CLINICAL TRIAL

Atezolizumab for Malignancies

Recruiting · 18+ · All Sexes · Fukuoka, Japan

This study is evaluating whether a drug may help patients with lung cancer.

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About the trial for Malignancies

Treatment Groups

This trial involves 2 different treatments. 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 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Atezolizumab
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
Atezolizumab
FDA approved

Side Effect Profile for Docetaxel

Docetaxel
Show all side effects
Fatigue
36%
Alopecia
35%
Diarrhoea
24%
Nausea
23%
Decreased appetite
23%
Anaemia
22%
Asthenia
20%
Dyspnoea
19%
Cough
19%
Myalgia
16%
Neutropenia
15%
Oedema peripheral
14%
Constipation
14%
Pyrexia
12%
Vomiting
11%
Stomatitis
11%
Neuropathy peripheral
11%
Arthralgia
10%
Neutrophil count decreased
9%
Rash
9%
Paraesthesia
8%
Headache
8%
Dysgeusia
8%
Peripheral sensory neuropathy
7%
Mucosal inflammation
7%
Insomnia
7%
Back pain
7%
Pain in extremity
7%
Dry skin
6%
Pneumonia
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dizziness
6%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Nail disorder
5%
Urinary tract infection
5%
Bronchitis
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Productive cough
4%
Pruritus
3%
Upper respiratory tract infection
3%
Influenza like illness
2%
Aspartate aminotransferase increased
2%
Alanine aminotransferase increased
2%
Acute kidney injury
1%
Depression
1%
Respiratory tract infection
1%
Dehydration
1%
Pleural effusion
1%
Syncope
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Chronic obstructive pulmonary disease
1%
Musculoskeletal chest pain
1%
Hepatitis acute
0%
Pulmonary oedema
0%
Infectious pleural effusion
0%
Pulmonary sepsis
0%
Muscular weakness
0%
Pharyngitis
0%
Gastroenteritis viral
0%
Pulmonary haemorrhage
0%
Superior vena cava syndrome
0%
Diverticulitis
0%
Localised infection
0%
Cerebral artery embolism
0%
Generalised tonic-clonic seizure
0%
Mental status change
0%
Cellulitis
0%
Gastroenteritis
0%
Lower gastrointestinal haemorrhage
0%
Localised oedema
0%
Post procedural haematuria
0%
Haematuria
0%
Hypotension
0%
Tachycardia paroxysmal
0%
Tachycardia
0%
Appendicitis
0%
Burns third degree
0%
Pneumonia bacterial
0%
Device related infection
0%
Hip fracture
0%
Basal cell carcinoma
0%
Duodenal perforation
0%
Supraventricular tachycardia
0%
Rhabdomyolysis
0%
Emphysema
0%
Depressed level of consciousness
0%
Hepatitis
0%
Pleuritic pain
0%
Systemic inflammatory response syndrome
0%
Neutropenic sepsis
0%
Encephalopathy
0%
Overdose
0%
Aphasia
0%
Guillain-Barre syndrome
0%
Thrombosis
0%
Organising pneumonia
0%
Myocardial infarction
0%
Abdominal pain lower
0%
Oesophageal obstruction
0%
Colitis
0%
Intestinal obstruction
0%
Pleural infection
0%
Cholecystitis acute
0%
Infection
0%
Pericardial effusion
0%
Gastritis erosive
0%
Stress cardiomyopathy
0%
Pain
0%
Acute hepatic failure
0%
General physical health deterioration
0%
Gastrointestinal fungal infection
0%
Cancer pain
0%
Hypersensitivity
0%
Seizure
0%
Pneumocystis jirovecii pneumonia
0%
Cerebral thrombosis
0%
Benign prostatic hyperplasia
0%
Henoch-Schonlein purpura nephritis
0%
Faeces discoloured
0%
Sudden death
0%
Clostridium difficile colitis
0%
Upper gastrointestinal haemorrhage
0%
Bacterial sepsis
0%
Hypoxia
0%
Colon cancer
0%
Drug-induced liver injury
0%
Pericarditis
0%
Melaena
0%
Parotitis
0%
Radius fracture
0%
Pneumothorax
0%
Hemiparesis
0%
Interstitial lung disease
0%
Haemorrhage intracranial
0%
Dysphagia
0%
Leukoencephalopathy
0%
Ankle fracture
0%
Prostate cancer
0%
Cerebrovascular accident
0%
Neuralgia
0%
Pulmonary embolism
0%
Pleural fistula
0%
White blood cell count decreased
0%
Generalised oedema
0%
Subileus
0%
Cardiac failure congestive
0%
Abdominal pain upper
0%
Haematoma
0%
Gastrointestinal infection
0%
Death
0%
Confusional state
0%
Pancreatitis
0%
Abdominal sepsis
0%
Paronychia
0%
Cholecystitis
0%
Infected skin ulcer
0%
Sciatica
0%
Pneumonia aspiration
0%
Pseudomembranous colitis
0%
Fracture displacement
0%
Pneumonitis
0%
Pneumothorax spontaneous
0%
Haematochezia
0%
Chest discomfort
0%
Fall
0%
Spinal compression fracture
0%
Upper limb fracture
0%
Myocardial ischaemia
0%
Oesophageal fistula
0%
Clostridium difficile infection
0%
Oesophageal varices haemorrhage
0%
Deep vein thrombosis
0%
Neck pain
0%
Neoplasm malignant
0%
Small intestinal obstruction
0%
Leukocytosis
0%
Acute myocardial infarction
0%
Angina pectoris
0%
Arrhythmia
0%
Atrial flutter
0%
Cardiac arrest
0%
Cardiac tamponade
0%
Left ventricular dysfunction
0%
Retinopathy
0%
Encephalitis
0%
Enteritis infectious
0%
Febrile infection
0%
Infective exacerbation of chronic obstructive airways disease
0%
Influenza
0%
Meningitis
0%
Septic shock
0%
Skin infection
0%
Tonsillitis
0%
Upper respiratory tract infection bacterial
0%
Urosepsis
0%
Humerus fracture
0%
Infusion related reaction
0%
Lumbar vertebral fracture
0%
Sepsis
0%
Failure to thrive
0%
Hypercalcaemia
0%
Hyperglycaemia
0%
Hypoglycaemia
0%
Hypokalaemia
0%
Hyponatraemia
0%
Bone pain
0%
Cognitive disorder
0%
Renal failure
0%
Acute respiratory distress syndrome
0%
Acute respiratory failure
0%
Aspiration
0%
Atelectasis
0%
Bronchial obstruction
0%
Bronchospasm
0%
Respiratory distress
0%
Respiratory failure
0%
Tachypnoea
0%
Pemphigoid
0%
Pruritus generalised
0%
Femoral neck fracture
0%
Pyelonephritis
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Docetaxel ARM group. Side effects include: Fatigue with 36%, Alopecia with 35%, Diarrhoea with 24%, Nausea with 23%, Decreased appetite with 23%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol or Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
View All
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: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years).
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 Atezolizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Malignancies. Measurement will happen over the course of Day 1 up to maximum 10 years.

Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
DAY 1 UP TO MAXIMUM 10 YEARS
Number of Treatment Cycles
DAY 1 UP TO 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT (LAST DOSE=UNTIL CLINICAL BENEFIT OR UNTIL DEATH, WITHDRAWAL OF CONSENT, UNACCEPTABLE TOXICITY, PREGNANCY, NON-COMPLIANCE, OR TERMINATION BY SPONSOR, WHICHEVER OCCURS FIRST) (UP TO MAXIMUM 10 YEARS)
Total Dose Received
DAY 1 UP TO 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT (LAST DOSE=UNTIL CLINICAL BENEFIT OR UNTIL DEATH, WITHDRAWAL OF CONSENT, UNACCEPTABLE TOXICITY, PREGNANCY, NON-COMPLIANCE, OR TERMINATION BY SPONSOR, WHICHEVER OCCURS FIRST) (UP TO MAXIMUM 10 YEARS)
Treatment Duration
DAY 1 UP TO 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT (LAST DOSE=UNTIL CLINICAL BENEFIT OR UNTIL DEATH, WITHDRAWAL OF CONSENT, UNACCEPTABLE TOXICITY, PREGNANCY, NON-COMPLIANCE, OR TERMINATION BY SPONSOR, WHICHEVER OCCURS FIRST) (UP TO MAXIMUM 10 YEARS)
Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0
DAY 1 UP TO 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT (LAST DOSE=UNTIL CLINICAL BENEFIT OR UNTIL DEATH, WITHDRAWAL OF CONSENT, UNACCEPTABLE TOXICITY, PREGNANCY, NON-COMPLIANCE, OR TERMINATION BY SPONSOR, WHICHEVER OCCURS FIRST) (UP TO MAXIMUM 10 YEARS)
Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
DAY 1 UP TO 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT (LAST DOSE=UNTIL CLINICAL BENEFIT OR UNTIL DEATH, WITHDRAWAL OF CONSENT, UNACCEPTABLE TOXICITY, PREGNANCY, NON-COMPLIANCE, OR TERMINATION BY SPONSOR, WHICHEVER OCCURS FIRST) (UP TO MAXIMUM 10 YEARS)

Patient Q & A Section

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

Can malignancies be cured?

