Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

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

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Avelumab

BCG Vaccine

Antineoplastic Agents, Immunological

Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.

Induction phase:

* once weekly for weeks 1-6,
* once every 2 weeks at week 8, 10, and 12

Maintenance phase:

* Once every week for weeks 1-3
* Once every 2 weeks starting at week 5, until the next BCG treatment

Induction phase (cycle 1):

• Once weekly for weeks 1-6

Maintenance phase (Month 3, 6, and 12):

• Once weekly for 3 weeks

Kelly Stratton, MD

The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recurrent bladder cancer.

There will be exams, tests and procedures to see if the patient is eligible for the study. Some are part of regular cancer care and others are part of the study. Subjects will also need to complete a research questionnaire at certain points in the study.

Subjects will receive treatment of avelumab and intravesical BCG until unacceptable toxicity or tumor progression.

Study participation is up to three years.

Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer

Phase Ib Study of Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (ABC Trial)

Proportion of patients receiving complete induction course, defined as freedom from DLT preventing completion of at least 5 of 6 treatments of BCG + avelumab

completion of at least 2 of 3 treatments within each 5 week period

based on negative cystoscopy and urine cytology. A negative biopsy at 6 months will provide evidence of complete response.

defined as percent of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy.

defined as proportion of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy

defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause

EMD Serono

University of Oklahoma

Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.

Avelumab: Induction phase:

* once weekly for weeks 1-6,
* once every 2 weeks at week 8, 10, and 12

Maintenance phase:

* Once every week for weeks 1-3
* Once every 2 weeks starting at week 5, until the next BCG treatment

BCG: Induction phase (cycle 1):

• Once weekly for weeks 1-6

Maintenance phase (Month 3, 6, and 12):

• Once weekly for 3 weeks

BCG + Avelumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Associate Professor

Proportion of Patients Receiving Complete Induction Course

Patients who remained on study for induction course

Percent of Patients With Complete Response

Proportion of Patients With Complete Response

Patients who experienced complete response

Percent of Patients With Recurrence Free Survival

Proportion of Patients With Recurrence Free Survival

Patients who experienced progression or death or who stayed on study for at least 6 months

Proportion of Patients With Progression-free Survival

Patients who experienced progression or death or who remained at study at least 12 months

Overall Study

Nivolumab

Linrodostat

Immune Checkpoint Inhibitors

Enzyme Inhibitors

BMS-986205

Bristol-Myers Squibb

A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:

* Results in death
* Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
* Requires inpatient hospitalization or causes prolongation of existing hospitalization.

SAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs leading to discontinuation are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity IMAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment.

ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal.

On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment.

TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal

On-study laboratory parameters include hematology, chemistry, liver function, and renal function. On-study laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment. On-study lab parameters are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug.

An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:

* Results in death
* Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
* Requires inpatient hospitalization or causes prolongation of existing hospitalization.

An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug.

An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.

Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).

Arm A: Nivolumab

Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.

Arm B: Nivolumab Plus Intravesical BCG

Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).

Arm C: Nivolumab Plus BMS-986205

Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.

Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG

Total

White

Asian

Race/Ethnicity, Customized

As of early April 2021, Study CA2099UT enrollment was significantly behind the projected target enrollment, (number of participants enrolled 142; target enrollment 480). Since the study would be unable to meet the scientific objectives within a projected timeline, a decision was made in May 2021 to close the study.

Bristol-Myers Squibb Study Director

All randomized participants who received at least one dose of any study medication.

Number of Participants With Adverse Events (AEs)

Number of Participants With Serious Adverse Events (SAEs)

Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment

Number of Participants Immune-Mediated Adverse Events (IMAEs)

Number of Participants Who Died

ALT OR AST > 3XULN

ALT OR AST> 5XULN

ALT OR AST> 10XULN

ALT OR AST > 20XULN

TOTAL BILIRUBIN > 2XULN

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS

ALP>1.5XULN

All randomized participants who received at least one dose of any study medication and had at least one on-treatment liver laboratory measurement.

