
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Registration to 12 months after last participant initially assessed
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Primary outcome [4]
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Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [4]
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Event free survival is defined as the time from first dose to date of EFS event.
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Timepoint [4]
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Registration to 12 months after last participant initially assessed
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Secondary outcome [1]
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Overall Survival (Cohort A: Arm A compared to Arm C)
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Assessment method [1]
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Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Randomization up to 60 months from last participant randomized
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Secondary outcome [2]
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Overall Survival (Cohort A: Arm B compared to Arm C)
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Assessment method [2]
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Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [2]
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Randomization up to 60 months from last participant randomized
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Secondary outcome [3]
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Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
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Assessment method [3]
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Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
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Timepoint [3]
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Randomization up to 60 months from last participant randomized
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Secondary outcome [4]
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Disease-specific survival (Cohort A: Arm A, B, C)
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Assessment method [4]
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Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
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Timepoint [4]
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Randomization up to 60 months from last participant randomized
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Secondary outcome [5]
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Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire for cancer patients) (Obsolete for Cohort B after stopping enrollment)
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Assessment method [5]
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
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Timepoint [5]
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Randomization up to 60 months from last participant randomized
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Secondary outcome [6]
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ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
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Assessment method [6]
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Ctrough will be summarized in Cohort A Arms A and B only.
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Timepoint [6]
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Randomization up to 24 months
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Secondary outcome [7]
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Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
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Assessment method [7]
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Immunogenicity will be evaluated for Cohort A Arms A and B only.
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Timepoint [7]
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Randomization up to 24 months
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Secondary outcome [8]
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Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
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Assessment method [8]
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Evaluate PD-L1 expression.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
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Assessment method [9]
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Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.
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Timepoint [9]
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Randomization/registration up to 60 months from last participant randomized
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Secondary outcome [10]
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Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
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Assessment method [10]
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Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.
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Timepoint [10]
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Randomization up to 60 months from last participant randomized
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Secondary outcome [11]
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Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
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Assessment method [11]
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Time to cystectomy is defined as time from randomization/registration to cystectomy in participants with NMIBC
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Timepoint [11]
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Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
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Secondary outcome [12]
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Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
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Assessment method [12]
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PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).
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Timepoint [12]
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Randomization/registration up to 24 months
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Secondary outcome [13]
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Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs (Obsolete for Cohort B after stopping enrollment)
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Assessment method [13]
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An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
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Timepoint [13]
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Baseline up to 60 months from the last participant randomized
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Secondary outcome [14]
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Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
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Assessment method [14]
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Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
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Timepoint [14]
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Baseline up to 60 months from last participant randomized
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Secondary outcome [15]
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Health-related quality of life as measured by EORTC QLQ-NMIBC24 (European Organization for Treatment of Cancer in patients with non-muscle invasion bladder cancer) (Obsolete for Cohort B after stopping enrollment)
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Assessment method [15]
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EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).
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Timepoint [15]
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Randomization/registration up to 60 months from the last participant randomized
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Secondary outcome [16]
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Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [16]
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Complete response (CR) rate defined as the proportion of participants in the analysis population with CR at 12 months.
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Timepoint [16]
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12 months after last participant's initial assessment
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Secondary outcome [17]
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Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [17]
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Time from first dose to date of EFS event.
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Timepoint [17]
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Registration to 5 years after last participant randomized.
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Secondary outcome [18]
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Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [18]
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Time from the date of first dose to the date of death due to any cause.
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Timepoint [18]
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Registration to 5 years after last participant randomized.
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Secondary outcome [19]
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ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [19]
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Ctrough will be summarized
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Timepoint [19]
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Registration up to 24 months
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Secondary outcome [20]
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Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [20]
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Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.
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Timepoint [20]
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Registration up to 24 months
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Secondary outcome [21]
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cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
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Assessment method [21]
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Cmax will be summarized in Cohort B2 only.
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Timepoint [21]
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Registration up to 24 months
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Eligibility
Key inclusion criteria
- Histological confirmed diagnosis of high risk non-muscle invasive transitional cell
carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed
transitional/non-transitional cell histology are allowed, but TCC must be the
predominant histology)
- Complete resection of all Ta/T1 papillary disease (including participants with
concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to
randomization or study intervention. A second TURBT must have been performed if
indicated according to the current locally applicable guidelines, ie, American
Urological Association, European Association of Urology
- (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive
high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6
months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
- Have refused or are ineligible for radical cystectomy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or
concurrent extravesical, non-muscle invasive TCC of the urothelium
- (Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior
intravesical chemotherapy for NMIBC is allowed.
(Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from
the time of most recent positive TURBT to initiation of study intervention.
- Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody
- Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15,
interferon (INF)
- Prior radiation therapy to the bladder
- (Cohorts B1 and B2 only): Prior participation in Cohort A of this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
1070
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Southern Highlands Cancer Centre - Bowral
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Recruitment hospital [2]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
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Campbelltown Private Hospital - Campbelltown
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Recruitment hospital [4]
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Chris O'Brien Lifehouse Hospital - Camperdown
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Recruitment hospital [5]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [6]
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Box Hill Hospital - Box Hill
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Recruitment hospital [7]
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Eastern Clinical Research Unit - Box Hill
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Recruitment hospital [8]
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Yarra Ranges Health - Lilydale
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Recruitment postcode(s) [1]
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2756 - Bowral
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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2050 - Camperdown
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3140 - Lilydale
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Illinois
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Louisiana
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Gent
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Japan
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State/province [69]
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Kagoshima
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Japan
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Kumamoto
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Japan
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Okayama
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Japan
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Yamagata
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Country [73]
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Poland
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State/province [76]
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Belchatow
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Country [77]
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Poland
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State/province [77]
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Gliwice
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Country [78]
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Poland
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Grudziadz
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Country [79]
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Poland
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State/province [79]
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Myslowice
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Country [80]
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Poland
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State/province [80]
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Piotrkow Trybunalski
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Country [81]
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Poland
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Poznan
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Country [82]
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Poland
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State/province [82]
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Skierniewice
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Poland
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State/province [83]
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Warszawa
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Country [84]
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Poland
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State/province [84]
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Wroclaw
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Country [85]
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Russian Federation
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State/province [85]
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Kaluzhskaya OBL.
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Country [86]
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Russian Federation
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State/province [86]
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Other
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Country [87]
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Russian Federation
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State/province [87]
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Republic OF Mordovia
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Country [88]
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Russian Federation
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State/province [88]
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Saint-petersburg
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Country [89]
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Russian Federation
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State/province [89]
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Stavropolskiy KRAI
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Country [90]
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Russian Federation
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State/province [90]
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Vsevolozhskiy District
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Country [91]
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Russian Federation
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State/province [91]
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Vsevolozhsky District
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Country [92]
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Russian Federation
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State/province [92]
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Chelyabinsk
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Country [93]
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Russian Federation
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State/province [93]
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Ivanovo
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Country [94]
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Russian Federation
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State/province [94]
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Kaliningrad
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Country [95]
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Russian Federation
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Kaluga
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Country [96]
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Russian Federation
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State/province [96]
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Moscow
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Country [97]
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Russian Federation
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Nizhny Novgorod
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Country [98]
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Russian Federation
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State/province [98]
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Omsk
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Country [99]
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Russian Federation
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State/province [99]
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Ryazan
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Country [100]
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Russian Federation
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State/province [100]
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Saint Petersburg
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Country [101]
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Russian Federation
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State/province [101]
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Saint-Petersburg
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Country [102]
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Russian Federation
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State/province [102]
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Ufa
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Country [103]
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Russian Federation
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State/province [103]
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Vologda
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Country [104]
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Russian Federation
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State/province [104]
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Yaroslavl
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Country [105]
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Spain
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State/province [105]
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Barcelona
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Country [106]
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Spain
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State/province [106]
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Madrid
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Country [107]
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Spain
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State/province [107]
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Navarra
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Country [108]
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Spain
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State/province [108]
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Tarragona
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Country [109]
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Spain
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State/province [109]
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A Coruna
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Country [110]
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Spain
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State/province [110]
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Caceres
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Country [111]
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Spain
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State/province [111]
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Girona
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Country [112]
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Spain
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State/province [112]
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Lugo
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Country [113]
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Spain
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State/province [113]
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Valencia
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Country [114]
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United Kingdom
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State/province [114]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to learn about the safety and effects of the study medicine
(sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking
participants whose bladder cancer is still in early stages, has not spread outside of the
bladder, has been removed with surgery, and is high risk (Part A) or was previously treated
with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).
In Part A (enrollment closed), each participant was assigned to one of three study treatment
groups.
- One group is given sasanlimab and BCG at the study clinic.
- The second group is given sasanlimab and BCG at the study clinic. This group will
receive BCG for the first six weeks only.
- The third group is given BCG only and will not receive sasanlimab.
In Part B of the study, each new participant will be assigned to a study treatment group
based on the type of their bladder tumor.
- Both groups will be given sasanlimab at the study clinic.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The
decision to discontinue enrollment to Part B was not made for safety reasons.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04165317
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04165317
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