Study of Sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer

NCT04165317

Last updated date
Study Location
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-muscle Invasive Bladder Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 TURBT occurring within 12 weeks prior to randomization. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or
concurrent extravesical, non-muscle invasive TCC of the urothelium


- Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical
chemotherapy for NMIBC is allowed


- 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

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Non-muscle Invasive Bladder CancerStudy of Sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer
NCT04165317
  1. Little Rock, Arkansas
  2. Little Rock, Arkansas
  3. Montreal, Quebec
  4. Beijing, Beijing
  5. Fuzhou, Fujian
  6. Reggio Emilia,
  7. Tucson, Arizona
  8. Tucson, Arizona
  9. Orange, California
  10. Hialeah, Florida
  11. Jacksonville, Florida
  12. Jacksonville, Florida
  13. Riverview, Florida
  14. Tampa, Florida
  15. Chicago, Illinois
  16. Chicago, Illinois
  17. Lisle, Illinois
  18. Lombard, Illinois
  19. Naperville, Illinois
  20. Shreveport, Louisiana
  21. Shreveport, Louisiana
  22. Hanover, Maryland
  23. Troy, Michigan
  24. Bronx, New York
  25. Bronx, New York
  26. New York, New York
  27. New York, New York
  28. New York, New York
  29. New York, New York
  30. New York, New York
  31. New York, New York
  32. Poughkeepsie, New York
  33. Poughkeepsie, New York
  34. Syracuse, New York
  35. Cleveland, Ohio
  36. Cleveland, Ohio
  37. Myrtle Beach, South Carolina
  38. Myrtle Beach, South Carolina
  39. Dallas, Texas
  40. Dallas, Texas
  41. Houston, Texas
  42. Houston, Texas
  43. San Antonio, Texas
  44. Norfolk, Virginia
  45. Virginia Beach, Virginia
  46. Bowral, New South Wales
  47. Camperdown, New South Wales
  48. Box Hill, Victoria
  49. Box Hill, Victoria
  50. Clayton, Victoria
  51. Lilydale, Victoria
  52. Gent,
  53. Kortrijk,
  54. Kingston, Ontario
  55. Kingston, Ontario
  56. Kingston, Ontario
  57. Toronto, Ontario
  58. Toronto, Ontario
  59. Chicoutimi, Quebec
  60. Montreal, Quebec
  61. Quebec,
  62. Quebec,
  63. Beijing, Beijing
  64. Beijing, Beijing
  65. Wuhan, Hubei
  66. Nantong, Jiangsu
  67. Suzhou, Jiangsu
  68. Hangzhou, Zhejiang
  69. Wenzhou, Zhejiang
  70. Wenzhou, Zhejiang
  71. Chongqing,
  72. Shanghai,
  73. Antony,
  74. Antony,
  75. Bayonne,
  76. BORDEAUX Cedex,
  77. Bordeaux Cedex,
  78. Bordeaux,
  79. Brest Cedex 2,
  80. Brest,
  81. Brest,
  82. Clermont-Ferrand,
  83. Lille,
  84. Limoges Cedex 1,
  85. Limoges,
  86. Nancy,
  87. Paris,
  88. Strasbourg,
  89. Frankfurt,
  90. Muenster,
  91. Nuertingen,
  92. Tuebingen,
  93. Misterobianco (CT), Catania
  94. Cremona, CR
  95. Rozzano, Milano
  96. Torino, Turin
  97. Arezzo,
  98. Bari,
  99. Macerata,
  100. Messina,
  101. Milan,
  102. Varese,
  103. Matsuyama, Ehime
  104. Toon, Ehime
  105. Fukuoka-shi, Fukuoka
  106. Ota, Gunma
  107. Sapporo, Hokkaido
  108. Yokohama, Kanagawa
  109. Niigata-shi, Niigata
  110. Osaka-shi, Osaka
  111. Hamamatsu, Shizuoka
  112. Shinjuku-ku, Tokyo
  113. Kagoshima,
  114. Kumamoto,
  115. Okayama,
  116. Yamagata,
  117. Goyang-si, Gyeonggi-do
  118. Seongnam-si, Gyeonggi-do
  119. Daegu,
  120. Seoul,
  121. Seoul,
  122. Seoul,
  123. Seoul,
  124. Gliwice,
  125. Grudziadz,
  126. Mysłowice,
  127. Piotrkow Trybunalski,
  128. Poznan,
  129. Rumia,
  130. Skierniewice,
  131. Warszawa,
  132. Warszawa,
  133. Wroclaw,
  134. Obninsk, Kaluzhskaya OBL.
  135. Saransk, Republic OF Mordovia
  136. Pushkin, Saint-petersburg
  137. Pyatigorsk, Stavropolskiy KRAI
  138. Kuzmolovsky Settlement, Vsevolozhsky District
  139. Chelyabinsk,
  140. Ivanovo,
  141. Kaliningrad,
  142. Kaluga,
  143. Moscow,
  144. Nizhny Novgorod,
  145. Omsk,
  146. Ryazan,
  147. Saint-Petersburg,
  148. Saint-Petersburg,
  149. Ufa,
  150. Vologda,
  151. Yaroslavl,
  152. Badalona, Barcelona
  153. Granollers, Barcelona
  154. L'Hospitalet de Llobregat, Barcelona
  155. L'Hospitalet de Llobregat, Barcelona
  156. Pamplona, Navarra
  157. Reus, Tarragona
  158. A Coruna,
  159. Barcelona,
  160. Barcelona,
  161. Barcelona,
  162. Caceres,
  163. Girona,
  164. Lugo,
  165. Madrid,
  166. Madrid,
  167. Madrid,
  168. Valencia,
  169. Valencia,
  170. London,
  171. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer
Official Title  ICMJE 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
Brief Summary

CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment

Phase 3 Design with 3 study Arms (A, B and C). Arms A and B consists of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG.

The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-muscle Invasive Bladder Cancer
Intervention  ICMJE
  • Drug: PF-06801591
    A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
    Other Name: Sasanlimab
  • Drug: Bacillus Calmette-Guerin
    Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
    Other Name: BCG
Study Arms  ICMJE
  • Experimental: PF-06801591 + BCG induction and maintenance
    PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
    Interventions:
    • Drug: PF-06801591
    • Drug: Bacillus Calmette-Guerin
  • Experimental: PF-06801591 + BCG induction only
    PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
    Interventions:
    • Drug: PF-06801591
    • Drug: Bacillus Calmette-Guerin
  • Active Comparator: BCG induction and maintenance
    Bacillus Calmette Guerin (induction and maintenance).
    Intervention: Drug: Bacillus Calmette-Guerin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
999
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 21, 2026
Estimated Primary Completion Date June 3, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 TURBT occurring within 12 weeks prior to randomization. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology

Exclusion Criteria:

  • Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
  • Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   China,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT04165317
Other Study ID Numbers  ICMJE B8011006
2019-003375-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP