Pembrolizumab for Muscle Tissue

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Muscle Tissue+4 More
Pembrolizumab - Drug
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

1 of 3

Other trials for Muscle Tissue

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

2 of 3
This is further along than 68% of similar trials

Other trials for Muscle Tissue

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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab + Etoposide ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

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: Drug
Treatment
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
Photo of icahn school of medicine at mount sinai 1Photo of icahn school of medicine at mount sinai 2Photo of icahn school of medicine at mount sinai 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.