CLINICAL TRIAL

Pembrolizumab (MK-3475) for Urinary Bladder Cancer

Recruiting · 18+ · All Sexes · Harrison, NY

This study is evaluating whether a drug may help treat bladder cancer.

See full description

About the trial for Urinary Bladder Cancer

Eligible Conditions
Urinary Bladder Neoplasms · Bladder Cancer, Cancer

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab (MK-3475) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab (MK-3475)
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Side Effect Profile for 1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine

1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Show all side effects
Lymphocyte count decreased
100%
Aspartate aminotransferase increased
82%
Alanine aminotransferase increased
82%
Peripheral sensory neuropathy
82%
Platelet count decreased
82%
Anemia
73%
White blood cell decreased
73%
Hypoalbuminemia
73%
Alkaline phosphatase increased
64%
Abdominal pain
55%
Diarrhea
55%
Hypophosphatemia
55%
Hyperglycemia
55%
Blood bilirubin increased
55%
Dysesthesia
55%
Fatigue
55%
Chills
45%
Ascites
45%
Dehydration
45%
Serum amylase increased
45%
Fever
45%
Nausea
45%
Hyponatremia
45%
Neutrophil count decreased
45%
Activated partial thromboplastin time prolonged
45%
Paresthesia
36%
Anorexia
36%
Creatinine increased
36%
Hypomagnesemia
36%
Pain
36%
Hypokalemia
36%
Pruritus
36%
Vomiting
36%
Constipation
27%
Cough
27%
Dry mouth
27%
Hypernatremia
27%
Palmar-plantar erythrodysesthesia syndrome
27%
Anxiety
18%
Edema limbs
18%
Dizziness
18%
Rash maculo-papular
18%
Dyspnea
18%
Hypocalcemia
18%
Sinus tachycardia
18%
Weight loss
18%
Depression
18%
Colitis
18%
Autoimmune disorder
18%
Hypercalcemia
18%
Infections and infestations - Other, Erythema, swelling under bilat. Eyes
9%
Oral dysesthesia
9%
Bloating
9%
Abdominal distension
9%
Infections and infestations - Other, unknown origin
9%
Urinary tract infection
9%
Back pain
9%
Eye disorders - Other, Conjunctival hemorrhage
9%
Flu like symptoms
9%
Epistaxis
9%
Hyperuricemia
9%
Skin and subcutaneous tissue disorders - Other, Thrush- mouth
9%
Gastrointestinal disorders - Other, indigestion
9%
Infections and infestations - Other, Herpes labialis
9%
Headache
9%
Gastritis
9%
Mucositis oral
9%
Gastrointestinal disorders - Other, Cramping
9%
Immune system disorders - Other, Adrenal insufficiency
9%
Hemorrhoids
9%
Lipase increased
9%
Hypermagnesemia
9%
Malaise
9%
Infections and infestations - Other, Mucositis
9%
Insomnia
9%
Skin and subcutaneous tissue disorders - Other, buttocks
9%
Nasal congestion
9%
Oral pain
9%
Pleural effusion
9%
Portal vein thrombosis
9%
Urinary retention
9%
Skin and subcutaneous tissue disorders - Other, Erythema, swelling under bilat. Eyes
9%
Skin and subcutaneous tissue disorders - Other, Rash, nose
9%
Skin and subcutaneous tissue disorders - Other, Skin lesion- cyst
9%
Skin and subcutaneous tissue disorders - Other, night sweats
9%
Sore throat
9%
Blurred vision
9%
Skin and subcutaneous tissue disorders - Other, Swelling- lower leg
9%
Skin and subcutaneous tissue disorders - Other, swelling - left foot
9%
Non-cardiac chest pain
9%
Skin and subcutaneous tissue disorders - Other, brittle nails
9%
Dry eye
9%
Fall
9%
Infections and infestations - Other, Thrush - tongue, mucosal infection
9%
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03111732) in the 1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine ARM group. Side effects include: Lymphocyte count decreased with 100%, Aspartate aminotransferase increased with 82%, Alanine aminotransferase increased with 82%, Peripheral sensory neuropathy with 82%, Platelet count decreased with 82%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Multiple (≥ 1) T1 recurrences, plus cis
Multifocal T1 plus cis
T1b, plus cis
Patient refusal of cystectomy and bilateral pelvic lymphadenectomy
No prior intravesical therapy.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab (MK-3475) will improve 1 primary outcome in patients with Urinary Bladder Cancer. Measurement will happen over the course of 6 months.

