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.

Clinical Trial Details

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Genitourinary Cancer

Sasanlimab

Sasanlimab is an investigational compound. Its safety and efficacy have not been established.

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
Phase 3
NCT04165317

Active Not-enrolling

Globe
Locations

United States, Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom

Study design

Participant Group/Arm

EXPERIMENTAL: PF-06801591 + BCG induction and maintenance

PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).

Intervention/Treatment

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

Participant Group/Arm

EXPERIMENTAL: PF-06801591 + BCG induction only

PF-06801591 in combination with Bacillus Calmette Guerin (induction only).

Intervention/Treatment

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

Participant Group/Arm

ACTIVE_COMPARATOR: BCG induction and maintenance

Bacillus Calmette Guerin (induction and maintenance).

Intervention/Treatment

DRUG: Bacillus Calmette-Guerin

Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer

Participant Group/Arm

EXPERIMENTAL: BCG Unresponsive CIS

PF-06801591

Intervention/Treatment

DRUG: PF-06801591

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.

Participant Group/Arm

EXPERIMENTAL: BCG Unresponsive NMIBC

PF-06801591

Intervention/Treatment

DRUG: PF-06801591

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.

Key eligibility criteria

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
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.

Key dates

Study start date
  • December 2019
Estimated primary completion date
  • December 2026

Key endpoints

Primary Outcome Measures
Outcome Measure

Event free survival (Cohort A: Arm A compared to Arm C)

Measure Description

Event free survival is defined as the time from randomization to date of EFS event.

Time Frame

55 months after first participant randomized

Outcome Measure

Event free survival (Cohort A: Arm B compared to Arm C)

Measure Description

Event free survival is defined as the time from randomization to date of EFS event.

Time Frame

55 months after first participant randomized

Outcome Measure

Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.

Time Frame

Registration to 12 months after last participant initially assessed

Outcome Measure

Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Event free survival is defined as the time from first dose to date of EFS event.

Time Frame

Registration to 12 months after last participant initially assessed

Secondary Outcome Measures:
Outcome Measure

Overall Survival (Cohort A: Arm A compared to Arm C)

Measure Description

Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

Time Frame

Randomization up to 60 months from last participant randomized

Outcome Measure

Overall Survival (Cohort A: Arm B compared to Arm C)

Measure Description

Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

Time Frame

Randomization up to 60 months from last participant randomized

Outcome Measure

Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)

Measure Description

Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.

Time Frame

Randomization up to 60 months from last participant randomized

Outcome Measure

Disease-specific survival (Cohort A: Arm A, B, C)

Measure Description

Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.

Time Frame

Randomization up to 60 months from last participant randomized

Outcome Measure

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)

Measure Description

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).

Time Frame

Randomization up to 60 months from last participant randomized

Outcome Measure

ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.

Measure Description

Ctrough will be summarized in Cohort A Arms A and B only.

Time Frame

Randomization up to 24 months

Outcome Measure

Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.

Measure Description

Immunogenicity will be evaluated for Cohort A Arms A and B only.

Time Frame

Randomization up to 24 months

Outcome Measure

Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)

Measure Description

Evaluate PD-L1 expression.

Time Frame

Baseline

Outcome Measure

Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)

Measure Description

Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.

Time Frame

Randomization/registration up to 60 months from last participant randomized

Outcome Measure

Time to recurrence of low grade disease (Cohort A: Arm A, B, C)

Measure Description

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.

Time Frame

Randomization up to 60 months from last participant randomized

Outcome Measure

Time to cystectomy (Obsolete for Cohort B after stopping enrollment)

Measure Description

Time to cystectomy is defined as time from randomization/registration to cystectomy in participants with NMIBC

Time Frame

Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)

Outcome Measure

Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)

Measure Description

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).

Time Frame

Randomization/registration up to 24 months

Outcome Measure

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)

Measure Description

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.

Time Frame

Baseline up to 60 months from the last participant randomized

Outcome Measure

Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)

Measure Description

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.

Time Frame

Baseline up to 60 months from last participant randomized

Outcome Measure

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)

Measure Description

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).

Time Frame

Randomization/registration up to 60 months from the last participant randomized

Outcome Measure

Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Complete response (CR) rate defined as the proportion of participants in the analysis population with CR at 12 months.

Time Frame

12 months after last participant's initial assessment

Outcome Measure

Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Time from first dose to date of EFS event.

Time Frame

Registration to 5 years after last participant randomized.

Outcome Measure

Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Time from the date of first dose to the date of death due to any cause.

Time Frame

Registration to 5 years after last participant randomized.

Outcome Measure

ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Ctrough will be summarized

Time Frame

Registration up to 24 months

Outcome Measure

Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.

Time Frame

Registration up to 24 months

Outcome Measure

cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)

Measure Description

Cmax will be summarized in Cohort B2 only.

Time Frame

Registration up to 24 months

Number of participants

1070

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of April 5th 2024.