Number of Participants With Specific Liver Laboratory Abnormalities

TSH > ULN

TSH > ULN WITH TSH <= ULN AT BASELINE

TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN

TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN

TSH > ULN WITH FT3/FT4 TEST MISSING

TSH < LLN

TSH <LLN WITH TSH >= LLN AT BASELINE

TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN

TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN

TSH < LLN WITH FT3/FT4 TEST MISSING

All randomized participants who received at least one dose of any study medication and had at least one on-treatment thyroid laboratory measurement.

Number of Participants With Specific Thyroid Laboratory Abnormalities

Hemoglobin

Platelet Count

Leukocytes, Local Lab

Lymphocytes (Absolute)

Lymphocytes (Absolute), Local Lab

Absolute Neutrophil Count

Alkaline Phosphatase (ALP), Local Lab

Aspartate Aminotransferase (AST), Local Lab

Alanine Aminotransferase (ALT), Local Lab

Bilirubin Total, Local Lab

Creatinine, Local Lab

Hypernatremia

Hyponatremia

Hyperkalemia

Hypokalemia

Hypercalcemia

Hypocalcemia

Hypermagnesemia

Hypomagnesemia

Hyperglycemia

Hypoglycemia

All randomized participants who received at least one dose of any study medication and had at least one on-study select laboratory measurement.

Number of Participants With Changes From Baseline Laboratory Values

Nivolumab ADA Positive

Nivolumab ADA Negative

All randomized participants who received at least one dose of any study medication and had evaluable ADA status.

Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status

Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status

Antibodies

Antibodies, Monoclonal

Gemcitabine

Cisplatin

Immunomodulating Agents

Atezolizumab

Immunoglobulins

Adjuvants, Immunologic

Vaccines

Antimetabolites

Immunologic Factors

The Intravesical recombinant BCG (Bacillus Calmette-Guérin - VPM1002BC) is used as an immuno-stimulating agent. The patient will receive 3 weekly BCG instillations as induction treatment.

4 cycles of atezolizumab, a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1 inhibitor) will be administered in combination with the standard neoadjuvant chemotherapy cisplatin/gemcitabine.

After surgery atezolizumab will be administered in the adjuvant setting for 13 cycles.

1 dose of VPM1002BC, live, 1-19.2 x 108 colony forming units (CFU) on day 1, 8 (+/- 1 day) and 15 (+/- 1 day)

Recombinant intravesical BCG (Bacillus Calmette-Guérin VPM1002BC)

Neoadjuvant immunotherapy with atezolizumab, 4 cycles 1200 mg fixed dose iv infusion on d1 q3w starting 4-16 weeks after date of surgery

Neoadjuvant chemotherapy with cisplatin: 4 cycles 70mg/m2 iv infusion on d1 q3w (starting on d22)

Neoadjuvant chemotherapy with gemcitabine: 4 cycles 1000 mg/m2 iv infusion on d1 and d8 q3w (starting on d22)

Sabrina Chiquet

Andreas Erdmann, MD

Frank Stenner, Prof

Ursula Vogl, MD

Martin Spahn, Prof

Richard Cathomas, MD

Petros Tsantoulis, MD

Christian Fankhauser, MD

Stefanie Aeppli, MD

Anja Lorch, Prof

Ulf Petrausch, MD

Current treatment of localized muscle-invasive bladder cancer is still associated with high relapse and death rate as well as the need for complete bladder resection or irradiation.

The primary objective of this trial is to increase the rate of pathologic complete remission (pCR) at the time of radical cystectomy by the combination of local bladder instillation with Bacillus Calmette Guérin (BCG) in combination with systemic immunotherapy with atezolizumab and standard chemotherapy with cisplatin/gemcitabine.

The trial tests the hypothesis whether BCG can enhance systemic and local immune response and thereby increase pCR rate and consequently also event-free survival. Improving pCR rate would be a next step to the ultimate goal of omitting radical surgery or extensive local radiotherapy to the bladder for these patients.

