The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Sasanlimab is an investigational compound. Its safety and efficacy have not been established.
Active Not-enrolling
United States, Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: PF-06801591 + BCG induction and maintenance
PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
DRUG: Bacillus Calmette-Guerin
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
EXPERIMENTAL: PF-06801591 + BCG induction only
PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
DRUG: Bacillus Calmette-Guerin
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
ACTIVE_COMPARATOR: BCG induction and maintenance
Bacillus Calmette Guerin (induction and maintenance).
DRUG: Bacillus Calmette-Guerin
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
EXPERIMENTAL: BCG Unresponsive CIS
PF-06801591
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
EXPERIMENTAL: BCG Unresponsive NMIBC
PF-06801591
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
(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.
Event free survival (Cohort A: Arm A compared to Arm C)
Event free survival is defined as the time from randomization to date of EFS event.
55 months after first participant randomized
Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Registration to 12 months after last participant initially assessed
Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
Event free survival is defined as the time from first dose to date of EFS event.
Registration to 12 months after last participant initially assessed
Event free survival (Cohort A: Arm B compared to Arm C)
Event free survival is defined as the time from randomization to date of EFS event.
55 months after first participant randomized
Overall Survival (Cohort A: Arm A compared to Arm C)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Randomization up to 60 months from last participant randomized
Overall Survival (Cohort A: Arm B compared to Arm C)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Randomization up to 60 months from last participant randomized
Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Randomization up to 60 months from last participant randomized
Disease-specific survival (Cohort A: Arm A, B, C)
Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
Randomization up to 60 months from last participant randomized
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)
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).
Randomization up to 60 months from last participant randomized
ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Ctrough will be summarized in Cohort A Arms A and B only.
Randomization up to 24 months
Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Immunogenicity will be evaluated for Cohort A Arms A and B only.
Randomization up to 24 months
Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
Evaluate PD-L1 expression.
Baseline
Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.
Randomization/registration up to 60 months from last participant randomized
Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
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.
Randomization up to 60 months from last participant randomized
Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
Time to cystectomy is defined as time from randomization/registration to cystectomy in participants with NMIBC
Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
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).
Randomization/registration up to 24 months
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)
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.
Baseline up to 60 months from the last participant randomized
Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
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.
Baseline up to 60 months from last participant randomized
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)
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).
Randomization/registration up to 60 months from the last participant randomized
Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR at 12 months.
12 months after last participant's initial assessment
Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Time from first dose to date of EFS event.
Registration to 5 years after last participant randomized.
Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Time from the date of first dose to the date of death due to any cause.
Registration to 5 years after last participant randomized.
ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Ctrough will be summarized
Registration up to 24 months
Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.
Registration up to 24 months
cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
Cmax will be summarized in Cohort B2 only.
Registration up to 24 months
1070
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT04165317
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