Bladder Cancer

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Randomized Phase II Study of Antibiotic Prophylaxis With Fosfomycin vs Amikacin in Transurethral Resection of Bladder


Condition: Urinary Tract Infections, Bladder Cancer, Urologic Surgical Procedures

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04209192

Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients 18 years old of age
  • Patients with a programmed TURB
  • Absence of urinary tract infection (negative urine culture and no clinical manifestations for urinary tract infection)

Exclusion Criteria:

  • Patients with asymptomatic bacteriuria
  • Patients with positive urine culture before procedure
  • Patients with urinary catheterization

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Transurethral Modified En Bloc Resection For Large Bladder Tumours.


Condition: Bladder Cancer, Bladder Neoplasm, Bladder Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04081246

Sponsor: Chinese University of Hong Kong

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  • Age 18 to 80 years old with informed consent
  • Bladder tumours with maximal dimension of ≥ 3cm

Exclusion Criteria:

  • Bladder tumour detected during intravesical Bacillus Calmette-Guerin therapy (These patients warrant more aggressive treatment, i.e. radical cystectomy)
  • Estimated glomerular filtration rate of <60mL/min.
  • Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
  • Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
  • History of bleeding disorder or use of anti-coagulant
  • Presence of other active malignancy
  • ECOG performance status ≥ 2 (Ambulatory and capable of all self care but unable to carry our any work activities. Confined to bed or chair less than 50% of waking hours)
  • Pregnancy
  • Presence of metallic foreign body or implant which is not MRI compatible
  • Known history of claustrophobia

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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


Condition: Non-muscle Invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04165317

Sponsor: Pfizer

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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.

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Intravesical Instillation Therapy With Bacillus Calmette-Guérin (BCG) and Sequential BCG and Electromotive Mitomycin-C (EMDA-MCC) in Patients With High-risk Non-muscle-invasive Bladder Carcinoma


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03664869

Sponsor: Turku University Hospital

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
  • Carcinoma in situ with or without a papillary tumour(s)
  • Ta tumour(s) of high-grade
  • Any T1 tumour(s)
  • Written informed consent is required from every eligible patient
  • Second resection performed in case of T1 tumour
  • Adequate physical and mental condition to participate in the study (as judged by treating physician

Exclusion Criteria:

  • Ta low grade tumour(s)
  • Muscle invasive (pT≥2) tumors
  • Urothelial cancer involving the prostatic urethra or upper urinary tract
  • Non-urothelial bladder cancer.
  • Prior BCG failure (If the patient has previously been successfully treated with BCG, and duration from the last instillation is >12 months, participation may be considered, if bladder preserving is chosen)
  • Prior or concurrent immunotherapy
  • Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
  • Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
  • Known allergy to MMC or BCG
  • Age < 18 years
  • Pregnancy or lactating patient
  • Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
  • Cardiac pacemaker
  • Expected survival time less than one year
  • Expected poor compliance

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Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study


Condition: Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03973307

Sponsor: East and North Hertfordshire NHS Trust

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients aged ≥ 18 years of age
  • Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy

Exclusion Criteria:

  • Patients aged < 18 years of age
  • Patients who are currently undergoing radiation therapy.
  • Proposed subject has no bladder (due to surgical removal).
  • No cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results)
  • Patients unable or unwilling to provide consent
  • Patients currently on investigational drug trials
  • Patients with Catheter in Situ

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Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer


Condition: Superficial Bladder Cancer, Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03379909

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age > 18 years.
  • Patients with primary or recurrent multiple histologically confirmed Ta or T1 (non-muscle invasive), G1 or G2 (low grade) urothelial carcinoma of the bladder with no evidence of carcinoma in situ.
  • Patients must have at least 2 lesions but no more than 10.
  • The resected lesions must contain detrusor muscle to confirm a Ta/T1 disease.
  • All visible lesions must be completely removed by transurethral resection at entry to the study, except for an untouched marker lesion measuring 0.5-1.0 cm in its greatest dimension.
  • Bimanual examination immediately following transurethral resection under anaesthesia should be carried out and no mass should be felt.
  • Adequate renal function (creatinine <150 μmol/L and/or an eGFR >60 ml/L).
  • Adequate liver function (bilirubin <1.5 times upper limit of normal, ALAT or ASAT <2.5 the upper limit of normal).
  • Eligible patients must be fully informed of the investigational nature of the study and written signed informed consent must be obtained prior to any study specific investigations.
  • Mentally, physically, and geographically able to undergo treatment and follow up.