Current treatment of localized muscle-invasive bladder cancer is still associated with high relapse and death rate as well as the need for complete bladder resection or irradiation.

In recent years, immunotherapy using PD-1 or PD-L1 immune checkpoint inhibitors (ICI) proved successful for patients with metastatic bladder cancer. The checkpoint inhibitors atezolizumab (anti PD-L1), pembrolizumab (anti PD-1) and nivolumab (anti PD-1) now represent the standard of care in the second line setting of metastatic bladder cancer and are all approved by Swissmedic for this indication.

First results, in 2018, have been presented and published using immune checkpoint inhibitors as neoadjuvant treatment for localized muscle-invasive bladder cancer. SAKK has also performed a single arm phase II trial using neoadjuvant chemo-immunotherapy with cisplatin/gemcitabine in combination with the PD-L1 inhibitor durvalumab (SAKK 06/17). A preplanned interim analysis of the first 30 operated patients revealed a pCR rate of 30%. In this study, residual non-muscle invasive bladder cancer (NMIBC) was found in approximately 15% of cases. While these results are encouraging, the improvement of pCR rate compared to cisplatin-based chemotherapy alone is small and further improvement is needed.

BCG induces an intense local inflammatory response that mediates tumor immunity. Several steps are involved in mounting the inflammatory response including attachment to the urothelium with uptake by antigen presenting cells (APC) and putative internalization into urothelial cells followed by a boost of the innate immune response and induction of adaptive responses. Based on these findings, intravesical BCG appears to be a very interesting agent to enhance the immune response and act as an adjuvant agent to increase anti-tumor response with immune checkpoint inhibition using monoclonal antibodies such as atezolizumab. The combination of intravesical BCG and systemic immune checkpoint inhibition is being studied for patients with non-muscle invasive bladder cancer in several ongoing phase III trials.

the investigators therefore propose to add an induction cycle of intravesical recombinant BCG (VPM1002BC) (total of 3 weeks) to the backbone of neoadjuvant chemo-immunotherapy with cisplatin/gemcitabine and atezolizumab. The trial tests the hypothesis if recombinant BCG can enhance systemic and local immune response and thereby increase pCR rate and consequently also event-free survival. Improving pCR rate would be a next step to the ultimate goal of omitting radical surgery or extensive local radiotherapy to the bladder for these patients.

Prospective single-arm open-label multicenter phase II trial

Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC

Intravesical Recombinant BCG (Bacillus Calmette Guérin) Followed by Perioperative Chemo-immunotherapy for Patients With Muscle-invasive Bladder Cancer (MIBC). A Multicenter, Single-arm Phase II Trial

The primary endpoint of the trial is pCR after neoadjuvant treatment defined as ypT0ypN0 and no evidence of non-muscle invasive bladder cancer (low grade, high grade or CIS).

The primary analysis will be based on the results from central pathology review.

EFS is defined as the time from treatment start until one of the following events, whichever comes first:

* Progression during neoadjuvant treatment leading to inoperability
* Recurrence or progression (in case of disease persistence) of locoregional disease after surgery
* Appearance of metastases at any localization
* Death Patients without event at the time of analysis and patients starting a subsequent treatment in the absence of an event will be censored at the date of the last available assessment showing no event before the start of the subsequent treatment, if any.

This endpoint will be calculated for patients in the FAS.

RFS after R0 resection is defined as the time from surgery until one of the following events, whichever comes first:

* Recurrence of locoregional disease
* Appearance of metastases at any localization
* Death Patients without event at the time of analysis and patients starting a subsequent treatment in the absence of an event will be censored at the date of the last available assessment showing no event before the start of the subsequent treatment, if any.

This endpoint will only be calculated for patients in the R0 resection set.

OS is defined as the time from treatment start until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

This endpoint will be calculated for patients in the FAS.

The quality of resection will be assessed in the following way:

• Complete resection (R0) defined as free resection margins proved microscopically This endpoint will only be calculated for patients in the resected patients set.

The quality of resection will be assessed in the following way:

• Completeness of the lymphadenectomy and surgery using the photo documentation and histopathology This endpoint will only be calculated for patients in the resected patients set.

