Pembrolizumab for Carcinoma, Neuroendocrine

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Penn Medicine, Philadelphia, PA
Carcinoma, Neuroendocrine+2 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effectiveness of the immunotherapy drug pembrolizumab in treating Merkel cell carcinoma before and after surgery. It also aims to assess any associated side effects. Pembrolizumab is being used in this trial to treat Carcinoma, Neuroendocrine. All patients in this trial will receive the active drug, as there is no placebo group. Pembrolizumab has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Carcinoma, Neuroendocrine

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Neuroendocrine

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Approximately 2 years

Approximately 2 years
Two Year Recurrence-Free Survival
Approximately 3 weeks
: Pathologic Response Rate
Tumor infiltrating response (TIL)
Up to 13 months
Frequency and incidence of adverse events

Trial Safety

Safety Progress

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

Other trials for Carcinoma, Neuroendocrine

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
0%Gastritis
0%Haematemesis
0%Cholecystitis infective
0%Pleural infection
0%Oedema peripheral
0%Vomiting
0%Pain
0%Pneumonia haemophilus
0%Back pain
0%Haematuria
0%Aortic aneurysm
0%Food poisoning
0%Asthenia
0%Hyperglycaemia
0%Peripheral motor neuropathy
0%Acute kidney injury
0%Autoimmune nephritis
0%Embolism
0%Neutropenia
0%Thrombocytopenia
0%Sepsis
0%Pericardial effusion
0%Keratitis
0%Diarrhoea
0%Constipation
0%Pneumonia aspiration
0%Joint injury
0%Diabetes mellitus
0%Arthralgia
0%Infusion related reaction
0%Vitreous haemorrhage
0%Fatigue
0%Type 1 diabetes mellitus
0%Secondary adrenocortical insufficiency
0%Pyrexia
0%Vertigo
0%Anaemia
0%Autoimmune uveitis
0%Febrile neutropenia
0%Myocardial infarction
0%Diverticulum
0%Nausea
0%Herpes zoster
0%Fall
0%Alanine aminotransferase increased
0%Paraneoplastic syndrome
0%Benign prostatic hyperplasia
0%Leukopenia
0%Neutropenic sepsis
0%Cardiac arrest
0%Cardiopulmonary failure
0%Hypopituitarism
0%Appendicitis
0%Atrial fibrillation
0%Proctitis
0%Acute coronary syndrome
0%Gastroenteritis
0%Gastrointestinal viral infection
0%Femur fracture
0%Dehydration
0%Colitis
0%Bronchitis
0%Decreased appetite
0%Cardiac failure
0%Chest pain
0%Loss of consciousness
0%Blood creatinine increased
0%Cancer pain
0%Syncope
0%Neurogenic bladder
0%Chronic obstructive pulmonary disease
0%Myocarditis
0%Cholecystitis
0%Influenza
0%Paracancerous pneumonia
0%Tooth infection
0%Spinal fracture
0%Spinal osteoarthritis
0%Cognitive disorder
0%Atypical pneumonia
0%Empyema
0%Hyperthyroidism
0%Hyponatraemia
0%Colon cancer
0%Aphasia
0%Dizziness
0%Hemiparesis
0%Limbic encephalitis
0%Escherichia sepsis
0%Diverticulitis
0%Infective exacerbation of chronic obstructive airways disease
0%Oesophagitis
0%Lower respiratory tract infection
0%Pneumonia
0%Hepatotoxicity
0%Bacteraemia
0%Death
0%Serratia sepsis
0%Urosepsis
0%Skin laceration
0%Gouty arthritis
0%Myositis
0%Cerebrovascular accident
0%Epistaxis
0%Pneumothorax
0%Clostridium difficile colitis
0%Upper respiratory tract infection
0%Aspartate aminotransferase increased
0%Tremor
0%Hypoxia
0%Hypotension
0%Dyspepsia
0%Pseudomonas infection
0%Confusional state
0%Transient ischaemic attack
0%Presyncope
0%Dyspnoea
0%Laryngeal haemorrhage
0%Decubitus ulcer
0%Toxic encephalopathy
0%Oropharyngeal pain
0%Deep vein thrombosis
0%Superior vena cava syndrome
0%Vena cava thrombosis
0%Nasopharyngitis
0%Prostatitis
0%Bronchospasm
0%Haemoptysis
0%Respiratory failure
0%Weight decreased
0%Headache
0%Alopecia
0%Pleural effusion
0%Pneumonitis
0%Peripheral artery occlusion
0%Musculoskeletal chest pain
0%Abdominal pain
0%Pulmonary embolism
0%Peripheral embolism
0%Rash
0%Subacute cutaneous lupus erythematosus
0%Hypertensive crisis
0%Dysphagia
0%Hypokalaemia
0%Abdominal pain upper
0%Stomatitis
0%Blood alkaline phosphatase increased
0%Hypothyroidism
0%Dysgeusia
0%Insomnia
0%Dry skin
0%Erythema
0%Pain in extremity
0%Cough
0%Pruritus
0%Hypertension
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%, Urinary tract infection with 100%, Gastritis with 0%, Haematemesis with 0%.

Trial Design

1 Treatment Group

Pembrolizumab
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Pembrolizumab
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: approximately 2 years
Closest Location: Penn Medicine · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
2019First Recorded Clinical Trial
0 TrialsResearching Carcinoma, Neuroendocrine
13 CompletedClinical Trials

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,631 Previous Clinical Trials
4,949,602 Total Patients Enrolled
7 Trials studying Carcinoma, Neuroendocrine
467 Patients Enrolled for Carcinoma, Neuroendocrine
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
345 Previous Clinical Trials
84,457 Total Patients Enrolled
John Miura, MDPrincipal InvestigatorPenn Medicine

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
You are expected to have at least 4-6 research core biopsy specimens or the equivalent amount of tissue.

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.