Atezolizumab for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Houston Methodist Hospital, Houston, TX
Melanoma+2 More
Atezolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Neoadjuvant Atezolizumab in Cutaneous Melanoma

See full description

Eligible Conditions

  • Melanoma
  • Cutaneous Melanoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Atezolizumab will improve 2 primary outcomes and 3 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 63 months.

63 months
Number of participants completing neoadjuvant atezolizumab
Number of participants with treatment-related adverse events
Pathological response rate in primary tumor and sentinel lymph node(s)
Two-year overall survival (OS) rate
Two-year recurrence-free survival (RFS) rate

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Atezolizumab
Fatigue
27%
Decreased appetite
25%
Cough
24%
Asthenia
19%
Dyspnoea
19%
Constipation
18%
Nausea
18%
Pyrexia
18%
Diarrhoea
16%
Arthralgia
13%
Vomiting
12%
Anaemia
12%
Rash
11%
Back pain
11%
Musculoskeletal pain
11%
Headache
10%
Chest pain
9%
Weight decreased
9%
Insomnia
9%
Pruritus
9%
Oedema peripheral
9%
Pain in extremity
9%
Dizziness
8%
Haemoptysis
7%
Aspartate aminotransferase increased
7%
Upper respiratory tract infection
7%
Myalgia
7%
Influenza like illness
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Nasopharyngitis
6%
Productive cough
6%
Dry skin
5%
Depression
5%
Musculoskeletal chest pain
5%
Paraesthesia
4%
Neuropathy peripheral
4%
Urinary tract infection
4%
Abdominal pain
4%
Stomatitis
3%
Pneumonia
3%
Dysgeusia
3%
Pleural effusion
2%
Malaise
2%
Neutropenia
2%
Pneumonitis
1%
Respiratory tract infection
1%
Sepsis
1%
Peripheral sensory neuropathy
1%
Pulmonary embolism
1%
Alopecia
1%
Mucosal inflammation
1%
Bone pain
1%
Lacrimation increased
1%
Haemorrhage intracranial
0%
Generalised oedema
0%
Supraventricular tachycardia
0%
Death
0%
Gastrointestinal fungal infection
0%
Cholecystitis
0%
Spinal compression fracture
0%
Drug-induced liver injury
0%
Abdominal sepsis
0%
Bacterial sepsis
0%
Gastrointestinal infection
0%
Paronychia
0%
Dehydration
0%
Neoplasm malignant
0%
Colon cancer
0%
Interstitial lung disease
0%
Confusional state
0%
Pulmonary haemorrhage
0%
Deep vein thrombosis
0%
Haematoma
0%
Gastroenteritis viral
0%
Stress cardiomyopathy
0%
Pancreatitis
0%
Oesophageal obstruction
0%
Gastroenteritis
0%
Acute hepatic failure
0%
Pneumocystis jirovecii pneumonia
0%
Seizure
0%
Encephalopathy
0%
Hypoxia
0%
Mental status change
0%
Ankle fracture
0%
Nail disorder
0%
Burns third degree
0%
Melaena
0%
Oesophageal fistula
0%
Post procedural haematuria
0%
Prostate cancer
0%
White blood cell count decreased
0%
Acute kidney injury
0%
Pleuritic pain
0%
Fracture displacement
0%
Pyelonephritis
0%
Pericardial effusion
0%
Upper gastrointestinal haemorrhage
0%
Cellulitis
0%
General physical health deterioration
0%
Hepatitis
0%
Pericarditis
0%
Tachycardia paroxysmal
0%
Faeces discoloured
0%
Device related infection
0%
Infection
0%
Pulmonary sepsis
0%
Aphasia
0%
Basal cell carcinoma
0%
Myocardial ischaemia
0%
Intestinal obstruction
0%
Meningitis
0%
Clostridium difficile infection
0%
Organising pneumonia
0%
Neutrophil count decreased
0%
Lumbar vertebral fracture
0%
Neck pain
0%
Cerebral thrombosis
0%
Hemiparesis
0%
Pneumonia aspiration
0%
Cardiac failure congestive
0%
Guillain-Barre syndrome
0%
Parotitis
0%
Diverticulitis
0%
Oesophageal varices haemorrhage
0%
Neuralgia
0%
Cerebral artery embolism
0%
Syncope
0%
Femoral neck fracture
0%
Sudden death
0%
Chest discomfort
0%
Dysphagia
0%
Fall
0%
Lower gastrointestinal haemorrhage
0%
Left ventricular dysfunction
0%
Pharyngitis
0%
Bronchospasm
0%
Muscular weakness
0%
Upper limb fracture
0%
Appendicitis
0%
Superior vena cava syndrome
0%
Pneumothorax
0%
Haematochezia
0%
Myocardial infarction
0%
Infected skin ulcer
0%
Cholecystitis acute
0%
Localised oedema
0%
Small intestinal obstruction
0%
Radius fracture
0%
Rhabdomyolysis
0%
Depressed level of consciousness
0%
Henoch-Schonlein purpura nephritis
0%
Hypotension
0%
Thrombosis
0%
Clostridium difficile colitis
0%
Hypersensitivity
0%
Haematuria
0%
Cerebrovascular accident
0%
Generalised tonic-clonic seizure
0%
Pruritus generalised
0%
Tachycardia
0%
Colitis
0%
Abdominal pain upper
0%
Systemic inflammatory response syndrome
0%
Overdose
0%
Gastritis erosive
0%
Retinopathy
0%
Neutropenic sepsis
0%
Sciatica
0%
Leukoencephalopathy
0%
Duodenal perforation
0%
Emphysema
0%
Pleural fistula
0%
Subileus
0%
Pneumonia bacterial
0%
Pseudomembranous colitis
0%
Pneumothorax spontaneous
0%
Localised infection
0%
Hepatitis acute
0%
Abdominal pain lower
0%
Pain
0%
Pleural infection
0%
Chronic obstructive pulmonary disease
0%
Febrile infection
0%
Urosepsis
0%
Cancer pain
0%
Benign prostatic hyperplasia
0%
Febrile neutropenia
0%
Leukocytosis
0%
Acute myocardial infarction
0%
Angina pectoris
0%
Arrhythmia
0%
Atrial fibrillation
0%
Atrial flutter
0%
Cardiac arrest
0%
Cardiac tamponade
0%
Encephalitis
0%
Enteritis infectious
0%
Infectious pleural effusion
0%
Infective exacerbation of chronic obstructive airways disease
0%
Influenza
0%
Lower respiratory tract infection
0%
Lung infection
0%
Septic shock
0%
Skin infection
0%
Tonsillitis
0%
Upper respiratory tract infection bacterial
0%
Hip fracture
0%
Humerus fracture
0%
Infusion related reaction
0%
Failure to thrive
0%
Hypercalcaemia
0%
Hyperglycaemia
0%
Hypoglycaemia
0%
Hypokalaemia
0%
Hyponatraemia
0%
Cognitive disorder
0%
Renal failure
0%
Acute respiratory distress syndrome
0%
Acute respiratory failure
0%
Aspiration
0%
Atelectasis
0%
Bronchial obstruction
0%
Pulmonary oedema
0%
Respiratory distress
0%
Respiratory failure
0%
Tachypnoea
0%
Pemphigoid
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Atezolizumab ARM group. Side effects include: Fatigue with 27%, Decreased appetite with 25%, Cough with 24%, Asthenia with 19%, Dyspnoea with 19%.

