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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04165317




Registration number
NCT04165317
Ethics application status
Date submitted
13/11/2019
Date registered
15/11/2019

Titles & IDs
Public title
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
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
Secondary ID [1] 0 0
2019-003375-19
Secondary ID [2] 0 0
B8011006
Universal Trial Number (UTN)
Trial acronym
CREST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-muscle Invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event free survival (Cohort A: Arm A compared to Arm C)
Timepoint [1] 0 0
55 months after first participant randomized
Primary outcome [2] 0 0
Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Timepoint [2] 0 0
Registration to 12 months after last participant initially assessed
Primary outcome [3] 0 0
Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
Timepoint [3] 0 0
Registration to 12 months after last participant initially assessed
Secondary outcome [1] 0 0
Event free survival (Cohort A: Arm B compared to Arm C)
Timepoint [1] 0 0
55 months after first participant randomized
Secondary outcome [2] 0 0
Overall Survival (Cohort A: Arm A compared to Arm C)
Timepoint [2] 0 0
Randomization up to 60 months from last participant randomized
Secondary outcome [3] 0 0
Overall Survival (Cohort A: Arm B compared to Arm C)
Timepoint [3] 0 0
Randomization up to 60 months from last participant randomized
Secondary outcome [4] 0 0
Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
Timepoint [4] 0 0
Randomization up to 60 months from last participant randomized
Secondary outcome [5] 0 0
Disease-specific survival (Cohort A: Arm A, B, C)
Timepoint [5] 0 0
Randomization up to 60 months from last participant randomized
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Randomization up to 60 months from last participant randomized
Secondary outcome [7] 0 0
ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Timepoint [7] 0 0
Randomization up to 24 months
Secondary outcome [8] 0 0
Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Timepoint [8] 0 0
Randomization up to 24 months
Secondary outcome [9] 0 0
Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
Timepoint [10] 0 0
Randomization/registration up to 60 months from last participant randomized
Secondary outcome [11] 0 0
Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
Timepoint [11] 0 0
Randomization up to 60 months from last participant randomized
Secondary outcome [12] 0 0
Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
Timepoint [12] 0 0
Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
Secondary outcome [13] 0 0
Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
Timepoint [13] 0 0
Randomization/registration up to 24 months
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
Baseline up to 60 months from the last participant randomized
Secondary outcome [15] 0 0
Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
Timepoint [15] 0 0
Baseline up to 60 months from last participant randomized
Secondary outcome [16] 0 0
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)
Timepoint [16] 0 0
Randomization/registration up to 60 months from the last participant randomized
Secondary outcome [17] 0 0
Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Timepoint [17] 0 0
12 months after last participant's initial assessment
Secondary outcome [18] 0 0
Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Timepoint [18] 0 0
Registration to 5 years after last participant randomized.
Secondary outcome [19] 0 0
Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Timepoint [19] 0 0
Registration to 5 years after last participant randomized.
Secondary outcome [20] 0 0
ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Timepoint [20] 0 0
Registration up to 24 months
Secondary outcome [21] 0 0
Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Timepoint [21] 0 0
Registration up to 24 months
Secondary outcome [22] 0 0
cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
Timepoint [22] 0 0
Registration up to 24 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2026
Actual
Sample size
Target
Accrual to date
Final
1070
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Southern Highlands Cancer Centre - Bowral
Recruitment hospital [2] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 0 0
Campbelltown Private Hospital - Campbelltown
Recruitment hospital [4] 0 0
Chris O'Brien Lifehouse Hospital - Camperdown
Recruitment hospital [5] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [8] 0 0
Yarra Ranges Health - Lilydale
Recruitment postcode(s) [1] 0 0
2756 - Bowral
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3140 - Lilydale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
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China
State/province [19] 0 0
Anhui
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China
State/province [20] 0 0
Beijing
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China
State/province [21] 0 0
Fujian
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Shaanxi
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China
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Sichuan
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China
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Zhejiang
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China
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Chongqing
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China
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Shanghai
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China
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Tianjin
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France
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Antony
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France
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Bayonne
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BORDEAUX Cedex
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France
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Brest Cedex 2
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Brest
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Limoges
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Muenster
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Germany
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Nuertingen
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Germany
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Tuebingen
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Italy
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Catania
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Milano
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Macerata
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Piotrkow Trybunalski
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Wroclaw
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Kaluzhskaya OBL.
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Other
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Russian Federation
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Republic OF Mordovia
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Chelyabinsk
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Ivanovo
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Kaluga
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Moscow
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Nizhny Novgorod
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Omsk
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Ryazan
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Saint Petersburg
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Ufa
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Vologda
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Yaroslavl
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Spain
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Barcelona
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Madrid
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Navarra
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Tarragona
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A Coruna
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Caceres
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Girona
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Lugo
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Valencia
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United Kingdom
State/province [114] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04165317