The quality of resection will be assessed in the following way:

• Postoperative complications will be assessed using the Clavien-Dindo classification.

This endpoint will only be calculated for patients in the resected patients set.

PaR rate is defined as pathological downstaging to ≤ ypT1N0M0. The proportion of patients with PaR will be calculated for patients in the resected patients set.

This endpoint will only be calculated for patients in the resected patients set.

Pattern of recurrence is defined as location of first tumor recurrence. Patterns can be locoregional or distant or any combination of these patterns.

Patients with secondary malignancies or patients with no recurrence will not be taken into consideration for this endpoint.

The following feasibility criteria will be assessed:

* Completion of 3 instillations of intravesical VPM1002BC
* Completion of 4 cycles of neoadjuvant chemotherapy
* Completion of 4 cycles of neoadjuvant atezolizumab treatment
* Timely admission to and completion of planned surgery
* Timely initiation and completion of 13 cycles of adjuvant atezolizumab treatment

All AEs will be assessed according to NCI CTCAE v5.0. This endpoint will be calculated for patients in the safety set.

Swiss Group for Clinical Cancer Research

Symptoms and General Pathology

Lower Urinary Tract Symptoms

Urological Manifestations

Pharmaceutical Solutions

Intravesical instillation of 50 ml sterile Baobab natural oil. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter.

Intravesical baobab oil

Savino M Di Stasi, MD, PhD

Baobab oil is often used in traditional medicine as antipyretic, antioxidant, anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in a short time improving tone and elasticity. We want to evaluate the effects of intravesical Baobab oil in patients with BCG-induced lower urinary tract symptoms.

After complete transurethral resection of primary high risk non-muscle invasive bladder tumors (stage pTa, pT1, carcinoma in situ and high grade urothelial carcinoma), patients on induction course of intravesical BCG with lower urinary tract symptoms unresponsive to standard therapies are enrolled. The patients supply written informed consent to a document describing the investigational nature of the protocol.

Induction treatment consists of an initial 6 intravesical BCG treatments at weekly interval commencing approximately 3 weeks after transurethral resection procedures. The BCG instillation consisted of 81 mg wet weight (10•2±9•0 x 108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG is suspended in 50 mL bacteriostatic-free solution of 0•9% sodium chloride. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 120 min, followed by emptying of the bladder and removal of the catheter.

During BCG treatment patients with persistent lower urinary tract symptoms unresponsive to standard therapies (anticholinergics, alpha-blockers, antibiotics, analgesics and anti-inflammatory drugs) are treated with an intravesical instillation of 50 ml sterile Baobab natural oil (Baotrophic, Physion Srl, Mirandola, Italy). After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter.

Lower urinary tract symptoms are self-recorded by the patients before and after each baobab oil instillation and classified by the investigator according to a classification grid considering account duration and intensity. The classification of symptoms is class 0= none, class I = mild, class II = moderate, and class III = severe, according to severity. Local adverse events are cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. The outcome measures are analyzed before and every day for one week after treatment. All patients are assessed for safety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer	NCT03892642	Bladder Cancer	Avelumab BCG	18 Years -	University of Oklahoma
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder	NCT03519256	Urinary Bladder...	Nivolumab BCG BMS-986205	18 Years -	Bristol-Myers Squibb
Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC	NCT04630730	Bladder Cancer	Recombinant int... Atezolizumab Cisplatin Gemcitabine	18 Years -	Swiss Group for Clinical Cancer Research
Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms	NCT01939756	Superficial Bla... Lower Urinary T...	Intravesical ba...	18 Years - 90 Years	University of Rome Tor Vergata
Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC	NCT04630730	Bladder Cancer	Recombinant int... Atezolizumab Cisplatin Gemcitabine	18 Years -	Swiss Group for Clinical Cancer Research
Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer	NCT03892642	Bladder Cancer	Avelumab BCG	18 Years -	University of Oklahoma

Spots Global Cancer Trial Database for intravesical bcg