Trial Design

1 Treatment Group

Atezolizumab
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Atezolizumab 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 1 and are in the first stage of evaluation with people.

Atezolizumab
Drug
Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 63 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 63 months for reporting.

Who is running the study

Principal Investigator
N. E.
Prof. Nestor Esnaola, Professor of Surgery
The Methodist Hospital Research Institute

Closest Location

Houston Methodist Hospital - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Melanoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed informed consent form.
Female or male.
Age ≥18 years at time of signing informed consent form.
Ability to comply with the trial protocol, in the investigator's judgment.
Histologically confirmed cutaneous melanoma with pathological evidence of residual disease in place.
Clinically non-metastatic (stage I-II) disease.
Technically resectable disease (no significant vascular, neural, or bony involvement and potential to safely achieve R0 resection) per the treating surgical oncologist.
High-risk disease (clinical stage IA-IIC disease meeting criteria for sentinel lymph node biopsy as per the National Comprehensive Cancer Network guidelines [clinical stage IB-IIC (i.e., T1b-T4bN0M0) OR clinical stage IA (T1aN0M0) with high risk denoted by T1a with greater than or equal to 2 mitoses per mm2 OR lymphovascular invasion OR their combination]).
Treatment-naïve.
Eastern Cooperative Oncology Group performance status of 0-2.

Patient Q&A Section

How many people get melanoma a year in the United States?

"Melanoma affects about one in 5000 US Caucasians a year, most commonly on the head (58%), followed by body (23%) and melanoma of skin (19%). The average age at diagnosis was 59 years." - Anonymous Online Contributor

Unverified Answer

What are the signs of melanoma?

