Trial Outcomes & Findings for Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer (NCT NCT02281383)

Last Updated: 2023-02-08

Results Overview

(by cystoscopy and cytology) Participants who have a response are those who have no evidence of disease in their bladder by both urine cytology and cystoscopy. Participants whose disease remains at the same stage or is downstaged without complete resolution are considered nonresponders and will be documented as having recurred. Participants with worsening tumor, defined as the upstaging from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

6 months

Results posted on

2023-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Bacillus Calmette-Guérin (BCG) Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
Overall Study STARTED	80
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Bacillus Calmette-Guérin (BCG) Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
Overall Study Progressive Disease	1
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	2
Overall Study Death	1
Overall Study Adverse Event	2

Baseline Characteristics

Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bacillus Calmette-Guérin (BCG) n=80 Participants Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Bacillus Calmette-Guérin (BCG) n=80 Participants Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
Response Rate Complete Response	62 Participants
Response Rate Stable Response	18 Participants

SECONDARY outcome

Timeframe: 2 years

Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.

Outcome measures

Outcome measures
Measure	Bacillus Calmette-Guérin (BCG) n=62 Participants Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
Percentage of Participants With Recurrence-free Survival After Complete Response	85 percentage of participants Interval 77.0 to 95.0

Adverse Events

Bacillus Calmette-Guérin (BCG)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Bacillus Calmette-Guérin (BCG) n=80 participants at risk Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
Renal and urinary disorders Hematuria	1.2% 1/80 • 2 years
Infections and infestations Infections and infestations - Other, specify	1.2% 1/80 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 1/80 • 2 years
Infections and infestations Sepsis	1.2% 1/80 • 2 years

Other adverse events

Other adverse events
Measure	Bacillus Calmette-Guérin (BCG) n=80 participants at risk Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses. Bacillus Calmette-Guérin (BCG)
General disorders Fatigue	10.0% 8/80 • 2 years
Renal and urinary disorders Cystitis noninfective	5.0% 4/80 • 2 years

Additional Information

Dr. Harry Herr, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place