Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Pembrolizumab

BCG Vaccine

Vaccines

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Adjuvants, Immunologic

Immunologic Factors

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

Laboratory Biomarker Analysis

Pharmacological Study

Joshua Meeks

The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the pembrolizumab. Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. Pembrolizumab is Food and drug Administration (FDA) approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the United States Food and Drug Administration (USFDA) for bladder cancer, hence it is considered an investigational agent for this disease.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of the study drug (pembrolizumab \[MK-3475\]) 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).

SECONDARY OBJECTIVES:

I. To describe the dose limiting toxicities (DLTs) of MK-3475 in combination with BCG in this population.

II. To assess 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.

TERTIARY OBJECTIVES:

I. To characterize the pharmacokinetics (PK) of MK-3475 in both blood and urine when administered intravesically in combination with BCG.

II. To measure humoral and cellular responses to tumor antigens on serum and urine samples by measuring the levels of cytokines (ie, interleukin \[IL\]-2, IL-6, IL-8, IL-10, IL-18, interferon gamma \[IFN-gamma\] and tumor necrosis factor alpha \[TNF-alpha\]) and peripheral blood lymphocyte phenotype throughout treatment.

III. To determine the response rate in terms of complete pathologic response in this population assessed when patient undergoes cystoscopies (weeks 17, 25, 33, 41, and 49 if applicable).

IV. To document the progression rate associated with the combination of intravesical MK-3475 and BCG in patients with high risk or BCG-refractory non-muscle-invasive bladder cancer.

V. To evaluate the relationship between tumor biomarkers programmed cell death (PD)-ligand (L)1, PD-L2, PD-1 as defined by immunohistochemistry (IHC) and adverse effects and recurrence rate.

OUTLINE: This is a dose-escalation study of pembrolizumab.

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.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.

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

A Phase 1 Dose-Escalation Study of Intravesical MK-3475 and Bacillus Calmette-Guerin (BCG) in Subjects With High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

Merck Sharp & Dohme LLC

National Cancer Institute (NCI)

Northwestern University

Joshua Meeks, MD, PhD

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 1 (1 mg/kg Pembrolizumab, 50 mg BGC)

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

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The TNM staging system is the common language in which oncology health professionals can communicate on the cancer extent for individual patients as a basis for decision making on treatment management and individual prognosis but can also be used, to inform and evaluate treatment guidelines. Tumors confined to the mucosa and invading the lamina propria are classified as stage Ta and T1, respectively, according to the Tumour, Node, Metastasis (TNM) classification system. Intra-epithelial, high-grade (HG) tumors confined to the mucosa are classified as CIS (Tis).

Cancer Stage at Baseline

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 1 (1 mg/kg Pembrolizumab, 50 mg BGC) & Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC)

Maximum Tolerated Dose (MTD)

Dose Limiting Toxicities (DLTs)

All Adverse Events Grades 1-2

All Adverse Events Grade 3

All Averse Events Grade 5

Pembrolizumab Attributed Adverse Events Only Grade 1-2

Pembrolizumab Attributed Adverse Events Only Grade 5

BGC Attributed Adverse Events Only Grade 1-2

Cohort 2 (2 mg/kg Pembrolizumab, 50 mg BGC)

Incidence of Adverse Events

Change in Cytokines in the Blood

Change in Cytokines in Urine

Expression of PD-L1

Expression of PD-1

Expression of PD-L2

Lymphocyte Profile

Plasma Concentration-time Profile

Urine Concentration-time Profile

Response Rate

Tumor Progression

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

Pre-Induction Period

Induction Period

Maintenance Phase

Survival Follow-Up

INDUCTION: Patients receive TICE BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive TICE BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

INDUCTION: Patients receive Tokyo-172 strain BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

PRIME: Patients receive Tokyo-172 strain BCG vaccine once ID. INDUCTION: Within 21 days, patients receive Tokyo-172 strain BCG solution as in Arm II. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution as in Arm II.

BCG Tokyo-172 Strain Solution

BCG Tokyo-172 Strain Vaccine

Robert Svatek

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

PRIMARY OBJECTIVES:

I. To compare whether time to high grade recurrence (TTHGR) for patients with BCG-naïve, non-muscle invasive bladder cancer (NMIBC) receiving Tokyo-172 BCG strain (Arm II) is non-inferior to patients receiving TICE BCG strain (Arm I).

II. To test whether TTHGR for patients with BCG-naïve, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation (Arm III) is superior to patients receiving intravesical Tokyo-172BCG instillation without prior intradermal BCG vaccination (Arm II).

SECONDARY OBJECTIVES:

I. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between patients receiving Tokyo-172 versus TICE BCG strain.

II. To compare TTR with AG bladder cancer between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

III. To compare progression-free survival (PFS) between patients receiving Tokyo-172 versus TICE BCG strain.

IV. To compare PFS between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

V. To compare 6-month complete response in patients with carcinoma in situ (CIS) with or without Ta or T1 cancer present at baseline receiving Tokyo-172 versus TICE BCG strain.

VI. To compare 6-month complete response in patients with CIS with or without Ta or T1 cancer present at baseline receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

TERTIARY OBJECTIVES:

I. To test the hypothesis that purified protein derivative (PPD) test conversion (positive PPD at 3 or 6 months) following BCG immunotherapy will predict time to high grade recurrence (TTHGR).

II. To test the hypothesis that urinary cytokine levels following BCG immunotherapy will predict time to high grade recurrence (TTHGR).

III. To test the hypothesis that tumor neoantigen burden and T lymphocyte infiltration are associated with BCG response.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I:

INDUCTION: Patients receive TICE BCG solution intravesically once a week for 6 weeks.

MAINTENANCE: Patients receive TICE BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

ARM II:

INDUCTION: Patients receive Tokyo-172 strain BCG solution intravesically once a week for 6 weeks.

MAINTENANCE: Patients receive Tokyo-172 strain BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

ARM III:

PRIME: Patients receive Tokyo-172 strain BCG vaccine once intradermally (ID).

INDUCTION: Within 21 days, patients receive Tokyo-172 strain BCG solution as in Arm II.

MAINTENANCE: Patients receive Tokyo-172 strain BCG solution as in Arm II.

After completion of study treatment, patients are followed up for 5 years.

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer

https://swog.org/Visitors/Download/Policies/Policy43.pdf

Rates of patients who are disease free at six months versus not

SWOG Cancer Research Network

Carcinoma in Situ

Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.

Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.

Acupuncture Therapy

Receive standard of care symptom management

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Sarah P. Psutka

This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Unfortunately, many patients experience side effects such as pelvic pain, painful urination, severe urgency, frequency, urge incontinence, need to urinate at night, and/or infectious complications. These side effects may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in which fine metallic needles are inserted into anatomical locations of the body to stimulate the peripheral and the central nervous system. Giving acupuncture before each intravesical BCG treatment may help to reduce the side effects of intravesical BCG, and help patients complete treatment. Specific outcomes of interest include acceptability to patients, effect of acupuncture on intravesical BCG-related side effects, and adverse events associated with acupuncture.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.

ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.

After completion of study, patients are followed up at 1 week.

Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer

Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer

Will be described via qualitative report.

Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.

Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.

Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.

Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report

BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.

BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test.

Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.

Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.

Will be compared via Wilcoxon rank sum test.

Fred Hutchinson Cancer Center

Associate Professor

Toxicity or AEs related to BCG administration were collected by patient survey on a weekly basis using the CTCAE v.50 assessment of Systemic Therapy Toxicity. Patients in the acupuncture arm were surveyed weekly prior to acupuncture treatments regarding side effects and potential adverse events associated with the acupuncture intervention using the CTCAE v5. There were two acupuncture-related adverse events: 1 patient reporting a Grade 1 bruise and 1 patient reporting a Grade 1 pain.

Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.

Acupuncture Therapy: Undergo acupuncture therapy

BCG Solution: Given by intravesical injection

Best Practice: Receive standard of care symptom management

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm I (Acupuncture, BCG)

Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.

Acupuncture Therapy: Undergo acupuncture therapy

BCG Solution: Given by intravesical injection

Best Practice: Receive standard of care symptom management

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm II (BCG, Standard of Care)

Age, Continuous

United States

Region of Enrollment

Smoking Status

Pathologic stage Ta: Presence of a papillary tumor that does not infiltrate the bladder wall. Tis: The existence of carcinoma in situ, which constitutes a non-invasive flat high-grade (G3) cancer. T1: Tumor penetration into the connective tissue beneath the surface lining. All other stages were excluded. Ta is the least aggressive, and Tis and T1 are the most aggressive. Please note these were not outcomes, but were inclusion criteria for patients who would be eligible to receive induction BCG and therefore would be candidates for study entry.

Tumor stage

"The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was."

Charlson Comorbidity Index

Eastern Cooperative Oncology Group (ECOG) performance status criteria is used to assess how a patient's disease is progressing and to assess how the disease affects the daily living abilities of the patient. The scores on this instrument range from 0-5 (0=fully active and 5=dead), with higher scores indicating poorer performance.

Eastern Cooperative Oncology Group (ECOG) performance status

Some patients signed the consent but couldn't start the treatment because of progression of disease, those data were not collected.

Dr. Sarah Psutka, MD, MS

Total number screened for trial eligibility

Screened for Trial Eligibility

Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled

Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)

Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)

Patient Satisfaction

Clinic Staff's Responses to Surveys

Bowel Symptoms

Fatigue

Flu-like Symptoms

Headache

Hematuria

Other

Pain

Urinary Symptoms

The number of AEs are not mutually exclusive and participants may have reported more than one AE

Number of Adverse Events

This p value relates to instillation adherence

Instillation adherence

Missed visits

BCG Instillation Adherence (Out of a Possible Planned Six Treatments)

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.

Constipation Symptoms

Diarrhea Symptoms

Bladder and Bowel Symptoms as Self Reported by Patients

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer	NCT02808143	Recurrent Bladd... Stage 0a Bladde... Stage 0is Bladd... Stage I Bladder...	BCG Solution Laboratory Biom... Pembrolizumab Pharmacological...	18 Years -	Northwestern University
S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer	NCT03091660	Stage 0 Bladder... Stage 0is Bladd... Stage I Bladder...	BCG Solution BCG Tokyo-172 S... BCG Tokyo-172 S... Laboratory Biom...	-	SWOG Cancer Research Network
Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer	NCT04496219	Bladder Urothel... Recurrent Bladd... Stage 0a Bladde... Stage 0is Bladd... Stage I Bladder... Superficial Bla...	Acupuncture The... BCG Solution Best Practice Quality-of-Life... Questionnaire A...	18 Years -	Fred Hutchinson Cancer Center
Hyperthermia and Mitomycin C, Bacillus Calmette-Guerin, or Standard Therapy as Second-Line Therapy in Treating Patients With Recurrent Bladder Cancer	NCT01094964	Bladder Cancer	BCG solution recombinant int... epirubicin hydr... mitomycin C laboratory biom... hyperthermia tr... quality-of-life...	18 Years -	National Cancer Institute (NCI)
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer	NCT02808143	Recurrent Bladd... Stage 0a Bladde... Stage 0is Bladd... Stage I Bladder...	BCG Solution Laboratory Biom... Pembrolizumab Pharmacological...	18 Years -	Northwestern University

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