Exclusion Criteria:

  • Patients having muscle-invasive disease (stage T2 or greater) or CIS.
  • Patients with grade 3 (high-grade) tumours.
  • Patients with diabetes mellitus receiving metformin or having received metformin in the past 6 months.
  • Patients who have received intravesical treatment (chemotherapy or immunotherapy) within the last 3 months.
  • Patients that are currently receiving other anti-cancer therapy.
  • Patients with existing urinary tract infection or recurrent severe bacterial cystitis.
  • Patients that need to be treated with a transurethral catheter.
  • Patients with urogenital tumours with histology other than urothelial carcinoma (i.e. squamous cell or adenocarcinoma) or with urothelial carcinoma involving the upper tract or the prostatic urethra.
  • Patients with a history of other primary malignancy (other than squamous or basal cell skin cancers or cone biopsied CIS of the uterine cervix or prostate carcinoma treated curatively with normal PSA values at inclusion) in the last five years.
  • Patients with active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems that, in the opinion of the investigator, would predispose to the development of complications from the administration of metformin.
  • Patients who are using loop diuretics, cimetidine, ranitidine, cetirizine, trimethoprim, vandetanib, kinidine and/or HIV medication, for which no reasonable alternative is available.
  • Women who are pregnant or lactating. Individuals of reproductive potential may not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partner.
  • Patients with ECOG-WHO performance status of 3 or 4.
  • Patients with a known history of alcohol abuse.
  • Patients with a known hypersensitivity to metformin.
  • Patients who in the investigator's opinion, cannot comply with provisions of the protocol or do not understand the nature of the study.

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A Phase 1b-2 Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study


Condition: Urinary Bladder Cancer, Invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03844256

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Be willing and able to provide written informed consent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Wish to preserve their bladder function or be ineligible for cystectomy.
  • Must have undergone transurethral biopsy of the bladder tumor, within 35 days of planned treatment commencement. The patient should have a histologically-confirmed diagnosis of muscle-invasive T2-T4a, N0-1M0 urothelial cell carcinoma of the bladder.
  • Must have undergone maximal transurethral resection of the bladder tumour, to an extent that is judged as safe by the urologist performing the resection, within 35 days of planned treatment commencement.
  • Subjects with tumors of mixed urothelial/non-urothelial cell histology are allowed, but urothelial cell carcinoma must be the predominant histology (>50%). Subjects with predominant or exclusively non-urothelial cell histology are not allowed.
  • Have planned for chemoradiotherapy as definitive treatment.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale
  • Have a bladder function that is accessible for cystoscopical follow up.
  • Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.
  • Female participants of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female participants of childbearing potential should be willing to one highly effective method of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 month after the last dose of study medication Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male participants should agree to use condoms starting with the first dose of study therapy through 7 month after the last dose of study therapy.
  • Willing to consent to the use of their collected tumor specimen, blood and urine as detailed in the protocol for future scientific research including but not limited to DNA, RNA and protein based biomarker detection.

Exclusion Criteria:

  • Has DPD deficiency.
  • Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) urothelial cell carcinoma of the urothelium. Patients who have involvement of the prostatic urethra with urothelial cell cancer may be included if the location can be safely incorporated in the radiation field.
  • Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative chemoradiotherapy.
  • Evidence of distant metastatic disease on a CT or FDG PET/CT chest/abdomen/pelvis performed within 28 days prior to study entry. Up to 3 metastatic lymphnodes in the pelvis (below the common iliac arteries) are allowed, if these can be incorporated in the radiotherapy field.
  • Prior pelvic lymph-adenectomy
  • Prior pelvic radiotherapy
  • Has had prior intravenous chemotherapy, targeted small molecule therapy, or radiation therapy for treatment of bladder cancer. Prior intravesical use of BCG and MMC is permissible.
  • Unsuitable for concurrent MMC / capecitabine based ChRT based on pre-existing medical conditions.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy over 10mg daily prednisone (or equivalent) or any other form of immunosuppressive therapy within 14 days prior to registering the patient. Patients with adrenal insufficiency receiving replacement dose steroids are allowed on the trial.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to nivolumab and/or ipilimumab or any of its excipients.
  • Prior or concurrent known additional malignancy of any site unless disease free for 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, Stage T1a well differentiated prostatic carcinoma in men (Gleason = 3+3, PSA <5)
  • Has any history of active autoimmune disease, Stevens-Johnson syndrome or Guillain-Barre. Exceptions to this are: 1. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone 2. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has an Human Immunodeficiency Virus (HIV) infection with a PCR detectable viral load.
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

