Pembrolizumab for Muscle Tissue
Phase-Based Progress Estimates
Effectiveness
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Muscle Tissue+4 More
Pembrolizumab - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol. Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Eligible Conditions
- Muscle Tissue
- Localized Cancer
- Transitional Cell, Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: 2 years
2 years
Benefit from Treatment
Bladder-Intact Overall Survival
Clinical Complete Response Rate (CRR)
Invasive Bladder Recurrence Free Survival
Metastasis Free Survival
Overall Survival (OS)
Positive Predictive Value between PD-L1 Expression and clinical complete response
Positive Predictive Value between TMB and clinical complete response
Recurrence Free Survival (RFS)
6 months
Assess adverse events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Pembrolizumab + Etoposide
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
20%Cough
20%Diarrhoea
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Rash
13%Headache
11%Insomnia
11%Pruritus
11%Back pain
10%Hypothyroidism
10%Weight decreased
9%Arthralgia
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Upper respiratory tract infection
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Hyperthyroidism
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Dry skin
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Erythema
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
1%Urinary tract infection
0%Empyema
0%Pneumonia haemophilus
0%Escherichia sepsis
0%Pseudomonas infection
0%Cardiopulmonary failure
0%Myocarditis
0%Acute coronary syndrome
0%Tooth infection
0%Vertigo
0%Secondary adrenocortical insufficiency
0%Myocardial infarction
0%Vitreous haemorrhage
0%Hypopituitarism
0%Gastrointestinal viral infection
0%Diverticulum
0%Infective exacerbation of chronic obstructive airways disease
0%Food poisoning
0%Cholecystitis
0%Diverticulitis
0%Cholecystitis infective
0%Appendicitis
0%Hepatotoxicity
0%Lower respiratory tract infection
0%Spinal fracture
0%Serratia sepsis
0%Fall
0%Joint injury
0%Femur fracture
0%Skin laceration
0%Gouty arthritis
0%Dehydration
0%Type 1 diabetes mellitus
0%Spinal osteoarthritis
0%Paraneoplastic syndrome
0%Cognitive disorder
0%Cancer pain
0%Tremor
0%Aphasia
0%Cerebrovascular accident
0%Loss of consciousness
0%Confusional state
0%Prostatitis
0%Benign prostatic hyperplasia
0%Autoimmune nephritis
0%Bronchospasm
0%Chronic obstructive pulmonary disease
0%Epistaxis
0%Haemoptysis
0%Hypoxia
0%Laryngeal haemorrhage
0%Oropharyngeal pain
0%Decubitus ulcer
0%Respiratory failure
0%Embolism
0%Subacute cutaneous lupus erythematosus
0%Deep vein thrombosis
0%Peripheral embolism
0%Hypertensive crisis
0%Pericardial effusion
0%Haematuria
0%Cardiac arrest
0%Haematemesis
0%Bacteraemia
0%Limbic encephalitis
0%Colitis
0%Keratitis
0%Toxic encephalopathy
0%Urosepsis
0%Peripheral motor neuropathy
0%Cardiac failure
0%Proctitis
0%Neurogenic bladder
0%Gastroenteritis
0%Pain
0%Pneumonia aspiration
0%Bronchitis
0%Pleural effusion
0%Peripheral artery occlusion
0%Atypical pneumonia
0%Myositis
0%Paracancerous pneumonia
0%Autoimmune uveitis
0%Herpes zoster
0%Oesophagitis
0%Vena cava thrombosis
0%Influenza
0%Presyncope
0%Hyperglycaemia
Trial Design
1 Treatment Group
Experimental Group
1 of 1
Experimental Treatment
46 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Experimental Group
Drug
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Icahn School of Medicine at Mount Sinai · New York, NY
1997First Recorded Clinical Trial
0 TrialsResearching Muscle Tissue
529 CompletedClinical Trials
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,626 Previous Clinical Trials
4,948,382 Total Patients Enrolled
Vaibhav PatelLead Sponsor
Vaibhav Patel, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You must have adequate transurethral resection of bladder tumor tissue available for submission (i.e., at least 15 unstained slides or paraffin block) identified during screening.
Creatinine clearance < 60 mL/min (but ≥ 30 mL/min).
You have a hearing loss of at least grade 2.
You have neuropathy grade ≥ 2.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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