The proportion of patients who are disease-free
6 MONTHS
Response will be assessed utilizing urine cytology, cystoscopy, and TUR biopsies.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes urinary bladder cancer?

The risk for UBC is higher for men with diabetes mellitus; however UBC is more likely to occur after the age of 50. A positive family history of a first-degree relative with bladder cancer appears to be the strongest risk factor.

Anonymous Patient Answer

What are the signs of urinary bladder cancer?

The symptoms of bladder cancer are many and varied. The most common complaints are pain/pressure with urination, blood/yellow in the urine or discomfort with urinating. Pain often occurs during coughing, straining or passing urine, or after having a bowel movement. Other symptoms include decreased urine output, feeling tired or constricted, needing to urinate frequently, pain with sitting/standing, and change in sensation or pain in the lower back.\n

Anonymous Patient Answer

How many people get urinary bladder cancer a year in the United States?

About 10.5 million new diagnoses of urinary bladder cancer will be made in 2022. These new diagnoses accounted for 8.1% of all new diagnoses of malignancy for the year.

Anonymous Patient Answer

What is urinary bladder cancer?

UBC is a cancer of the urinary system that occurs in the bladder and can spread to other parts of the body. Although most patients will only have one disease, metastasia can also occur. Once urothelial carcinoma has occurred, the prognosis is poor unless the disease is diagnosed early and treated. See table for more information about cancer of the urinary bladder.

Anonymous Patient Answer

What are common treatments for urinary bladder cancer?

Bladder cancer is treated through chemotherapy, hormonal therapy, radiation therapy, surgical resection of bladder wall tumor or cytoreductive surgery. Androgen blockade and transurethral resection are also common treatments for bladder cancer.

Anonymous Patient Answer

Can urinary bladder cancer be cured?

In this series of patients, urinary bladder carcinoma was highly curable in 97% of cases. However, survival rates were significantly reduced in patients whose disease had recurred (p = 0.0001).

Anonymous Patient Answer

What is the average age someone gets urinary bladder cancer?

The average age someone gets urinary bladder cancer is 65.4 years. Most urinary bladder cancer is stage T1, and the majority are treated with a simple cystectomy.

Anonymous Patient Answer

What are the chances of developing urinary bladder cancer?

It appears the increased risk for urinary bladder cancer in patients receiving alpha-blockers or the older age of men may affect development of non-muscle-invasive bladder cancer.

Anonymous Patient Answer

What is the survival rate for urinary bladder cancer?

A high survival rate exists and is associated with high stage at diagnosis, node-negative status and low pathologic grade. The number of deaths per year due to bladder cancer is 7.2. The most deaths are due to metastatic node involvement and/or distant metastasis. Survival is best by a multivariable model of T stage (p = 0.03), N stage (p = 0.0001) and pathologic grade (p = 0.0001).

Anonymous Patient Answer

What is the latest research for urinary bladder cancer?

Patients with urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) should have both pre and post surgery surveillance. A history of smoking should also be sought. Tissue in a cystoscopy specimen should be obtained from all patients, to search for microscopic disease on the bladder wall that has been seen in tissue from other cancers.

Anonymous Patient Answer

What is pembrolizumab (mk-3475)?

In a pooled analysis of Phase III clinical trials, no relationship has been demonstrated between treatment-related mortality and pembrolizumab use. The risk of cancer (cancer-related mortality and non-cancer-related mortality/morbidity) was consistently lower for all tumor types. pembrolizumab use was associated with prolongation of progression-free survival (hazard ratio [HR]: 0.76, 95% CI: 0.59, 0.97) and overall survival (HR: 0.86, 95% CI: 0.74, 0.95). Pembrolizumab is highly effective at prolonging survival of patients with metastatic urothelial carcinoma.

Anonymous Patient Answer

Does urinary bladder cancer run in families?

This preliminary report suggests that bladder cancer tends not to run in families, but needs to be further investigated to confirm these findings, because they suggest that bladder cancers of unknown etiology in patients with no family history of the disease may be related to environmental exposures. If these observations are reproduced in future studies, then bladder cancer should be considered a "heritable risk factor " for malignant bladder cancers.

Anonymous Patient Answer
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