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Basal Tumours in Bladder Cancer, Response to chemoTherapy


Condition: Bladder Cancer, Chemotherapy Effect

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04089748

Sponsor: University Hospital, Rouen

Phase:

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  • of Patients enrolled in VESPER study: Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort and :
  • having signed an informed consent form for the participation to the collection or
  • dead/lost to follow-up without prior opposition expressed against research program,
  • genetic analysis will only be carried out for patients who have signed the genetic consent form. Inclusion Criteria of Patients from St Louis cohort not enrolled in VESPER study: Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort and :
  • having received an informed form for the participation to the collection and not having expressed opposition against research program within 1 month or
  • dead/lost to follow-up without prior opposition expressed against research program,

Exclusion Criteria:

  1. -Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project. OR -Patients from St Louis not enrolled in VESPER study:Tumors from patient having expressed opposition against research program after 1 month for the participation to the collection.

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A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy


Condition: Bladder Cancer, Urothelial Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04018053

Sponsor: Dana-Farber Cancer Institute

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed urothelial carcinoma of the bladder.
  • Participants must have cT2-T4N0 disease at the time of the study, as defined by conventional CT or MRI imaging. Patients must have no definite evidence of locoregional or distant metastatic disease at the time of study eligibility, as defined by conventional imaging.
  • Radical cystectomy must be planned for the patient after the planned 18F-fluciclovine-PET/CT.
  • Patients may or may not have had prior neoadjuvant therapy prior to this study.
  • Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and the majority of bladder cancer occur in the adult population [42], children are excluded from this study but will be eligible for future pediatric trials.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Ability and willingness to comply with the study procedures.
  • The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Participants with other known malignancies that has required treatment in the past 3 years.
  • Pregnant women are excluded from this study because 18F-fluciclovine is a radiopharmaceutical with the potential for teratogenic effects. Because of the radiation exposure to a nursing infant from 18F-fluciclovine, women who are breastfeeding are also excluded from this study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Contraindications for PET/CT including:
  • Severe claustrophobia
  • Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study

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Phase I Safety and Tolerability of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer (NMIBC)


Condition: Urothelial Carcinoma of the Urinary Bladder

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03854721

Sponsor: Vaxiion Therapeutics

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Signed, informed consent
  2. Age 18 or more years
  3. Pathologically confirmed low-grade Ta urothelial carcinoma (UC) of the urinary bladder
  4. NMIBC with one solitary measurable tumor at the start of study, measuring ≥ 5 mm and ≤ 15 mm in greatest diameter (up to 4 additional low-grade Ta lesions, each measuring no more than 15 mm may be removed at screening provided a single lesion remains)
  5. Treatment-naïve or failed one previous regimen of intravesical therapy (BCG or chemotherapy)
  6. If recurrent disease, then more than 6 months from prior resection, more than 3 months from completion of last intravesical therapy with BCG, and more than 6 weeks from completion of last therapeutic intravesical therapy with chemotherapy
  7. If previously treated, recovered from prior treatment-related toxicity to ≤ Grade 1
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 116
  9. Absolute neutrophil count (ANC) ≥ 1,500/mm3
  10. Platelet count ≥ 100,000/mm3
  11. Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤ 3 x ULN in subjects with Gilberts disease
  12. Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min
  13. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x ULN
  14. Willingness to participate in collection of pharmacokinetic samples
  15. Women of childbearing potential must have a negative serum pregnancy test.
  16. All subjects of childbearing potential must be willing to use effective contraception while on treatment and for 3 months after the last dose of VAX014

Exclusion Criteria:

  1. Additional papillary disease at screening (in addition to the solitary low-grade Ta lesion detailed in the inclusion criteria) that
  2. Consist of 6 or more lesions
  3. Consists of any lesion with a maximal diameter of greater than 15 mm
  4. Confirmed or suspected perforated bladder
  5. History of difficult catheterization that in the opinion of the investigator will prevent administration of VAX014
  6. Presence or history of any high-grade urothelial cancer (including CIS) or high-grade urine cytology
  7. Intravesical chemo-or biological therapy within 6 months of first administration of VAX014
  8. UC of the ureters or urethra
  9. History of interstitial cystitis
  10. History of radiation to the pelvis
  11. History of vesicoureteral reflux or an indwelling urinary stent
  12. Other known active cancer(s) likely to require treatment or interfere with study objectives over the next two (2) years
  13. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  14. Known HIV, Hepatitis B, or Hepatitis C infection
  15. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months)
  16. Major surgery other than diagnostic surgery within 4 weeks of first administration of VAX014
  17. Pregnant or currently breast-feeding
  18. Psychiatric illness/social situations that would interfere with compliance with study requirements
  19. Presence of any sessile appearing tumor suspected of being invasive or high-grade

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A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes


Condition: Bladder Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03757949

Sponsor: Southwest Oncology Group

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients must have a tissue diagnosis of primary cell carcinoma of the bladder by transurethral resection of bladder tumor (TURBT) or partial cystectomy; patients may not have any evidence of unresectable disease or metastatic disease as assessed by exam under anesthesia or imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron-emission tomography [PET])
  • There must be plans for the cystectomy to be performed within 28 calendar days after registration
  • Surgery must be planned to be performed under pre-approved, study-specific surgical guidelines
  • Patients must have completed any neoadjuvant chemotherapy or immunotherapy (intravesical or systemic) >= 14 calendar days prior to registration and any toxicities resolved to at least grade 2
  • Patients may have a history of radiation therapy; radiation therapy must have been completed >= 180 days prior to registration
  • Patients may have a history of prior partial cystectomy; prior partial cystectomy must have been completed at least 180 days prior to registration
  • Patients with planned adjuvant chemotherapy within 90 days after radical cystectomy will not be eligible
  • Patients must be able to swallow liquid and have no refractory nausea, vomiting, malabsorption, or significant small bowel resection that would preclude adequate absorption; patients on tube feeding are not eligible
  • Patients must have their baseline nutrition status assessed using the Scored Patient-Generated Subjective Global Assessment (PG-SGA) by a clinician or licensed healthcare practitioner (trained physician, nurse, or dietician) within 14 days prior to registration and must not have a global category rating of stage C (severely malnourished)
  • Patients must not have galactosemia
  • Patients must not have known active viral infections such as human immunodeficiency virus (HIV) or hepatitis, as these chronic viral infections may cause cachexia and immunodeficiency and thus alter the biology regarding the study endpoints
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years; prostate cancer found at cystectomy would not be considered a prior malignancy
  • Patients must not be pregnant or nursing as the conditions preclude candidacy for radical cystectomy
  • Patients must consent and be willing to have specimens collected and submitted
  • Patients must be offered the opportunity to participate in additional specimen banking
  • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Patients must consent and provide their telephone contact information for four 24-hour dietary recall phone interviews to be conducted by staff at the Exercise, Diet, Genitourinary, & Endocrinology Laboratory (EDGE) Research Laboratory
  • Patients must be able to understand and speak English and/or Spanish because the dietary recall phone interviews will only be conducted in English or Spanish

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A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)


Condition: Urinary Bladder Cancer, Muscle-invasive

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03924856

Sponsor: Merck Sharp & Dohme LLC

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology
  • Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
  • Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate organ function
  • Male and female participants are eligible to participate if they agree to the contraception use as per study protocol

Exclusion Criteria:

  • Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
  • Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC
  • prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
  • Has ≥N2 disease or metastatic disease (M1) as identified by imaging
  • Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
  • Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
  • Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection
  • Has a known psychiatric or substance abuse disorder
  • Has had an allogenic tissue/solid organ transplant

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Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer - A Single-center, Single-arm and Stage II Clinical Study


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04060459

Sponsor: Third Military Medical University

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Patients must have histologically confirmed resectable(stage T2,T3 and T4a) urothelial carcinoma following 2017 V8 AJCC,including renal pelvic carcinoma,ureteral carcinoma,bladder carcinoma and urethral carcinoma.
  3. There was at least one measurable tumor lesion following RECIST 1.
  4. Treatment naïve.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-
  6. Left ventricular ejection fraction≥50%.
  7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,platelets (PLT) ≥ 100 × 109/L,hemoglobin (Hb) ≥ 90 g/L,leucocyte ≥ 3.0 × 109/L.
  8. Total bilirubin (TBIL) ≤ 1.5 ×institutional upper limit of normal (ULN), Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]≤ 2.5 ×ULN ,Creatinine (CRE) ≤ 1.5 ×ULN.
  9. Signed informed content obtained prior to treatment.