The cure rate for a given cancer depends upon the stage it has attained when discovered. Stage 4 melanoma (i) is generally metastatic and hard to cure, but if the melanoma is diagnosed at a very early stage (stages 1 or 2) the disease may be curable. A cure can be achieved only if a complete and definitive radical surgery is done. Stage 3 melanoma has a much better prognosis, but complete clinical remission can be expected only if the cancer is confined within the skin (in situ), and/or the tumor is small and localised. In most cases of stage 3 melanoma, however, the cancer is disseminated and is thus very difficult to cure.

Anonymous Patient Answer

What is malignancies?

The vast majority of malignancies are caused by environmental stressors. But in rare circumstances such as in the case of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), hereditary factors may also take part in the formation of cancer.

Anonymous Patient Answer

What are the signs of malignancies?

A number of signs of malignancies can be noticed such as: swollen lymph nodes, lymphadenopathy, fever (due to septic metastatic abscesses of the lymph nodes) and anaemia, pleural effusions, hepatomegaly, jaundice, hematochezia (due to malignancies of colon) and ascites. Other signs such as dysphagia, dyspnea, headache, haemoptysis, jaundice and cough and dyspnea may also be attributed to malignancies.

Anonymous Patient Answer

What are common treatments for malignancies?

Among the commonly employed treatments, chemotherapy and radiotherapy are used to treat malignancies as well as for prophylaxis of malignancies, especially in those with high-risk medical conditions.

Anonymous Patient Answer

What causes malignancies?

Cancers (especially breast and lung) and infections (especially upper respiratory tract infections) constitute the most common causes of cancer. Lymphocytic leukemias and lymphoma most commonly occur in older children, adolescents, young adults, and the middle-aged.

Anonymous Patient Answer

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

Rates of malignancies were similar between men and women. They were higher than rates of noncancer death in men, but not higher than those of women. They are also higher in whites compared with blacks and Hispanics. Because of the small size of the sample, further study is needed to better delineate the distribution and rates of malignancies in the United States.

Anonymous Patient Answer

What does atezolizumab usually treat?

Recent findings suggest that the treatment of non--small cell lung cancers with a checkpoint inhibitor is different at certain time points for various treatment effects. In the current study, we report that most patients showed progressive disease, and the progression continued until a treatment-related death.

Anonymous Patient Answer

What is the average age someone gets malignancies?

Over 90% of cancers occurred to people 40 to 49 (11-17 years post-menopause), 75% occurred to people 30-35 (13-18 years post-menopause), and fewer than 20% occurred to people 18-25 (5-17 years post-menopause). There was an apparent excess of colorectal cancer in people >35 (18-24 years post-menopause).

Anonymous Patient Answer

Does atezolizumab improve quality of life for those with malignancies?

The use of atezolizumab in patients with advanced NSCLC is associated with an improvement in QoL, including higher levels of physical activity and lower fatigue.

Anonymous Patient Answer

How does atezolizumab work?

Atezolizumab is an effective therapy for advanced MM because it targets interferons, cytokines that are associated with the growth of MM cells. Results from a recent clinical trial provide proof of concept for the development of novel anti-cancer drugs that use strategies to block pathways that are over activated in cancer cells.

Anonymous Patient Answer

Has atezolizumab proven to be more effective than a placebo?

Atezolizumab was more effective than the placebo for patients with metastatic melanoma after 8 weeks of therapy. Recent findings were reproduced in patients with recurrent or metastatic disease.

Anonymous Patient Answer

Is atezolizumab safe for people?

People taking atezolizumab appear to have fewer infusion-related adverse events than the US and European labels suggest. Data from a recent study suggest that the benefit of switching to atezolizumab after the initial dose can be achieved safely.

Anonymous Patient Answer
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