Trial Outcomes & Findings for Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer (NCT NCT02808143)

Last Updated: 2024-06-26

Results Overview

Determine the MTD of the study drug (MK-3475) when administered intravesically in combination with BCG in patients with high risk or BCG-refractory non-muscle-invasive bladder cancer (up to the individual maximum tolerated dose of each drug alone). The MTD will be defined as the highest dose that causes dose limiting toxicities (DLTs) in \<2 of 6 patients graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

Up to 9 weeks

Results posted on

2024-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BCG) PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies
Pre-Induction Period STARTED	3	6
Pre-Induction Period COMPLETED	3	6
Pre-Induction Period NOT COMPLETED	0	0
Induction Period STARTED	3	6
Induction Period COMPLETED	3	6
Induction Period NOT COMPLETED	0	0
Maintenance Phase STARTED	3	6
Maintenance Phase COMPLETED	1	1
Maintenance Phase NOT COMPLETED	2	5
Survival Follow-Up STARTED	3	6
Survival Follow-Up COMPLETED	0	0
Survival Follow-Up NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BCG) PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies
Maintenance Phase Disease recurrence	1	3
Maintenance Phase Disease progression	1	2
Survival Follow-Up Still in survival Follow-up	2	3
Survival Follow-Up Disease recurrence	0	2
Survival Follow-Up Adverse Event	0	1
Survival Follow-Up Death	1	0

Baseline Characteristics

Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) n=3 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=6 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Cancer Stage at Baseline TaHG	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Cancer Stage at Baseline TaHG + CIS	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Cancer Stage at Baseline Tis	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Cancer Stage at Baseline T1	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cancer Stage at Baseline T1HG	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 9 weeks

Outcome measures

Outcome measures
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) & Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=9 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies
Maximum Tolerated Dose (MTD)	2 mg/kg Pembrolizumab	—

SECONDARY outcome

Timeframe: Up to 9 weeks

Evaluate the DLTs of MK-3475 in combination with BCG in this population. DLTs will be defined as significant adverse events occurring during the DLT observation period (2 week pre-induction phase and the 7 weeks of induction phase) that is related to either drug or the combination. DLT will be evaluated according to CTCAE v 4.03 criteria.

Outcome measures

Outcome measures
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) & Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=3 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=6 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies
Dose Limiting Toxicities (DLTs)	0 DLT Event	1 DLT Event

SECONDARY outcome

Timeframe: Up to 30 days from the last dose of study drug, up to 2.5 years

Determine the safety and tolerability of the combination of MK-3475 and BCG in subjects with high risk or BCG-refractory non-muscle-invasive bladder cancer by evaluating the number, frequency, and severity of adverse events using CTCAE v 4.03. This table provides the number of patients with their worst grade toxicity for any AEs a patient experienced and AEs that were found to have a possible, probable, or definite attribution with at least one of the study treatment agents.

Outcome measures

Outcome measures
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) & Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=3 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=6 Participants PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies
Incidence of Adverse Events All Adverse Events Grades 1-2	0 participants	3 participants
Incidence of Adverse Events All Adverse Events Grade 3	3 participants	2 participants
Incidence of Adverse Events All Averse Events Grade 5	0 participants	1 participants
Incidence of Adverse Events Pembrolizumab Attributed Adverse Events Only Grade 1-2	3 participants	4 participants
Incidence of Adverse Events Pembrolizumab Attributed Adverse Events Only Grade 5	0 participants	1 participants
Incidence of Adverse Events BGC Attributed Adverse Events Only Grade 1-2	3 participants	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At weeks -2, 0, and 17

Blood will be collected for measurement of cytokines in order to explore humoral and cellular responses to MK-3475 and BCG treatments. Cytokines will be measured using ELISA assays.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to week 49

Urine will be collected for measurement of cytokines in order to explore humoral and cellular responses to MK-3475 and BCG treatments. Cytokines will be measured using ELISA assays.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and then up to 49 weeks

Expression of tumor biomarker PD-L1 as defined by immunohistochemistry (IHC) will be assessed and results will be correlated with adverse effects and recurrence rate. This evaluation will be performed on archived tissue samples obtained at baseline and on fresh tissue from any subsequent biopsies.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and then up to 49 weeks

Expression of tumor biomarker PD-1 as defined by immunohistochemistry (IHC) will be assessed and results will be correlated with adverse effects and recurrence rate. This evaluation will be performed on archived tissue samples obtained at baseline and on fresh tissue from any subsequent biopsies.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and then up to 49 weeks

Expression of tumor biomarker PD-L2 and immune cell infiltration as defined by immunohistochemistry (IHC) will be assessed and results will be correlated with adverse effects and recurrence rate. This evaluation will be performed on archived tissue samples obtained at baseline and on fresh tissue from any subsequent biopsies.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At weeks -2, 0, and 17

Peripheral blood will be taken for evaluation of a lymphocyte profile which will be analyzed using automated flow cytometric techniques and will measure humoral and cellular response to tumor antigens.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week -2: At minute 0, then 15, 30, and 60 minutes post-dosing

Blood serum concentrations of MK-3475 will be evaluated during pre-induction (week -2) at baseline (0 minutes) and at 15, 30, and 60 minutes post-dosing for determination of plasma PK parameters.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4: At minute 0, then 15, 30, and 60 minutes post-dosing

Blood serum concentrations of MK-3475 will be evaluated during induction (week 4) at baseline (0 minutes) and at 15, 30, and 60 minutes post-dosing for determination of plasma PK parameters.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week -2: At 30 minutes prior to dosing and 2 hours after dosing

Urine concentrations of MK-3475 will be evaluated during induction (week -2) at 30 minutes prior to dosing and 2 hours post-dosing for determination of urine concentration-time profile.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4: At 30 minutes prior to dosing and 2 hours after dosing

Urine concentrations of MK-3475 will be evaluated during induction (week 4) at 30 minutes prior to dosing and 2 hours post-dosing for determination of urine concentration-time profile.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and up to 49 weeks

Determine the response rate in terms of complete pathologic response in this population will be assessed when the patient undergoes cystoscopies. Patients will be examined via bladder cystoscopy and may undergo biopsy for pathological confirmation if needed. Responses will be categorized as yes or no for bladder recurrence.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 49 weeks

The progression rate of the tumor will be defined as positive transurethral resection and/or biopsy.

Outcome measures

Outcome data not reported

Adverse Events

Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Cohort 1 (1 mg/kg Pembrolizumab, 50 mg BGC) n=3 participants at risk PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies	Phase I: Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC) n=6 participants at risk PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses. BCG Solution: Given intravesically Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given intravesically Pharmacological Study: Correlative studies
Cardiac disorders Myocardial Infarctrion	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Renal and urinary disorders Hematuria	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Cardiac disorders Sinus Bradycardia	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Immune system disorders Autoimmune Disorder	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Number of events 2 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Pelvic Infection	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Number of events 1 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Nervous system disorders Tremor	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Number of events 1 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.

Other adverse events

Additional Information

Joshua Meeks, MD, PhD

Northwestern University Feinberg School of Medicine

Phone: 312-363-8959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place