Exclusion Criteria:

  1. Patients who are pregnant or may be pregnant or nursing.
  2. Patients with Coagulation dysfunction or active internal hemorrhage.
  3. Patients with uncontrolled active infection,HIV,viral hepatitis.
  4. Peripheral nerve lesion≥grade 1 following NCI-CTC 5.
  5. Patients with serious cardiovasculardisease including history of cerebral vascular accident , myocardial infarction,hypertension,angina,heart failure(NYHA grade 2-4) within the last 6 months.
  6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study.
  7. Patients was involved in another study within the last 30 days.
  8. Patients was mental disorders.
  9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.

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IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04046094

Sponsor: University of Kansas Medical Center

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
  • Cisplatin-ineligible, muscle invasive bladder cancer
  • Adequate organ and marrow functions
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control

Exclusion Criteria:

  • Patient simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipated use of other investigational agents while participating in this study
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
  • Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
  • Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder
  • Uncontrolled intercurrent illness
  • Current consumption of tobacco products
  • History of glucose-6-phosphate dehydrogenase (G6PD) deficiency

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Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma


Condition: Upper Tract Urinary Carcinoma, Muscle-invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04099589

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  1. bladder cancer of T2-4aN0M0
  2. upper tract urinary carcinoma of T1-3N0M0 and high grade
  3. ECOG 0-1
  4. good organ function
  5. no previous chemotherapy or immunotherapy
  6. Informed consent form signed

Exclusion Criteria:

  1. unable to receive chemotherapy or surgery due to physical abnormalities
  2. previous cancer history
  3. active tuberculosis
  4. HIV
  5. autoimmune disease
  6. anticipating other clinical studies

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Efficacy of Atezolizumab Concurrent With Radiotherapy in Patients With Muscle-invasive Bladder cáncer (Study ATEZOBLADDERPRESERVE)


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04186013

Sponsor: Spanish Oncology Genito-Urinary Group

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Patients must be 18 years of age or older.
  2. Patients have histologically-confirmed diagnosis of muscle-invasive urothelial carcinoma of the bladder, in clinical stages T2-4a N0 M0, who are not candidates for radical cystectomy by medical reasons, refusal or patient's choice.
  3. Patients who refuse treatment with cisplatin-based chemotherapy or in whom treatment with cisplatin-based therapy is not appropriate.
  4. Patients must have ECOG performance status 0 to
  5. Patients must have adequate bone marrow function as defined by absolute neutrophil count >1.500/mm3; platelets >100.000/mm3 and HB ≥ 9g/dl.
  6. Patients must have adequate renal and liver function as defined by calculated creatinine clearance >15ml/min.
  7. Total bilirubin, SGOT (AST) and/or SGPT (ALT) < 2,5 times the upper limit of normal.
  8. International Normalized Ration (INR) or Prothrombin Time (PT): ≤1.5 X ULN unless participant is receiving anticoagulant therapy (as long as PT or PTT is within therapeutic range of intended use of anticoagulants).
  9. Activated Partial Thromboplastin Time (aPTT): ≤1.5 X ULN unless participant is receiving anticoagulant therapy (as long as PT or PTT is within therapeutic range of intended use of anticoagulants).
  10. Female participant of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  11. Female participants of childbearing potential should be willing to use two methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  12. Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy (1).
  13. A paraffin-embedded tumour sample must be available for the associate molecular study.