"Melanomas may produce a mass or tender node(s) in the skin. The most reliable signs are the appearance of the lesion in childhood and its appearance prior to the age of five. When a patient first visits a doctor, physicians or other medical personnel should pay attention to what the patient says. A doctor can determine if a patient will be diagnosed with melanoma by observing what the patient says to a health professional. For example, an elderly person may report signs such as dryness on palms of hands or on soles of feet, and bluish veining on the back of the arms and legs, and the skin might feel cracked, thickened, or scaly." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"Melanoma is a type of cancer that can arise in several locations within the body as a form of malignancy that is caused by a faulty genome and is often resistant to a variety of treatments. The prognosis for melanomas is strongly dependent on location and tumour thickness, and there is evidence that melanomas of the scalp have a more favourable prognosis than melanomas of the head and neck, including the scalp, eyes, lips, trunk, hands, feet and genitalia." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"It is not well understood the complex process of cellular transformation from normal to malignant transformation. While the process of wound healing does not appear essential in the development of melanoma, the process of neovascularization is suggested as a major step in tumor growth. It is suggested that modulation of this process by either chemotherapeutic or natural agents may be of benefit in the treatment of melanoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melanoma?

"Melanoma is frequently diagnosed at an advanced stage. Treatment options include surgery, radiation therapy, or chemotherapy, with or without targeted or immunotherapy. Survival of patients with melanoma is generally poor." - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"This prospective phase II study highlights the need for improved melanoma pathology, earlier diagnosis, and more effective and improved therapeutic regimens to enable cure. Results from a recent paper also highlight the need to have greater understanding of the risk factors for early-stage, metastatic melanoma and the role of the primary tumor in determining response to therapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of melanoma?

"Recent findings revealed that UV exposure and genetics are the major causes of melanoma. However, a significant percentage of melanoma cases are not caused by UV exposure. This suggests the existence of some factors that promote the tumor growth. Also, there is a good correlation between the occurrence of familial melanoma and UV exposure, indicating that familial melanoma might be caused either by a specific genetic predisposition to the disease or by a defect in regulatory genes controlling tumor formation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for melanoma?

"Clinical trials for melanoma would be most beneficial to patients with Stage 1 disease<10mm, or who are older than 70 years, as well as those with histologic or clinical features of ulceration, or ulcerated or thick melanomas. They may be less beneficial for patients with ulcerated melanomas<4.1 mm, or thin melanomas<1.5 mm, or ulcerated or thick melanomas>4.1 mm. Therefore, clinicians should consider these variables when planning clinical trials aimed at improving survival." - Anonymous Online Contributor

Unverified Answer

What is the latest research for melanoma?

"Recent literature highlights new developments in melanoma treatment, detection and prognosis. This article highlights current advances to the understanding of melanoma's development, progression and drug resistance, and aims to provide an update." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets melanoma?

"Since we can compare the data, there is a great deal of variation, partly because of differences in the age of individuals tested. Median age for melanoma patients was 68.23 years. Mean age was 64.9, and mean age at diagnosis was 55.7. In our study cohort, over half of melanoma patients were male. The age of melanoma patients differed significantly between genders, with the mean age being younger for male patients. In comparison, the median age of male patients was greater. In both male and female populations, the average age of death was younger. We would therefore look to see whether any correlation exists between the patient's survival versus the overall average age of mortality for the age at diagnosis or age at death." - Anonymous Online Contributor

Unverified Answer

What is atezolizumab?

"Atezolizumab is a humanized monoclonal antibody that binds to programmed cell death-1 and is marketed as a treatment in metastatic melanoma. A phase III trial demonstrated superiority of atezolizumab versus observation. A phase III trial of adjuvant atezolizumab in stage III melanoma did not demonstrate improved survival. In February 2011, atezolizumab was approved for use in the US and Europe. There are a number of side effects, mainly neurological. These include\nneuropathic pain, sensory neuropathy, aseptic meningitis, cerebellar syndrome, and reversible hearing loss. In August, 2012, the U.S." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating melanoma?

"Currently, no new medications are effective, but they are being researched for their potential therapeutic effects. The identification of growth-suppressing factors in melanoma tumors leads researchers to the identification of new targets for the treatment of melanoma. Targeted genetic therapy for melanoma may eventually be the most promising therapy, in part, because some of the key genes involved in the development and progression of melanoma are known. In addition, targeted therapy is more likely to succeed in melanomas than in other common cancers because melanoma is a cancer that is inherently metastatic and often more advanced before patients are diagnosed." - Anonymous Online Contributor

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