Exclusion Criteria:

  • 1. Previous treatment with radiotherapy to the bladder, systemic chemotherapy or immune checkpoint inhibitors. Prior intravesical BCG treatment for non-muscle invasive bladder cancer is allowed. 2. Presence of regional lymph node or metastatic extension of the disease. 3. Concurrent treatment with other experimental drugs (within 30 days prior to study entry) or other anti-cancer therapy. 4. History of prior malignancies within the preceding 5 years other than previously treated basal cell carcinoma of the skin, non-muscle invasive bladder cancer, incidental prostate carcinoma Stage T1a well differentiated prostatic carcinoma in men (Gleason = 3+3, PSA <5) and carcinoma in situ of the cervix. 5. Evidence of tumour-related moderate/severe hydronephrosis unless stented or with nephrostomy to preserve renal function. 6. Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative chemoradiotherapy. 7. Bulky T3/T4a tumours unsuitable for curative treatment (i.e. > 5 cm in any dimension). Tumours measures must be done post-TUR via CT scan. 8. Patients with serious uncontrolled infection. 9. Has a known history of active BT (Bacillus Tuberculosis). 10. Has known history of, or any evidence of active, non-infectious pneumonitis. 11. Autoimmune diseases other than vitiligo, type I diabetes mellitus, residual hypothyroidism requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. 12. Positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid antibody (HCV-Ab) indicating acute or chronic infection. 13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 14. Subjects with a condition requiring systemic treatment with either corticosteroids (equivalent to > 10 mg/day prednisone) or other immune-suppressive medications within 14 days of study drug administration. 15. Women of child-bearing potential unwilling to be abstinent or use effective methods of birth control. 16. General medical or psychological conditions that would preclude appropriate informed consent or compliance with the protocol. (1) Acceptable methods of effective contraception:
  • Complete sexual abstinence for 14 days before the start of study treatment to 5 months after completion of the investigational treatment.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), or tubal ligation at least six weeks before taking study treatment.
  • Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
  • Intrauterine device or system with a documented failure less than 1%.
  • Double barrier method with spermicide.

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EpiCheck and Short-term Intensive Chemoresection in NMIBC


Condition: Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04162704

Sponsor: Aarhus University Hospital

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients with a known history of Ta HG with recurrent disease
  • Patients referred to short-term, intensive chemoresection
  • Patients older than 18 years

Exclusion Criteria:

  • Known allergy or intolerance to Mitomycin
  • Incontinence or small bladder capacity (< 100 mL)
  • Previous pelvic radiation therapy

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Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer


Condition: Non-Muscle Invasive Bladder Cancer (NMIBC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04179162

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Recurrent high-grade NMIBC Tis (with TaHG, or T1 also acceptable) within 24 months of the last treatment with BCG (with or without IFN)
  • Pathologic confirmation of stage, grade, and urothelial histology by the Department of Pathology at MSK
  • All visible papillary lesions macroscopically resected within 60 days of treatment initiation
  • Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy) within 12 months from the start of treatment
  • Receipt of restaging transurethral resection (TUR) for any tumor with invasion into the lamina propria (HGT1) as part of standard care
  • Age ≥18 years
  • Karnofsky performance status ≥60%
  • Informed consent

Exclusion Criteria:

  • Positive pregnancy test
  • Known contraindications to BCG
  • History of systemic hypersensitivity reaction or history of febrile systemic BCG reaction
  • Febrile illness or persistent gross hematuria
  • Active tuberculosis
  • Immunosuppression due to congenital or acquired immune deficiency, concurrent immune suppressive disease, systemic cancer therapy, or chronic immunosuppressive therapy other than topical or inhaled corticosteroids
  • History of or currently being treated for muscle-invasive (i.e., stage T2 or higher) or metastatic urothelial cell carcinoma
  • Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma
  • BCG-unresponsive NMIBC as defined by the FDA:
  • HGT1 within 3 months after an induction BCG course (received ≥5 of 6 doses)
  • Persistent or recurrent high-grade NMIBC (Tis, Ta, T1) within 6 months of ≥5 of 6 doses of induction BCG therapy and ≥2 of 3 doses of maintenance BCG therapy

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Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy: a Phase II, Randomized Study


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03993249

Sponsor: Hellenic GenitoUrinary Cancer Group

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologically proven, muscle-invasive carcinoma of the bladder, cT2-T4aN0M0
  • Urothelial, squamous or glandular histology according to WHO 2016 classification (Fig 1)
  • Undergone a vigorous TURB
  • Not candidates for radical cystectomy.
  • PS:0-1
  • age >18 years old
  • Adequate bone marrow function
  • Adequate renal function

Exclusion Criteria:

    Key Exclusion Criteria:

    • Histology other than transitional-cell, squamous or adenocarcinoma
    • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer cervix or breast.
    • Previous systemic chemotherapy or prior biologic agents within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment.
    • Prior treatment with any PD-1 or PDL-1 inhibitor or anti CTLA4 agent
    • Previous pelvic radiation therapy.
    • Patients with inherited syndromes associated with hypersensitivity to ionizing radiation
    • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation
    • Any history of inflammatory bowel disease and or history of abdominal fistula
    • Previous allergy to any of the study drugs

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    Window of Opportunity Platform Study to Define Immunogenomic Changes With Pembrolizumab Alone and in Rational Combinations in Muscle-Invasive Bladder Cancer


    Condition: Bladder Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03978624

    Sponsor: UNC Lineberger Comprehensive Cancer Center

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 99 Years
    • Gender: All

    Inclusion Criteria:

    • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
    • Subjects must agree to donate tumor tissue from their transurethral resection of the bladder tumor (TURBT) and from their cystectomy, as well as agree to donate whole blood prior to initiating therapy, and at cystectomy.
    • Age ≥18 years at the time of consent.
    • Eastern Cooperative Oncology Group performance status of ≤ 2.
    • Histological confirmation of urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible. Pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded.
    • Subject has clinical stage T2-T4a N0/X M0 urothelial carcinoma. Clinical T stage is based on the pre-study standard of care transurethral resection of the bladder tumor (TURBT) sample and imaging studies (abdominal/pelvic CT or MRI scan and CT scan of the chest performed within 4 weeks prior to treatment initiation).
    • Available formalin-fixed paraffin-embedded (FFPE) archival tumor specimen that contains sufficient tissue to generate at least 15 (preferably 20) unstained slides, each with tissue sections that are 5
    • 10 microns thick.
    • Subject is planned to undergo definitive surgery (radical cystectomy).
    • Subject demonstrates adequate organ function as defined by the protocol; all screening laboratory assessments should be performed within 10 days of treatment initiation.
    • Subject refuses to receive or is ineligible to receive cisplatin-based neoadjuvant chemotherapy. Determination of ineligibility for cisplatin is based on at least one of the following criteria:
    • Eastern Cooperative Oncology Group performance status of 2
    • Glomerular filtration rate (GFR) per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ≤ 60 mL/min
    • NCI CTCAE v5.0 Grade ≥ 2 hearing loss
    • NCI CTCAE v5.0 Grade ≥ 2 neuropathy
    • Female subjects of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of the study treatment.
    • Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Appendix D, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. -Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Appendix D, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    • Subject is able to tolerate and retain oral medication.
    • Life expectancy greater than 3 months.

    Exclusion Criteria:

    • Subject is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of pembrolizumab.
    • Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Inhaled and topical steroids are allowed.
    • Subject has a known history of active tuberculosis.
    • Subject has known hypersensitivity to pembrolizumab or any of its excipients.
    • Subject has allergy to benzamide or inactive ingredients of entinostat.
    • Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    • Subject has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Subject has a history of (non-infectious) pneumonitis that required steroids or a current pneumonitis.
    • Subject has an active infection requiring systemic therapy.
    • Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Please note that subjects with Grade ≥2 peripheral neuropathy, are allowed on this study.
    • Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
    • Subject has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    • Subject has had prior systemic cytotoxic chemotherapy for urothelial carcinoma (prior intravesicular chemotherapies are permitted).
    • Subject is receiving histone deacetylase inhibitors, including valproic acid, DNA methyltransferase inhibitors.
    • Subject is receiving drugs that are known to inhibit or induce P-gp (see Appendix B).
    • Subject has gastrointestinal impairment that may significantly affect absorption of entinostat, such as ulcerative disease, malabsorption syndrome, and a history of small bowel resection.
    • Subject has received prior radiation therapy to the bladder for the purpose of treating urothelial carcinoma.
    • Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    • Subject has known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] has been detected).
    • Subject has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
    • Subject uses drugs or herbal supplements that are known sensitive cytochromes P450 (CYP) substrates of CYP1A2, CYP2C8, CYP3A with narrow therapeutic range

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